Publications by authors named "Helen S Marshall"

70 Publications

'B Part of It' School Leaver study: a repeat cross-sectional study to assess the impact of increasing coverage with meningococcal B (4CMenB) vaccine on carriage of Neisseria meningitidis.

J Infect Dis 2021 Sep 6. Epub 2021 Sep 6.

Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, South Australia, Australia.

Background: Recombinant protein-based vaccines targeting serogroup B meningococci protect against invasive disease, but impacts on carriage are uncertain. This study assessed carriage prevalence of disease-associated meningococci from 2018-2020, as the proportion of vaccinated adolescents increased following introduction of a school-based 4CMenB immunisation program.

Methods: Eligible participants who completed high school (age 17-25) in South Australia in the previous year had an oropharyngeal swab taken and completed a risk factor questionnaire. Disease-associated meningococci (genogroups A, B, C, W, X, Y) were detected by meningococcal and genogroup-specific polymerase chain reaction.

Results: The final analysis included 4104 participants in 2018, 2690 in 2019, and 1338 in 2020. The proportion vaccinated with 4CMenB increased from 43% in 2018, to 78% in 2019, and 76% in 2020. Carriage prevalence of disease-associated meningococci in 2018 was 225/4104 (5.5%). There was little difference between the carriage prevalence in 2019 (134/2690, 5.0%, adjusted odds ratio [aOR] 0.82, 95% CI 0.64-1.05) and 2020 (68/1338, 5.1% aOR 0.82, 95% CI 0.57-1.17) compared to 2018.

Conclusions: Increased 4CMenB uptake in adolescents was not associated with a decline in carriage of disease-associated meningococci. 4CMenB immunisation programs should focus on direct (individual) protection for groups at greatest risk of disease.
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http://dx.doi.org/10.1093/infdis/jiab444DOI Listing
September 2021

National predictors of influenza vaccine uptake in pregnancy: the FluMum prospective cohort study, Australia, 2012-2015.

Aust N Z J Public Health 2021 Aug 19. Epub 2021 Aug 19.

Menzies School of Health Research, Charles Darwin University, Northern Territory.

Objective: Ascertain predictors of inactivated influenza vaccine (IIV) uptake in pregnancy in mother-infant pairs from six Australian sites over four consecutive influenza seasons (2012-2015).

Methods: Prospective observational cohort study calculating proportions of unvaccinated and vaccinated pregnancies. Multivariable logistic regression calculating adjusted odds ratios (aOR) and 95% confidence intervals (95%CI) to determine demographic, pregnancy and birth characteristics as predictors of IIV uptake in pregnancy.

Results: Uptake of IIV was 36% (n=3,651/9,878) with only 3-4% during the first trimester. Validation of IIV receipt was obtained for 77% of vaccinated participants. Predictors of IIV uptake in pregnancy were: healthcare provider recommendation to have IIV during pregnancy (aOR 7.04 [95%CI 5.83-8.50]): GP (aOR 4.12 [95%CI 3.43-4.98]), obstetrician (aOR 4.41 [95%CI 3.45-5.64]), midwife (aOR 1.88 [95%CI 1.51-2.36]); previous IIV within 12 months of their current pregnancy (aOR 2.87 [95%CI 2.36-3.50]); and pertussis vaccination during the current pregnancy (aOR 4.88 [95%CI 4.08-5.83]). Conclusions and implications for public health: Healthcare provider discussions with pregnant women about the risks associated with influenza infection during pregnancy and early infancy and evidence about the safety and effectiveness of IIV are required. Recommending and offering IIV in pregnancy needs to be included in these discussions to improve uptake.
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http://dx.doi.org/10.1111/1753-6405.13130DOI Listing
August 2021

Social and behavioral predictors of two-doses 4CMenB vaccine series among adolescents enrolled in a cluster randomized controlled trial in Australia.

Hum Vaccin Immunother 2021 Aug 4:1-9. Epub 2021 Aug 4.

Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, Australia.

This study aimed to determine social and behavioral predictors of completing a course of 4CMenB vaccine in adolescents in a parallel cluster randomized controlled trial enrolling secondary school students (approximately 15-18 years of age) in South Australia. Participating schools were randomized to vaccination at baseline (intervention) or 12 months (control). Students assigned to the intervention group were excluded because they have received the first dose of 4CMenB vaccine at baseline. Logistic regression models examined factors associated with non-vaccination or incomplete 4CMenB doses. The study population comprised 11391 students. Overall, 8.3% (n = 946) received no doses and 91.7% (n = 10445) at least one dose. Of 10445 students who initiated their primary dose, 1334 (12.8%) did not complete the two-dose course. The final adjusted model indicated factors associated with non-vaccination in school students were older age (adjusted odds ratio; aOR 7.83, 95% CI: 4.13-14.82), smoking cigarettes (aOR 3.24, 95% CI: 1.93-5.44), exposure to passive smoke (aOR 2.64, 95% CI: 1.48-4.71), Aboriginal or Torres Strait Islander (aOR 1.77, 95% CI: 1.23-2.55), smoking water pipes (aOR 1.94, 95% CI:1.28-2.92), low socioeconomic status (aOR 1.77, 95% CI:1.21-2.60), attending government schools (aOR 1.76, 95% CI: 1.28, 2.43) and participating in intimate kissing (aOR 1.40, 95% CI:1.10-1.79). Multivariable analysis for incomplete vaccination yielded similar findings. Social and behavioral predictors of non-vaccination or incomplete MenB doses were also known risk factors for carriage of . Immunization strategies to improve MenB vaccination completion need to be tailored to social behavior of adolescents.
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http://dx.doi.org/10.1080/21645515.2021.1953345DOI Listing
August 2021

Lessons for and from the COVID-19 pandemic response - An appraisal of guidance for the public health management of Invasive Meningococcal Disease.

J Infect Public Health 2021 Aug 25;14(8):1069-1074. Epub 2021 Jun 25.

School of Public Health, The University of Adelaide, Adelaide Health and Medical Sciences Building, Corner of North Terrace and George Street, Adelaide, SA 5005, Australia; Robinson Research Institute, The University of Adelaide, Ground Floor, Norwich Centre, 55 King William Road, North Adelaide, SA 5006, Australia. Electronic address:

Background: COVID-19 has focussed public attention on the management of communicable disease like never before. Surveillance, contact tracing, and case management are recognised as key components of outbreak prevention. Development of guidance for COVID-19 has drawn from existing management of other communicable diseases, including Invasive Meningococcal Disease (IMD). IMD is a rare but severe outcome of Neisseria meningitidis infection that can be prevented through vaccination. Cases still occur sporadically, requiring ongoing surveillance and consistent management. To this end, national and international public health agencies have developed and published guidance for identification and management of IMD cases.

Aim: To assess national and international guidelines for the public health management of IMD, with a focus on the recommendations for identification and management of "close contacts" to IMD cases.

Methods: Guidelines from six national and international public health agencies were assessed using a modified version of the Appraisal of Guidelines, Research and Evaluation (AGREE II) Instrument in four key domains: stakeholder involvement, developmental rigour, clarity, and applicability. A direct comparison of terminology and recommendations for identification and management of close contacts to IMD cases was also conducted.

Results: Guidelines from Europe and the United Kingdom rated most highly using the AGREE II Instrument, both presenting a clear, critical assessment of the strength of the available evidence, and the risks, costs, and benefits behind recommendations for management of close contacts. Direct comparison of guidelines identified inconsistencies in the language defining close contacts to IMD cases.

Conclusion: Discrepancies between guidelines could be due to limited evidence concerning mechanisms behind disease transmission, along with the lack of a consistent process for development and review of guideline recommendations. COVID-19 management has demonstrated that international collaboration for development of public health guidance is possible, a practice that should be extended to management of other communicable diseases.
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http://dx.doi.org/10.1016/j.jiph.2021.06.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8230839PMC
August 2021

School-based HPV vaccination positively impacts parents' attitudes toward adolescent vaccination.

Vaccine 2021 07 12;39(30):4190-4198. Epub 2021 Jun 12.

Speciality of Child and Adolescent Health, Faculty of Medicine and Health, University of Sydney, NSW, Australia.

Introduction: This qualitative study aimed to explore parental attitudes, knowledge and decision-making about HPV vaccination for adolescents in the context of a gender-neutral school-based Australian National Immunisation Program (NIP).

Methods: Semi-structured interviews with parents of adolescents eligible for HPV vaccination were undertaken as part of an evaluation of a cluster-randomised controlled trial of a complex intervention in 40 schools (2013-2015). In this qualitative study, we purposively recruited a nested sample of parents from 11 schools across two Australian jurisdictions. Interviews explored parent knowledge and understanding of the HPV vaccine program; HPV vaccination decision-making; their adolescent's knowledge about HPV vaccination; and their adolescent's understanding about HPV vaccination, sexual awareness and behaviour. Transcripts were analysed using inductive and deductive thematic analysis.

Results: Parents' of 22 adolescents had positive attitudes towards the program; the school-based delivery platform was the key driver shaping acceptance of and decision-making about HPV vaccination. They had difficulty recalling, or did not read, HPV vaccination information sent home. Some adolescents were involved in discussions about vaccination, with parents' responsible for ultimate vaccine decision-making. All parents supported in-school education for adolescents about HPV and HPV vaccination. Parents' knowledge about HPV vaccination was limited to cervical cancer and was largely absent regarding vaccination in males.

Conclusions: Parents' positive attitudes towards the NIP and inclusion of the HPV vaccine is central to their vaccine decision-making and acceptance. More intensive communication strategies including school education opportunities are required to improve parents' knowledge of HPV-related disease and to promote vaccine decision-making with adolescents.
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http://dx.doi.org/10.1016/j.vaccine.2021.05.051DOI Listing
July 2021

Immunisation with the BCG and DTPw vaccines induces different programs of trained immunity in mice.

Vaccine 2021 Apr 21. Epub 2021 Apr 21.

Precision Medicine Theme, South Australian Health and Medical Research Institute, North Terrace, Adelaide, SA 5000, Australia; College of Medicine and Public Health, Flinders University, Bedford Park, SA 5042, Australia. Electronic address:

In addition to providing pathogen-specific immunity, vaccines can also confer nonspecific effects (NSEs) on mortality and morbidity unrelated to the targeted disease. Immunisation with live vaccines, such as the BCG vaccine, has generally been associated with significantly reduced all-cause infant mortality. In contrast, some inactivated vaccines, such as the diphtheria, tetanus, whole-cell pertussis (DTPw) vaccine, have been controversially associated with increased all-cause mortality especially in female infants in high-mortality settings. The NSEs associated with BCG have been attributed, in part, to the induction of trained immunity, an epigenetic and metabolic reprograming of innate immune cells, increasing their responsiveness to subsequent microbial encounters. Whether non-live vaccines such as DTPw induce trained immunity is currently poorly understood. Here, we report that immunisation of mice with DTPw induced a unique program of trained immunity in comparison to BCG immunised mice. Altered monocyte and DC cytokine responses were evident in DTPw immunised mice even months after vaccination. Furthermore, splenic cDCs from DTPw immunised mice had altered chromatin accessibility at loci involved in immunity and metabolism, suggesting that these changes were epigenetically mediated. Interestingly, changing the order in which the BCG and DTPw vaccines were co-administered to mice altered subsequent trained immune responses. Given these differences in trained immunity, we also assessed whether administration of these vaccines altered susceptibility to sepsis in two different mouse models. Immunisation with either BCG or a DTPw-containing vaccine prior to the induction of sepsis did not significantly alter survival. Further studies are now needed to more fully investigate the potential consequences of DTPw induced trained immunity in different contexts and to assess whether other non-live vaccines also induce similar changes.
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http://dx.doi.org/10.1016/j.vaccine.2021.03.084DOI Listing
April 2021

Impact of Meningococcal B Vaccine on Invasive Meningococcal Disease in Adolescents.

Clin Infect Dis 2021 07;73(1):e233-e237

Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, South Australia, Australia.

Background: From 2017, a statewide cluster randomized trial was conducted in South Australia to assess the impact of the meningococcal B vaccine 4CMenB on pharyngeal Neisseria meningitidis carriage in adolescents. Senior schools were randomized to receive the vaccine in 2017 (intervention) or 2018 (control). In this study we report the vaccine impact of 4CMenB on serogroup B invasive meningococcal disease (IMD) in 16- to 19-year-old adolescents in South Australia.

Methods: This observational time series analysis of serogroup B IMD cases compares the 14 years prior to the commencement of the trial (2003-2016) with the 2 years following 4CMenB vaccination of the 2017 adolescent cohort.

Results: Approximately 62% of year 10 and 11 students (15-16 years old) in South Australia enrolled in the trial. A total of 30 522 year 10-12 students received at least 1 dose of 4CMenB. The number of serogroup B IMD cases in 16- to 19-year old adolescents in South Australia increased on average by 10% per year from 2003 to 2016 (95% confidence interval [CI], 6%-15%, P < .001), peaking with 10 cases in 2015. Serogroup B IMD cases reduced to 5 in 2017-2018 and 1 in 2018-2019, below the expected numbers of 9.9 (95% prediction interval [PI], 3.9-17.5) and 10.9 (95% PI, 4.4-19.1), respectively. This translated to an overall reduction in the number of serogroup B IMD cases of 71% (95% CI, 15%-90%, P = .02). There were no serogroup B IMD cases in vaccinated adolescents.

Conclusions: Vaccinating adolescents with 4CMenB was associated with a reduction in group B meningococcal disease in South Australia.

Clinical Trials Registration: NCT03089086.
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http://dx.doi.org/10.1093/cid/ciaa1636DOI Listing
July 2021

Evaluating the effectiveness of the 4CMenB vaccine against invasive meningococcal disease and gonorrhoea in an infant, child and adolescent program: protocol.

Hum Vaccin Immunother 2021 05 11;17(5):1450-1454. Epub 2021 Jan 11.

Communicable Disease Control Branch, SA Health, Adelaide, Australia.

Invasive meningococcal disease causes significant morbidity and mortality worldwide, with serogroup B being one of the predominant serogroups in Australia for many years. The South Australian (SA) State Government recently funded the introduction of a 4CMenB vaccination program for infants, children and adolescents. In addition to protecting against invasive meningococcal disease, emerging evidence suggests the 4CMenB vaccine may also be effective against gonorrhoea due to genetic similarities between . The proposed project aims to evaluate the effectiveness of the SA 4CMenB vaccination program against invasive meningococcal disease and gonorrhoea through a combination of observational studies using routine surveillance and research data. The main methodological approaches involve an interrupted time series regression model, screening, and case-control analyses with different sets of controls to estimate vaccine impact and effectiveness. These analyses are designed to minimize potential biases inherent in all observational studies and to provide critical data on the effectiveness of the 4CMenB vaccine against two diseases of major global public health concern.
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http://dx.doi.org/10.1080/21645515.2020.1827614DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8078704PMC
May 2021

Safety of maternal pertussis vaccination on pregnancy and birth outcomes: A prospective cohort study.

Vaccine 2021 01 19;39(2):324-331. Epub 2020 Dec 19.

Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Adelaide, South Australia, Australia; Robinson Research Institute, Adelaide Medical School, University of Adelaide, Adelaide, SA, Australia. Electronic address:

Objective: To evaluate the safety of maternal pertussis vaccination on pregnancy and birth outcomes.

Methods: The study population comprised 1272 healthy nulliparous pregnant women who participated in Screening Tests to identify poor Outcomes in Pregnancy (STOP) study at two obstetric hospitals in South Australia between 2015 and 2018. Participants were followed prospectively, with vaccination (confirmed by medical records), extensive amounts of pregnancy and birth outcome data collected by research midwives. Adjusted relative risks (aRRs) and hazard ratios (aHRs) were estimated accounting for time-varying vaccine exposure and the temporal nature of each outcome.

Results: Of the 1272 women included in this study, 80.1% (n = 1019) received maternal pertussis vaccination. Vaccinated women had an average 0.22 weeks (95% CI 0.001, 0.44) longer gestation at delivery compared to unvaccinated women. Maternal pertussis vaccination was not associated with chorioamnionitis (aRR 0.71, 95% CI 0.27,1.82), gestational hypertension (aHR 1.24, 95% CI, 0.66, 2.30), preeclampsia (aHR 0.75, 95% CI 0.47, 1.18) nor preterm birth (aHR 0.99, 95% CI 0.47, 2.07). Neither risk of low birth weight (aHR 0.72, 95% CI 0.41, 1.27) nor small for gestational age infants (aHR 0.67,95% CI 0.29, 1.55) were increased following maternal pertussis vaccination. No associations between pertussis vaccination during pregnancy and adverse birth outcomes including admission to the neonatal care unit, low Apgar scores, and mechanical ventilation were observed. Results were not materially changed after adjustment for maternal influenza vaccination.

Conclusion: Our study provides reassuring evidence of the safety of maternal pertussis vaccination with no increased risk of adverse pregnancy and birth outcomes. These findings support recommendations for pertussis vaccination during pregnancy to prevent morbidity and mortality associated with early-infant pertussis disease.
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http://dx.doi.org/10.1016/j.vaccine.2020.11.052DOI Listing
January 2021

Effectiveness of Meningococcal Vaccines at Reducing Invasive Meningococcal Disease and Pharyngeal Neisseria meningitidis Carriage: A Systematic Review and Meta-analysis.

Clin Infect Dis 2021 08;73(3):e609-e619

Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, South Australia, Australia.

Background: Invasive meningococcal disease (IMD), caused by Neisseria meningitidis, leads to significant morbidity and mortality worldwide. This review aimed to establish the effectiveness of meningococcal vaccines at preventing IMD and N. meningitidis pharyngeal carriage.

Methods: A search within PubMed, Embase, Scopus, and unpublished studies up to 1 February 2020 was conducted.

Results: After removal of duplicates, 8565 studies were screened and 27 studies included. Protection was provided by meningococcal C vaccines for group C IMD (odds ratio [OR], 0.13 [95% confidence interval {CI}, .07-.23]), outer membrane vesicle (OMV) vaccines against group B IMD (OR, 0.35 [95% CI, .25-.48]), and meningococcal A, C, W, Y (MenACWY) vaccines against group ACWY IMD (OR, 0.31 [95% CI, .20-.49]). A single time series analysis found a reduction following an infant 4CMenB program (incidence rate ratio, 0.25 [95% CI, .19-.36]). Multivalent MenACWY vaccines did not reduce carriage (relative risk [RR], 0.88 [95% CI, .66-1.18]), unlike monovalent C vaccines (RR, 0.50 [95% CI, .26-.97]). 4CMenB vaccine had no effect on group B carriage (RR, 1.12 [95% CI, .90-1.40]). There was also no reduction in group B carriage following MenB-FHbp vaccination (RR, 0.98 [95% CI, .53-1.79]).

Conclusions: Meningococcal conjugate C, ACWY, and OMV vaccines are effective at reducing IMD. A small number of studies demonstrate that monovalent C conjugate vaccines reduce pharyngeal N. meningitidis carriage. There is no evidence of carriage reduction for multivalent MenACWY, OMV, or recombinant MenB vaccines, which has implications for immunization strategies.

Clinical Trials Registration: CRD42018082085 (PROSPERO).
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http://dx.doi.org/10.1093/cid/ciaa1733DOI Listing
August 2021

Influenza vaccination: A qualitative study of practice level barriers from medical practitioners caring for children with special risk medical conditions.

Vaccine 2020 11 23;38(49):7806-7814. Epub 2020 Oct 23.

Adelaide Medical School, University of Adelaide, South Australia, Australia; Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, North Adelaide, South Australia, Australia; Robinson Research Institute, University of Adelaide, South Australia, Australia; South Australian Health and Medical Research Institute. Electronic address:

Background: Understanding the influenza vaccination practices of general practitioners (GP) and paediatric hospital specialists caring for children with special risk medical conditions (SRMC) is imperative for designing interventions to improve uptake. This study aimed to identify the vaccination decision making, provider practices and perceived barriers and facilitators to recommending or delivering influenza vaccine for children with SRMCs at the tertiary and primary care levels.

Methods: Nominated GPs and hospital specialists from a single tertiary hospital were interviewed to explore influenza vaccination practices and challenges for children with confirmed SRMCs. Interviews were digitally recorded, transcribed verbatim and thematic analysis was used to inductively code these data. Resulting themes were mapped across the COM-B ('capability', 'opportunity', 'motivation' and 'behaviour') theoretical framework to understanding barriers and potential interventions.

Results: Twenty-six medical practitioners (21 GPs and 5 hospital specialists) completed semi-structured interviews. Barriers, and facilitators for influenza vaccine recommendation (the intended behaviour) were thematically grouped. Opportunity themes included structural barriers (e.g. limited use of systems and processes to support the identification of children with SRMCs); recommendation as standard practice; vaccination inconvenience; lack of communication and educational resources; social acceptance and normalisation; and media messaging. Capability themes included provider communication with parents; knowledge of influenza vaccine recommendations; and professional boundaries to implement the recommendation. Themes in the Motivation category included provider clinical prioritisation and responsibility towards providing a recommendation.

Conclusions: The main barriers to influenza recommendation raised by our study participants were structural. These included lack of processes to identify children with SRMCs, limited use of reminder systems and unclear delineation of role responsibility between hospital specialists and GPs. An important driver that emerged was GPs' responsibility for providing a recommendation. To increase influenza vaccine coverage for children with SRMCs, consideration should be given to addressing practice level structural barriers and improving collaboration.
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http://dx.doi.org/10.1016/j.vaccine.2020.10.020DOI Listing
November 2020

Barriers to influenza vaccination of children hospitalised for acute respiratory illness: A cross-sectional survey.

J Paediatr Child Health 2021 03 22;57(3):409-418. Epub 2020 Oct 22.

Susan Wakil School of Nursing and Midwifery, The University of Sydney, Sydney, New South Wales, Australia.

Aim: To identify barriers to influenza vaccination of children hospitalised for acute respiratory illness in Australia.

Methods: A total of 595 parents of children hospitalised with acute respiratory illness across five tertiary hospitals in 2019 participated in an online survey. Multivariate logistic regression identified factors most strongly associated with influenza vaccination barriers.

Results: Odds of influenza vaccination were lower with lack of health-care provider (HCP) recommendation (adjusted odds ratio (aOR) 0.18; 95% confidence interval (CI): 0.08-0.38); if parents had difficulties (aOR 0.19; 95% CI: 0.08-0.47) or were 'neutral' (aOR 0.23; 95% CI: 0.06-0.82) in remembering to make an appointment; and if parents had difficulties (aOR 0.21; 95% CI: 0.07-0.62) or were 'neutral' (aOR 0.24; 95% CI: 0.07-0.79) regarding getting an appointment for vaccination. Odds were also lower if parents did not believe (aOR 0.27; 95% CI: 0.08-0.90) or were 'neutral' (aOR 0.15; 95% CI: 0.04-0.49) regarding whether the people most important to them would have their child/ren vaccinated against influenza. Children had lower odds of vaccination if parents did not support (aOR 0.09; 95% CI: 0.01-0.82) or were ambivalent (aOR 0.09; 95% CI: 0.01-0.56) in their support for influenza vaccination. Finally, lack of history of influenza vaccination of child (aOR 0.38; 95% CI: 0.18-0.81) and respondent (aOR 0.25; 95% CI: 0.11-0.56) were associated with lack of receipt of influenza vaccine before admission for acute respiratory infection.

Conclusions: Assisting parents in remembering and accessing influenza vaccination and encouraging health-care providers to recommend vaccination may increase uptake.
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http://dx.doi.org/10.1111/jpc.15235DOI Listing
March 2021

Safety and protective effects of maternal influenza vaccination on pregnancy and birth outcomes: A prospective cohort study.

EClinicalMedicine 2020 Sep 9;26:100522. Epub 2020 Sep 9.

Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, South Australia, Australia.

Background: Our study aimed to assess the safety and protective effect of maternal influenza vaccination on pregnancy and birth outcomes.

Methods: The study population comprised 1253 healthy nulliparous pregnant women in South Australia between 2015 and 2018. Participants were followed prospectively, with vaccination status (confirmed by medical records), pregnancy, and birth outcome data collected by midwives. Adjusted relative risks (aRRs) and adjusted hazard ratios (aHRs) were estimated accounting for time-varying vaccine exposure and temporal nature of each outcome.

Findings: Maternal influenza vaccination (48%, 603 of 1253) reduced the risk for pre-delivery hospitalisation with influenza like illness (aHR 0•61; 95% CI 0•39, 0•97). Maternal influenza vaccination was not associated with spontaneous abortion (aHR 0•42, 95% CI 0•12, 1•45), chorioamnionitis (aRR 0•78, 95% CI, 0•32, 1•88), gestational hypertension (aHR 0•78, 95% CI 0•47, 1•29), pre-eclampsia (aHR 0.84, 95% CI 0•54, 1•27), gestational diabetes (aHR 1•16, 95% CI 0•82, 1•66) nor preterm birth (aHR 0•94, 95% CI 0•59, 1•49). No associations between antenatal influenza vaccination and congenital anomalies, admission to the neonatal care unit, low Apgar scores, and mechanical ventilation were observed. Results were not materially changed after adjustment for pertussis vaccination. We observed a protective effect of maternal influenza vaccination on low birth weight (aHR 0•46, 95% CI 0•23, 0•94) and a marginal protective effect on small for gestational age births (aHR 0•65, 95% CI 0•40, 1•04) during periods of high influenza activity.

Interpretation: These results support the safety of maternal influenza vaccination and suggest a protective effect in reducing the rates of low birthweight and small for gestational age births.

Funding: There was no funding for this study.
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http://dx.doi.org/10.1016/j.eclinm.2020.100522DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7490992PMC
September 2020

The impact of a meningococcal protein-based serogroup B vaccine on serogroup W invasive disease in children.

Clin Infect Dis 2020 Aug 26. Epub 2020 Aug 26.

Department of Zoology, University of Oxford, Oxford, United Kingdom.

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http://dx.doi.org/10.1093/cid/ciaa1253DOI Listing
August 2020

Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants.

N Engl J Med 2020 07;383(5):426-439

From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).

Background: Respiratory syncytial virus (RSV) is the dominant cause of severe lower respiratory tract infection in infants, with the most severe cases concentrated among younger infants.

Methods: Healthy pregnant women, at 28 weeks 0 days through 36 weeks 0 days of gestation, with an expected delivery date near the start of the RSV season, were randomly assigned in an overall ratio of approximately 2:1 to receive a single intramuscular dose of RSV fusion (F) protein nanoparticle vaccine or placebo. Infants were followed for 180 days to assess outcomes related to lower respiratory tract infection and for 364 days to assess safety. The primary end point was RSV-associated, medically significant lower respiratory tract infection up to 90 days of life, and the primary analysis of vaccine efficacy against the primary end point was performed in the per-protocol population of infants (prespecified criterion for success, lower bound of the 97.52% confidence interval [CI] of ≥30%).

Results: A total of 4636 women underwent randomization, and there were 4579 live births. During the first 90 days of life, the percentage of infants with RSV-associated, medically significant lower respiratory tract infection was 1.5% in the vaccine group and 2.4% in the placebo group (vaccine efficacy, 39.4%; 97.52% CI, -1.0 to 63.7; 95% CI, 5.3 to 61.2). The corresponding percentages for RSV-associated lower respiratory tract infection with severe hypoxemia were 0.5% and 1.0% (vaccine efficacy, 48.3%; 95% CI, -8.2 to 75.3), and the percentages for hospitalization for RSV-associated lower respiratory tract infection were 2.1% and 3.7% (vaccine efficacy, 44.4%; 95% CI, 19.6 to 61.5). Local injection-site reactions among the women were more common with vaccine than with placebo (40.7% vs. 9.9%), but the percentages of participants who had other adverse events were similar in the two groups.

Conclusions: RSV F protein nanoparticle vaccination in pregnant women did not meet the prespecified success criterion for efficacy against RSV-associated, medically significant lower respiratory tract infection in infants up to 90 days of life. The suggestion of a possible benefit with respect to other end-point events involving RSV-associated respiratory disease in infants warrants further study. (Funded by Novavax and the Bill and Melinda Gates Foundation; ClinicalTrials.gov NCT02624947.).
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http://dx.doi.org/10.1056/NEJMoa1908380DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7299433PMC
July 2020

The potential for improved protection against pertussis.

Lancet Infect Dis 2020 11 17;20(11):1220-1222. Epub 2020 Jul 17.

National Centre for Immunisation Research and Surveillance, Sydney Children's Hospitals Network, Sydney, NSW, Australia; The Children's Hospital at Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.

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http://dx.doi.org/10.1016/S1473-3099(20)30325-XDOI Listing
November 2020

Active surveillance of acute paediatric hospitalisations demonstrates the impact of vaccination programmes and informs vaccine policy in Canada and Australia.

Euro Surveill 2020 06;25(25)

The IMPACT and PAEDS investigators are acknowledged at the end of this article.

Sentinel surveillance of acute hospitalisations in response to infectious disease emergencies such as the 2009 influenza A(H1N1)pdm09 pandemic is well described, but recognition of its potential to supplement routine public health surveillance and provide scalability for emergency responses has been limited. We summarise the achievements of two national paediatric hospital surveillance networks relevant to vaccine programmes and emerging infectious diseases in Canada (Canadian Immunization Monitoring Program Active; IMPACT from 1991) and Australia (Paediatric Active Enhanced Disease Surveillance; PAEDS from 2007) and discuss opportunities and challenges in applying their model to other contexts. Both networks were established to enhance capacity to measure vaccine preventable disease burden, vaccine programme impact, and safety, with their scope occasionally being increased with emerging infectious diseases' surveillance. Their active surveillance has increased data accuracy and utility for syndromic conditions (e.g. encephalitis), pathogen-specific diseases (e.g. pertussis, rotavirus, influenza), and adverse events following immunisation (e.g. febrile seizure), enabled correlation of biological specimens with clinical context and supported responses to emerging infections (e.g. pandemic influenza, parechovirus, COVID-19). The demonstrated long-term value of continuous, rather than incident-related, operation of these networks in strengthening routine surveillance, bridging research gaps, and providing scalable public health response, supports their applicability to other countries.
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http://dx.doi.org/10.2807/1560-7917.ES.2020.25.25.1900562DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7331140PMC
June 2020

Paediatric Active Enhanced Disease Surveillance (PAEDS) 2017 and 2018: Prospective hospital-based surveillance for serious paediatric conditions.

Commun Dis Intell (2018) 2020 06 15;44. Epub 2020 Jun 15.

Director, National Centre for Immunisation Research and Surveillance, Kids Research Institute, The Children's Hospital at Westmead, New South Wales; Professor, Discipline of Child and Adolescent Health, University of Sydney, New South Wales; Staff Specialist, Department of Microbiology and Infectious Diseases, The Children's Hospital at Westmead, New South Wales.

Introduction: The Paediatric Active Enhanced Disease Surveillance (PAEDS) network is a hospital-based active surveillance system employing prospective case ascertainment for selected serious childhood conditions, particularly vaccine-preventable diseases and potential adverse events following immunisation (AEFI). This report presents surveillance data for 2017 and 2018.

Methods: Specialist nurses screened hospital admissions, emergency department (ED) records, laboratory and other data on a daily basis in seven paediatric tertiary referral hospitals across Australia to identify children with the conditions under surveillance. In 2017 and 2018 these included acute flaccid paralysis (AFP; a syndrome associated with poliovirus infection), acute childhood encephalitis (ACE), influenza, intussusception (IS; a potential AEFI with rotavirus vaccines), pertussis, varicella-zoster virus infection (varicella and herpes zoster), invasive meningococcal, and invasive Group A streptococcus diseases. An additional social research component was added to evaluate parental attitudes to vaccination.

Results: PAEDS captured 1,580 and 925 cases for 2017 and 2018, respectively, across all conditions under surveillance. Key outcomes of PAEDS included: contribution to national AFP surveillance to reach the World Health Organization reporting targets; identification of a third human parechovirus outbreak among other infectious diseases linked to ACE; demonstration of variable influenza activity between 2017 and 2018, with vaccine effectiveness (VE) analysis demonstrating that the protection offered through vaccination is season-dependent. All IS cases associated with vaccine receipt were reported to the relevant state health department. Varicella and herpes zoster case numbers remained unchanged, with vaccine uptake found to be suboptimal among eligible children under the NIP. Enhanced pertussis surveillance continues to capture controls for VE estimation. Surveillance for invasive meningococcal disease showed predominance for serotype B at 57% over 2 years among 77 cases where serotyping was available, and surveillance for invasive group A streptococcus captured severe disease in children.

Conclusion: PAEDS continues to provide unique policy-relevant data on serious paediatric conditions using hospital-based sentinel surveillance.
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http://dx.doi.org/10.33321/cdi.2020.44.49DOI Listing
June 2020

The everchanging epidemiology of meningococcal disease worldwide and the potential for prevention through vaccination.

J Infect 2020 10 3;81(4):483-498. Epub 2020 Jun 3.

Immunisation and Countermeasures Division, Public Health England, 61 Colindale Avenue, London, UK; Paediatric Infectious Diseases Research Group (PIDRG), St. George's University of London, Cranmer Terrace, London SW17 0RE, UK. Electronic address:

Neisseria meningitidis is a major cause of bacterial meningitis and septicaemia worldwide and is associated with high case fatality rates and serious life-long complications among survivors. Twelve serogroups are recognised, of which six (A, B, C, W, X and Y) are responsible for nearly all cases of invasive meningococcal disease (IMD). The incidence of IMD and responsible serogroups vary widely both geographically and over time. For the first time, effective vaccines against all these serogroups are available or nearing licensure. Over the past two decades, IMD incidence has been declining across most parts of the world through a combination of successful meningococcal immunisation programmes and secular trends. The introduction of meningococcal C conjugate vaccines in the early 2000s was associated with rapid declines in meningococcal C disease, whilst implementation of a meningococcal A conjugate vaccine across the African meningitis belt led to near-elimination of meningococcal A disease. Consequently, other serogroups have become more important causes of IMD. In particular, the emergence of a hypervirulent meningococcal group W clone has led many countries to shift from monovalent meningococcal C to quadrivalent ACWY conjugate vaccines in their national immunisation programmes. Additionally, the recent licensure of two protein-based, broad-spectrum meningococcal B vaccines finally provides protection against the most common group responsible for childhood IMD across Europe and Australia. This review describes global IMD epidemiology across each continent and trends over time, the serogroups responsible for IMD, the impact of meningococcal immunisation programmes and future needs to eliminate this devastating disease.
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http://dx.doi.org/10.1016/j.jinf.2020.05.079DOI Listing
October 2020

Seasonal influenza vaccination for children with special risk medical conditions: Does policy meet practice?

J Paediatr Child Health 2020 Sep 1;56(9):1388-1395. Epub 2020 Jun 1.

Discipline of Paediatrics, Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.

Aim: Ensuring children with special risk medical conditions (SRMC) are protected from influenza is important. The study objective was to describe influenza vaccination practices of medical professionals caring for children with SRMC and explore characteristics associated with a vaccine recommendation.

Methods: Design: Cross-sectional survey.

Setting/participants: Treating paediatric specialists and general practitioners of children with confirmed SRMCs. Postal questionnaire administered from March to September 2018 (option for online response). Characteristics associated with providing a recommendation were explored using univariable and multivariable analyses.

Results: Overall response rate of 24.8% with the sample representative of the eligible population in terms of practice location and years practicing medicine. There was a higher response from females and sub-specialists. Of the 198 completed survey responders, 97.8% were aware of the recommendation, yet only 38.4% reported they 'always' routinely recommended influenza vaccine and fewer (19.5%) were very confident in understanding all 'medically at risk' conditions. Medical professionals were more likely to provide a recommendation always or mostly, if they received annual influenza vaccination themselves (adjusted odds ratio (aOR) 3.96, confidence interval (CI) 1.12-14.03), had confidence in understanding all 'medically at risk' conditions (aOR 1.82, CI 1.04-3.17) and perceived ownership of the responsibility to provide the recommendation (aOR 7.35, CI 1.67-32.26). Regional practising medical professionals were less likely to provide a recommendation (aOR 0.25 CI 0.10-0.70).

Conclusions: We need to improve medical professionals' knowledge through reminders and access to consistent and concise information about what constitutes a SRMC. Increasing medical professionals' engagement in the influenza vaccination programme could also provide a sense of responsibility fostering provider endorsement.
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http://dx.doi.org/10.1111/jpc.14943DOI Listing
September 2020

Impact of Meningococcal B (4CMenB) Vaccine on Pharyngeal Neisseria meningitidis Carriage Density and Persistence in Adolescents.

Clin Infect Dis 2021 07;73(1):e99-e106

Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, South Australia, Australia.

Background: Higher density of Neisseria meningitidis carriage may be associated with transmission of the meningococcus. Our aim was to establish the impact of meningococcal B (4CMenB) vaccine on N. meningitidis carriage density.

Methods: We compared 4CMenB vaccine to control among 913 South Australian students aged approximately 15-18 years in a cluster randomized trial who had N. meningitidis carriage at 12 months. Oropharyngeal swabs were collected at baseline and 12 months later to detect N. meningitidis carriage. Colony-forming units per milliliter (CFU/mL) were estimated by generating a standard curve that plotted quantitative polymerase chain reaction cycle threshold values against log-normalized CFU.

Results: Among the 913 students with N. meningitidis carriage at 12 months, there was no difference in mean carriage density between the vaccinated (n = 434; 3.80 log CFU/mL [standard deviation {SD}, 1.29]) and control group (n = 479; 3.73 log CFU/mL [SD, 1.30]; P = .51). Higher N. meningitidis carriage density at baseline was associated with an increase in the odds of persistent carriage at 12 months (n = 504; odds ratio [OR] per 1.0 log CFU/mL increase in density, 1.36 [95% confidence interval {CI}, 1.17-1.58]; P < .001). Students with baseline carriage who were vaccinated had decreased persistent N. meningitidis carriage at 12 months compared to unvaccinated students (81/260 [31%] vs 105/244 [43%]; OR, 0.60 [95% CI, .40-.90]; P = .01).

Conclusions: 4CMenB vaccine did not reduce carriage density of N. meningitidis 12 months postvaccination, despite increased carriage clearance. Higher carriage density is likely to enable transmission through prolonged periods of population exposure.

Clinical Trials Registration: NCT03089086.
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http://dx.doi.org/10.1093/cid/ciaa610DOI Listing
July 2021

Disparities in parental awareness of children's seasonal influenza vaccination recommendations and influencers of vaccination.

PLoS One 2020 9;15(4):e0230425. Epub 2020 Apr 9.

Discipline of Paediatrics, Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.

Objective: To determine parental awareness of influenza vaccination recommendations for children and explore associations with awareness.

Design: Cross-sectional survey.

Setting/participants: South Australian parents with a telephone listing in the Electronic White Pages were randomly selected.

Methods: Participants were interviewed using Computer Assisted Telephone Interviewing (CATI) during May-July 2016. Univariable and multivariable analyses explored characteristics associated with awareness; with the survey data weighted to reflect the population of SA and the probability of selection within a household.

Results: Of 539 parents, 33% were aware of the recommendation that all children (<5 years) should receive the influenza vaccine annually with 51.9% aware that children with special risk medical conditions (SRMC) should also receive the vaccine annually. Characteristics strongly associated with parental awareness of the recommendation for children aged < 5 years were knowledge of recommendation for children with a SRMC (adjusted Odds Ratio [aOR] 10.46, CI 4.44-24.63) or living in a metropolitan area (aOR 2.91, CI 1.19-7.09). There was lack of awareness in those not working (aOR 0.13, CI 0.04-0.47), with trade level education (compared with high school) (aOR 0.25 CI, 0.09-0.71) and in those born in the UK or Ireland (aOR 0.19, CI 0.04-0.85). Awareness of the recommendation for children with SRMC to receive the vaccine was strongly associated with knowledge of the influenza recommendation for children <5 years (aOR 10.22, CI 4.39-23.77) or not being born in Australia [UK/ Ireland (aOR 7.63, CI 1.86-31.31); other (aOR 3.93, CI 0.94-16.42)]. The most influential cues to future receipt were a general practitioner (GP) recommendation (63.8%) and providing influenza vaccine free for all children (37.6%). More parents who delayed or excluded vaccines believed that their children's vaccinations (in general) were unnecessary, as other children were vaccinated (42.8%) compared to those with no or minor concerns (11.1%) (p<0.0001).

Conclusions: Parental awareness of children's influenza vaccine recommendations is low. Targeted communication strategies and resources are required to establish broader community awareness of recommendations. Healthcare provider endorsement of the vaccine remains key and health care professionals, particularly GPs and paediatric specialists should be encouraged to discuss influenza vaccine with parents at every opportunity. Many parents have vaccine concerns and addressing concerns across the spectrum of hesitancy is crucial.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0230425PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7145195PMC
July 2020

The impact of new universal child influenza programs in Australia: Vaccine coverage, effectiveness and disease epidemiology in hospitalised children in 2018.

Vaccine 2020 03 24;38(13):2779-2787. Epub 2020 Feb 24.

National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, University of Sydney, Sydney, NSW, Australia; School of Paediatrics and Child Health, University of Sydney, Sydney, NSW, Australia; Department of Infectious Diseases and Microbiology, Children's Hospital Westmead, Westmead, Sydney, NSW, Australia.

Background: New jurisdictionally-based vaccination programs were established providing free quadrivalent influenza vaccine (QIV) for preschool Australian children in 2018. This was in addition to the National Immunisation Program (NIP) funded QIV for Indigenous children and children with comorbid medical conditions. We assessed the impact of this policy change on influenza disease burden and vaccine coverage, as well as report on 2018 vaccine effectiveness in a hospital-based surveillance system.

Methods: Subjects were recruited prospectively from twelve PAEDS-FluCAN sentinel hospital sites (April until October 2018). Children aged ≤16 years hospitalised with an acute respiratory illness (ARI) and laboratory-confirmed influenza were considered cases. Hospitalised children with ARI who tested negative for influenza were considered controls. VE estimates were calculated from the adjusted odds ratio of vaccination in cases and controls.

Results: A total of 458 children were hospitalised with influenza: 31.7% were <2 years, 5.0% were Indigenous, and 40.6% had medical comorbidities predisposing to severe influenza. Influenza A was detected in 90.6% of children (A/H1N1: 38.0%; A/H3N2: 3.1%; A/unsubtyped 48.6%). The median length of stay was 2 days (IQR: 1,3) and 8.1% were admitted to ICU. Oseltamivir use was infrequent (16.6%). Two in-hospital deaths occurred (0.45%). 12.0% of influenza cases were vaccinated compared with 36.0% of test-negative controls. Vaccine effectiveness of QIV for preventing influenza hospitalisation was estimated at 78.8% (95%CI: 66.9; 86.4).

Conclusions: Compared with 2017 (n = 1268 cases), a significant reduction in severe influenza was observed in Australian children, possibly contributed to by improved vaccine coverage and high vaccine effectiveness. Despite introduction of jurisdictionally-funded preschool programs and NIP-funded vaccine for children with risk factors for severe disease, improved coverage is required to ensure adequate protection against paediatric influenza morbidity and mortality.
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http://dx.doi.org/10.1016/j.vaccine.2020.02.031DOI Listing
March 2020

Psychosocial determinants of pertussis and influenza vaccine uptake in pregnant women: A prospective study.

Vaccine 2020 04 16;38(17):3358-3368. Epub 2020 Feb 16.

Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Adelaide, South Australia, Australia. Electronic address:

Objective: To identify the psychosocial factors influencing women's uptake and willingness to receive pertussis and influenza vaccine during pregnancy.

Methods: The study population comprised 1364 healthy nulliparous pregnant women who participated in a prospective cohort study at two obstetric hospitals in South Australia between 2015 and 2017. Information on women's vaccination status, sociodemographic, lifestyle and psychological state were collected at 9-16 weeks' gestation and medical case notes were checked post-delivery to verify the reported vaccination status. Poisson regression models were used to estimate the crude and adjusted prevalence ratios (aPRs) to identify psychosocial factors influencing uptake of vaccination during pregnancy.

Results: Willingness to receive the recommended maternal vaccines was high (90%). Overall, 79% and 48% received maternal pertussis and influenza vaccines respectively. There was no evidence to support the influence of psychosocial factors on women's willingness to receive immunization during pregnancy. High levels of anxiety (aPR 0.98, 95% CI: 0.87-1.09) was not associated with uptake of maternal pertussis vaccine. However, elevated depressive symptoms (aPR 1.14, 95% CI: 1.00-1.30) and very high-perceived stress during pregnancy were significantly associated with receipt of pertussis vaccination (aPR 0.87; 95% CI 0.76-0.99). Women with mild depressive symptoms (aPR 1.21, 95% CI 1.00-1.44) and mild anxiety symptoms (aPR 1.21, 95% CI: 0.99-1.48) were more likely to receive influenza vaccine during pregnancy (aPR 1.27, 95% CI: 1.08-1.49). A history of major depressive disorder was independently associated with receipt of pertussis (aPR 1.16, 95% CI 1.06-1.26) and influenza vaccination during pregnancy (aPR 1.32; 95% CI 1.14-1.58).

Conclusion: Regardless of psychosocial factors, most women reported a positive willingness to receive the recommended vaccinations during pregnancy. However, psychosocial factors influenced the uptake of pertussis and influenza vaccines during pregnancy. Psychosocial factors should be taken into consideration in designing interventions and implementation of maternal pertussis and influenza immunization programs.
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http://dx.doi.org/10.1016/j.vaccine.2020.02.020DOI Listing
April 2020

Meningococcal B Vaccine and Meningococcal Carriage in Adolescents in Australia.

N Engl J Med 2020 01;382(4):318-327

From the Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network (H.S.M.), the Robinson Research Institute and Adelaide Medical School (H.S.M., M.M.), and the School of Public Health (T.R.S.), University of Adelaide, the Communicable Disease Control Branch, SA Health (A.P.K.), and SA Pathology (A.L.), Adelaide, and the Marshall Centre for Infectious Disease Research and Training, School of Biomedical Science (C.M.K.), and the School of Medicine (P.R.), University of Western Australia, the Departments of General Paediatrics and Immunology, Perth Children's Hospital (P.R.), and Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kid's Institute (P.R.), Perth - all in Australia; the Department of Zoology, University of Oxford, Oxford (J.M.M., M.C.J.M.), the Immunization Department, Public Health England, London (S.N.L., M.E.R., C.T.), the Departments of Pathology and Veterinary Medicine, University of Cambridge, Cambridge (C.T.), the Meningococcal Reference Unit, Public Health England, Manchester (R.B.), and Bristol Children's Vaccine Centre, Schools of Cellular and Molecular Medicine and of Population Health Sciences, University of Bristol, Bristol (A.F.) - all in the United Kingdom; GlaxoSmithKline Vaccines, Amsterdam (J.W.); and GlaxoSmithKline Vaccines, Rockville, MD (K.V.).

Background: The meningococcal group B vaccine 4CMenB is a new, recombinant protein-based vaccine that is licensed to protect against invasive group B meningococcal disease. However, its role in preventing transmission and, therefore, inducing population (herd) protection is uncertain.

Methods: We used cluster randomization to assign, according to school, students in years 10 to 12 (age, 15 to 18 years) in South Australia to receive 4CMenB vaccination either at baseline (intervention) or at 12 months (control). The primary outcome was oropharyngeal carriage of disease-causing (group A, B, C, W, X, or Y) in students in years 10 and 11, as identified by polymerase-chain-reaction assays for (encoding porin protein A) and genogroups. Secondary outcomes included carriage prevalence and acquisition of all and individual disease-causing genogroups. Risk factors for carriage were assessed at baseline.

Results: A total of 237 schools participated. During April through June 2017, a total of 24,269 students in years 10 and 11 and 10,220 students in year 12 were enrolled. At 12 months, there was no difference in the prevalence of carriage of disease-causing between the vaccination group (2.55%; 326 of 12,746) and the control group (2.52%; 291 of 11,523) (adjusted odds ratio, 1.02; 95% confidence interval [CI], 0.80 to 1.31; P = 0.85). There were no significant differences in the secondary carriage outcomes. At baseline, the risk factors for carriage of disease-causing included later year of schooling (adjusted odds ratio for year 12 vs. year 10, 2.75; 95% CI, 2.03 to 3.73), current upper respiratory tract infection (adjusted odds ratio, 1.35; 95% CI, 1.12 to 1.63), cigarette smoking (adjusted odds ratio, 1.91; 95% CI, 1.29 to 2.83), water-pipe smoking (adjusted odds ratio, 1.82; 95% CI, 1.30 to 2.54), attending pubs or clubs (adjusted odds ratio, 1.54; 95% CI, 1.28 to 1.86), and intimate kissing (adjusted odds ratio, 1.65; 95% CI, 1.33 to 2.05). No vaccine safety concerns were identified.

Conclusions: Among Australian adolescents, the 4CMenB vaccine had no discernible effect on the carriage of disease-causing meningococci, including group B. (Funded by GlaxoSmithKline; ClinicalTrials.gov number, NCT03089086.).
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http://dx.doi.org/10.1056/NEJMoa1900236DOI Listing
January 2020

First statewide meningococcal B vaccine program in infants, children and adolescents: evidence for implementation in South Australia.

Med J Aust 2020 02 7;212(2):89-93. Epub 2020 Jan 7.

Communicable Disease Control Branch, Department for Health and Wellbeing, Adelaide, SA.

Invasive meningococcal disease (IMD) is an uncommon but life-threatening infection caused by Neisseria meningitidis. Serogroups B, C, W and Y cause most IMD cases in Australia. The highest incidence occurs in children under 5 years of age. A second peak occurs in adolescents and young adults, which is also the age of highest carriage prevalence of N. meningitidis. Meningococcal serogroup B (MenB) disease predominated nationally before 2016 and has remained the predominant cause of IMD in South Australia with 82% of cases, compared with 35% in New South Wales, 35% in Queensland, 9% in Victoria, 29% in Western Australia and 36% nationally in 2016. MenB vaccination is recommended by the Australian Technical Advisory Group on Immunisation for infants up to 2 years of age and adolescents aged 15-19 years (age 15-24 years for at-risk groups, such as people living in close quarters or smokers), laboratory workers with exposure to N. meningitidis, and Aboriginal and Torres Strait Islander children from age 2 months to 19 years. Due to the epidemiology and disease burden from MenB, a meningococcal B vaccine program has been implemented in South Australia for individuals with age-specific incidence rates higher than the mean rate of 2.8/100 000 population in South Australia in the period 2000-2017, including infants, young children (< 4 years) and adolescents (15-20 years). Program evaluation of vaccine effectiveness against IMD is important. As observational evidence also suggests 4CMenB may have an impact on Neisseria gonorrhoeae with genetic homology between bacterial species, the vaccine impact on gonorrhoea will also be assessed.
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http://dx.doi.org/10.5694/mja2.50481DOI Listing
February 2020

Invasive group A Streptococcus disease in Australian children: 2016 to 2018 - a descriptive cohort study.

BMC Public Health 2019 Dec 30;19(1):1750. Epub 2019 Dec 30.

Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Rd, Parkville, Victoria, 3052, Australia.

Objectives: Invasive group A Streptococcus (iGAS) disease is serious and sometimes life-threatening. The Paediatric Active Enhanced Disease Surveillance (PAEDS) Network collects voluntary notifications from seven major Australian paediatric hospitals on patients with certain conditions, including iGAS disease. Our aims were to: 1) Describe the epidemiological distribution of paediatric iGAS disease in Australia and correlate this with influenza notifications, 2) Identify GAS strains commonly associated with invasive disease in children.

Methods: IGAS and influenza notification data were obtained (from the PAEDS Network and the Australian Institute of Health and Welfare, respectively, for the period 1 July 2016 to 30 June 2018). Included iGAS patients had GAS isolated from a normally sterile body site. Data were described according to selected clinical and demographic characteristics, including by age group and Australian State, with proportions and minimum incidence rates estimated.

Results: A total of 181 patients were identified, with most (115, 63.5%) <5 years old. The mean annual minimum incidence rate was 1.6 (95% confidence interval: 1.1-2.3) per 100,000 children across the study period. An epidemiological correlation with the seasonal burden of influenza was noted. Contact prophylaxis was not consistently offered. Of 96 patients with emm-typing results available, 72.9% showed emm-1, -4 or - 12.

Conclusions: Robust surveillance systems and cohesive patient management guidelines are needed. Making iGAS disease nationally notifiable would help facilitate this. Influenza vaccination may contribute to reducing seasonal increases in iGAS incidence. The burden of disease emphasises the need for ongoing progress in GAS vaccine development.
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http://dx.doi.org/10.1186/s12889-019-8085-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6937995PMC
December 2019

Relationship between birth weight or fetal growth rate and postnatal allergy: A systematic review.

J Allergy Clin Immunol 2019 12 12;144(6):1703-1713. Epub 2019 Oct 12.

Robinson Research Institute, University of Adelaide, Adelaide, Australia; Adelaide Medical School, University of Adelaide, Adelaide, Australia. Electronic address:

Background: Individual susceptibility to allergic diseases is developmentally programmed by early-life exposures. Evidence from preclinical studies suggests that intrauterine growth restriction is protective against later inflammatory responses to allergens.

Objective: We sought to evaluate whether prenatal growth affects susceptibility to allergy in human subjects.

Methods: We systematically searched for relevant studies in 11 databases, including Web of Science, ProQuest, EMBASE, and PubMed. We included only studies that corrected for gestational age or were restricted to full-term infants to separate effects of fetal growth from those of prematurity.

Results: The 42 eligible studies included prospective and retrospective cohort, cross-sectional, and case-control studies. Only 2 studies reported allergic asthma. A birth weight increase of 1 kg was associated with a 44% greater risk of food allergy in children (odds ratio [OR], 1.44; 95% CI, 1.04-1.99; P = .001), a 17% greater risk of ever allergic dermatitis in children (OR, 1.17; 95% CI, 1.04-1.32; P = .008), and a 34% greater risk of ever or current allergic dermatitis in infants up to 2 years of age (OR, 1.34; 95% CI, 1.08-1.68; P = .009). Risks of allergic rhinitis were not associated with birth weight.

Conclusions: The results of these meta-analyses suggest that intrauterine growth restriction protects against allergic diseases in human subjects consistent with preclinical evidence but that effects might differ between allergic diseases. The strongest evidence is available for infancy and early childhood, and additional studies in older children and adults are needed to determine whether the effects of prenatal growth on each allergic disease persist or differ between those with severe and mild phenotypes.
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http://dx.doi.org/10.1016/j.jaci.2019.08.032DOI Listing
December 2019

S. aureus colonization in healthy Australian adults receiving an investigational S. aureus 3-antigen vaccine.

J Infect 2019 12 1;79(6):582-592. Epub 2019 Oct 1.

Pfizer Vaccine Research and Development, Pearl River, NY, USA.

Objectives: Assess Staphylococcus aureus (S. aureus) colonization in healthy Australian adults receiving an investigational S. aureus 3-antigen vaccine (SA3Ag).

Methods: In this phase 1, double-blind, sponsor-unblinded study, participants were randomized to receive a single dose (1 of 3 dose levels) of SA3Ag or placebo and a booster dose or placebo at 6 months. S. aureus isolates from nasal, perineal, and oropharyngeal swabs before and through 12 months post-vaccination were identified.

Results: Baseline S. aureus colonization prevalence was 30.6% (any site), with nasal carriage (27.0%) more common than oropharyngeal/perineal (3.2% each). Following initial vaccination (low-dose: 102; mid-dose: 101; high-dose: 101; placebo: 102) and booster (low-dose: 45; mid-dose: 44; high-dose: 27; placebo: 181), placebo and SA3Ag groups showed similar S. aureus carriage through 12 months. Most colonized participants (74.0%) were colonized by single spa types. Placebo and SA3Ag groups had similar persistence of colonization, with 19.6-30.7% due to single spa types. Acquisition was observed in mid- and high-dose recipients (∼20%) and low-dose and placebo recipients (∼12%). Vaccination resulted in substantial increases in antibodies to all 3 antigens, irrespective of carriage status.

Conclusions: Based on descriptive analyses of this small study, SA3Ag vaccination did not impact S. aureus acquisition or carriage. Carriage status did not impact antibody responses to SA3Ag.
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http://dx.doi.org/10.1016/j.jinf.2019.09.018DOI Listing
December 2019
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