Publications by authors named "Caterina Rizzo"

155 Publications

Biotechnological Agents for Patients With Tumor Necrosis Factor Receptor Associated Periodic Syndrome-Therapeutic Outcome and Predictors of Response: Real-Life Data From the AIDA Network.

Front Med (Lausanne) 2021 8;8:668173. Epub 2021 Jul 8.

Department of Medical Sciences, Surgery and Neurosciences, Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease and Rheumatology-Ophthalmology Collaborative Uveitis Center, University of Siena, Siena, Italy.

To describe the role of biotechnological therapies in patients with tumor necrosis factor receptor associated periodic syndrome (TRAPS) and to identify any predictor of complete response. Clinical, laboratory, and therapeutic data from 44 Caucasian TRAPS patients treated with biologic agents were retrospectively collected in 16 Italian tertiary Centers. A total of 55 biological courses with anakinra ( = 26), canakinumab ( = 16), anti-TNF-α agents ( = 10), and tocilizumab ( = 3) were analyzed. A complete response was observed in 41 (74.5%) cases, a partial response in 9 (16.4%) cases and a treatment failure in 5 (9.1%) cases. The frequency of TRAPS exacerbations was 458.2 flare/100 patients-year during the 12 months prior to the start of biologic treatment and 65.7 flare/100 patients-years during the first 12 months of therapy ( < 0.0001). The median duration of attacks was 5.00 (IQR = 10.50) days at the start of biologics and 1.00 (IQR = 0.00) days at the 12-month assessment ( < 0.0001). Likewise, a significant reduction was observed in the Autoinflammatory Disease Activity Index during the study period ( < 0.0001). A significant corticosteroid sparing effect was observed as early as the first 12 months of treatment both in the number of patients requiring corticosteroids ( = 0.025) and in the dosages employed ( < 0.0001). A significant reduction was identified in the erythrocyte sedimentation rate ( < 0.0001), C reactive protein ( < 0.0001), serum amyloid A ( < 0.0001), and in the 24-h proteinuria dosage during follow-up ( = 0.001). A relapsing-remitting disease course (OR = 0.027, C.I. 0.001-0.841, = 0.040) and the frequency of relapses at the start of biologics (OR = 0.363, C.I. 0.301-0.953, = 0.034) were significantly associated with a complete response. No serious adverse events were observed. Treatment with biologic agents is highly effective in controlling clinical and laboratory TRAPS manifestations. Patients with a relapsing-remitting course and a lower frequency of flares at the start of treatment show more likely a complete response to biologic agents.
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http://dx.doi.org/10.3389/fmed.2021.668173DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8295690PMC
July 2021

Digital surveillance through an online decision support tool for COVID-19 over one year of pandemic in Italy: an observational study.

J Med Internet Res 2021 Jul 18. Epub 2021 Jul 18.

Clinical Pathways and Epidemiology Unit, Bambino Gesù Children's Hospital IRCCS, Rome, IT.

Background: Italy has experienced very severe consequences in terms of hospitalizations and deaths during the COVID-19 pandemic. Online decision support systems and self-triage applications have been used in several settings to supplement recommendations from health authorities to prevent and manage COVID-19. A digital Italian health tech startup developed a non-commercial online decision support system to assist individuals in managing their potential exposure to COVID-19 and interpret their symptoms, with a chat user interface, available since the early phases of the pandemic in Italy.

Objective: To compare the trend of sessions in this online support decision system with that of COVID-19 cases reported by the national health surveillance system in Italy, from February 2020 to March 2021.

Methods: We analyzed the number of sessions by users with a COVID-19 positive contact and by users with symptoms compatible with COVID-19, with the number of cases reported by the National surveillance system. To calculate the distance between the time series, we used the Dynamic Time Warping algorithm. We also applied Symbolic Aggregate approXimation (SAX) encoding to the time series in one-week periods and we calculated the Hamming distance between the SAX strings. We shifted time series of sessions from the online decision support system one week ahead and we measured the improvement in Hamming distance to verify the hypothesis that sessions in the online decision support systems anticipate the trends in cases reported to the official surveillance system.

Results: We analyzed a total of 75,557 sessions in the online decision support system. Among them, 65,207 were sessions by users with symptoms, while 19,062 were by contacts with individuals with COVID-19. The highest number of sessions in the online decision support system was recorded in the early phases of the pandemic. A second peak was observed in October 2020 and a third peak was observed in March 2021, in parallel with the surge of reported cases. Peaks in sessions of the online decision support system preceded the surge of COVID-19 notified cases by approximately one week. The distance between sessions by users with COVID 19 contacts and reported cases calculated by dynamic time warping was 61.23 while the distance with sessions by users with symptoms was 93.72. As the time series of users with a COVID 19 contact was more consistent with the trend of confirmed cases, we applied Symbolic Aggregate approXimation encoding and we measured the Hamming distance between these two time series. After applying a one-week shift, the Hamming distance between the time series of sessions by users with a COVID-19 contact and reported cases improved from 0.49 to 0.46. We repeated the analysis restricting the time window to the time period between July and December 2020. The corresponding Hamming distance was 0.16 before shifting the time series, and improved to 0.08 after the time shift.

Conclusions: Temporal trends in the number of sessions of an online COVID-19 online decision support system may precede the trend of reported COVID-19 cases obtained through traditional surveillance. The trends of sessions by users with a contact with COVID-19 cases may better predict reported cases of COVID-19 than sessions by users with symptoms. Data from online decision support systems may represent a useful information source to supplement traditional surveillance and to support the identification of early warning signals in the COVID-19 pandemic.

Clinicaltrial:
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http://dx.doi.org/10.2196/29556DOI Listing
July 2021

Factors driving choices between types and brands of influenza vaccines in general practice in Austria, Italy, Spain and the UK.

PLoS One 2021 15;16(6):e0252836. Epub 2021 Jun 15.

Centre for Health Economics Research & Modelling Infectious Diseases, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.

Influenza vaccine effectiveness (IVE) assessment is increasingly stratified by vaccine type or brand, such as done by the European network of DRIVE. In 2019/2020, eleven influenza vaccines were licensed in Europe. If more than one vaccine type is recommended or if more than one vaccine brand is available for a specific risk group, it is not clear which factors affect the choice of a specific vaccine (type or brand) by a health practitioner for individual patients. This is important for IVE assessment. A survey tailored to the 2019/20 local vaccine recommendations was conducted among GPs in four European countries (Austria, Italy, Spain, UK) to understand how influenza vaccine is offered to recommended risk groups and, if GPs have a choice between 2 or more vaccines, what factors influence their vaccine choice for patients. Overall, 360 GPs participated. In Austria, Italy and Spain GPs indicated that influenza vaccines are commonly offered when patients present for consultation, whereas in the UK all GPs indicated that all relevant patients are contacted by letter. In Austria and Italy, roughly 80% of GPs had only one vaccine type available for patients <65y. The use of any specific vaccine type in this age group is mostly determined by the availability of specific vaccine type(s) at the clinic. GPs frequently reported availability of more than one vaccine type for patients ≥65y in Austria (45%), Italy (70%) and Spain (79%). In this group, patient characteristics played a role in choice of vaccine, notably older age and presence of (multiple) comorbidities. Knowing that a non-patient related factor usually determines the vaccine type a patient receives in settings where more than one vaccine type is recommended for risk groups <65y, simplifies IVE assessment in this age group. However, patient characteristics need careful consideration when assessing IVE in those ≥65y.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0252836PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8205138PMC
June 2021

Brand-specific influenza vaccine effectiveness estimates during 2019/20 season in Europe - Results from the DRIVE EU study platform.

Vaccine 2021 06 3;39(29):3964-3973. Epub 2021 Jun 3.

P95 Pharmacovigilance and Epidemiology, Leuven, Belgium. Electronic address:

DRIVE (Development of Robust and Innovative Vaccine Effectiveness) is an IMI funded public-private platform that aims to annually estimate brand-specific influenza vaccine effectiveness (IVE), for public health and regulatory purposes. IVE analyses and reporting are conducted by public partners in the consortium. In 2019/20, four primary care-based test-negative design (TND) studies (Austria, England, Italy (n = 2)), eight hospital-based TND studies (Finland, France, Italy, Romania, Spain (n = 4)), and one population-based cohort study (Finland) were conducted. The COVID-19 pandemic affected influenza surveillance in all participating study sites, therefore the study period was truncated on February 29, 2020. Age-stratified (6 m-17y, 18-64y, ≥65y), confounder-adjusted, site-specific adjusted IVE estimates were calculated and pooled through meta-analysis. Parsimonious confounder-adjustment was performed, adjusting the estimates for age, sex and calendar time. TND studies included 3531 cases (351 vaccinated) and 5546 controls (1415 vaccinated) of all ages. IVE estimates were available for 8/11 brands marketed in Europe in 2019. Most children and adults < 64y were captured in primary care setting and the most frequently observed vaccine brand was Vaxigrip Tetra. The estimate against any influenza for Vaxigrip Tetra in primary care setting was 61% (95%CI 38-77) in children and 32% (95%CI -13-59) in adults up to 64y. Most adults ≥ 65y were captured in hospital setting and the most frequently observed brand was Fluad, with an estimate of 52% (95%CI 27-68). The population-based cohort covered 511,854 person-years and two vaccine brands. In children aged 2-6y, the IVE against any influenza was 68% (95%CI 58-75) for Fluenz Tetra and 71% (56-80) for Vaxigrip Tetra. In adults ≥ 65y, IVE against any influenza was 29% (20-36) for Vaxigrip Tetra. DRIVE is a growing platform. Public health institutes with surveillance data and hospitals in countries with high influenza vaccine coverage are encouraged to join DRIVE.
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http://dx.doi.org/10.1016/j.vaccine.2021.05.059DOI Listing
June 2021

Sars-Cov2 Not Detected in a Pediatric Population With Acute Respiratory Infection in Primary Care in Central and Southern Italy From November 2019 to Early March 2020.

Front Pediatr 2021 11;9:620598. Epub 2021 May 11.

Department of Biomedical Science and Human Oncology, University of Bari, Bari, Italy.

In December 2019, a novel coronavirus named SARS-CoV-2 started circulating in China and this led to a major epidemic in Northern Italy between February and May 2020. Young children (aged <5 years) seem to be less affected by this coronavirus disease (COVID-19) compared to adults, although there is very little information on the circulation of this new virus among children in Italy. We retrospectively tested nasopharyngeal swabs for SARS-CoV-2 in samples collected in young children between November, 2019 and March, 2020 in the context of the RSV ComNet study. Two networks of primary care pediatricians in Lazio (Central Italy) and Puglia (Southern Italy) collected nasopharyngeal swabs from children, aged <5 years, presenting with symptoms for an acute respiratory infection (ARI). The RSV ComNet study is a multicenter study implemented to estimate the burden of RSV in young children (aged <5 years) in the community. Swabs were sent to a central reference laboratory and tested for 14 respiratory viruses through RT-PCR. All collected samples were retrospectively tested for SARS-CoV-2 using RT-PCR (Istituto Superiore di Sanità protocol). A total of 293 children with ARI were identified in the two participating networks. The highest number of cases were recruited in weeks 51/2019 and 3/2020. The majority of patients (57%) came from the Lazio region. All of the 293 samples tested negative for SARS-Cov2. Rhinovirus was the most frequently detected virus (44%), followed by RSV (41%) and influenza viruses (14%). Our study shows that in Lazio (a region of intermediate SARS-COV-2 incidence) and Puglia (a region of low incidence), the SARS-Cov2 virus did not circulate in a sample of ARI pediatric cases consulting primary care pediatricians between November 2019 and March 2020.
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http://dx.doi.org/10.3389/fped.2021.620598DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8147864PMC
May 2021

Cytokine expression patterns in hospitalized children with Bordetella pertussis, Rhinovirus or co-infection.

Sci Rep 2021 May 26;11(1):10948. Epub 2021 May 26.

Multifactorial Disease and Complex Phenotype Research Area, Bambino Gesù Children's Hospital (IRCCS), Piazza S. Onofrio, 4, 00165, Rome, Italy.

Mechanisms of interaction between Bordetella pertussis and other viral agents are yet to be fully explored. We studied the inflammatory cytokine expression patterns among children with both viral-bacterial infections. Nasopharyngeal aspirate (NPA) samples were taken from children, aged < 1 year, positive for Rhinovirus, Bordetella pertussis and for Rhinovirus and Bordetella pertussis. Forty cytokines were evaluated in NPA by using human cytokine protein arrays and a quantitative analysis was performed on significantly altered cytokines. Forty cytokines were evaluated in NPA by using human cytokine protein arrays and a quantitative analysis was performed on significantly altered cytokines. Our results show that co-infections display a different inflammatory pattern compared to single infections, suggesting that a chronic inflammation caused by one of the two pathogens could be the trigger for exacerbation in co-infections.
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http://dx.doi.org/10.1038/s41598-021-89538-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8154898PMC
May 2021

Whole Exome Sequencing in BRCA1-2 Candidate Families: The Contribution of Other Cancer Susceptibility Genes.

Front Oncol 2021 7;11:649435. Epub 2021 May 7.

Medical Genetics, University of Siena, Siena, Italy.

Hereditary Breast and Ovarian Cancer (HBOC) syndrome is a condition in which the risk of breast and ovarian cancer is higher than in the general population. The prevalent pathogenesis is attributable to inactivating variants of the highly penetrant genes, however, other cancer susceptibility genes may also be involved. By Whole Exome Sequencing (WES) we analyzed a series of 200 individuals selected for genetic testing in genes according to the updated National Comprehensive Cancer Network (NCCN) guidelines. Analysis by MLPA was performed to detect large deletions/duplications. Focusing on genes, data analysis identified 11 cases with pathogenic variants (4 in and 7 in ) and 12 with uncertain variants (7 in and 5 in ). Only one case was found with a large deletion. Whole exome analysis allowed to characterize pathogenic variants in 21 additional genes: 10 genes more traditionally associated to breast and ovarian cancer (, , , , , , and ) (5% diagnostic yield) and 11 in candidate cancer susceptibility genes (, , , , , , , , and ). In conclusion, this study allowed a personalized risk assessment and clinical surveillance in an increased number of HBOC families and to broaden the spectrum of causative variants also to candidate non-canonical genes.
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http://dx.doi.org/10.3389/fonc.2021.649435DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8139251PMC
May 2021

Acute Kidney Injury in Pediatric Cardiac Intensive Care Children: Not All Admissions Are Equal: A Retrospective Study.

J Cardiothorac Vasc Anesth 2021 Apr 16. Epub 2021 Apr 16.

Department of Pediatrics, Division of Pediatric Cardiology, University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora, CO.

Objectives: To describe the incidence, associated characteristics, and outcomes of the maximum severity of acute kidney injury (AKI) in a heterogeneous population of critically ill children with cardiac disease.

Design: Retrospective cohort study.

Setting: Pediatric cardiac intensive care unit (PCICU).

Participants: Patients admitted to the PCICU.

Interventions: None.

Measurements And Main Results: From January 2018 to July 2020 all patients admitted to a tertiary PCICU were included. Only the first admission was considered. Neonates ≤seven days old were excluded. Of 742 patients, 53 were medical cases, 69 catheterization laboratory cases, and 620 surgical cases (with five subgroups). The median age was 2.47 years (interquartile range [IQR], 0.38-9.85 years), with a median Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery score of 2 (IQR, 1-3). Median PCICU length of stay was three days (IQR, 2-7 days), and 21 (2.8%) patients died. Any incidence of AKI occurred in 70% of patients, 26% of which were classified as mild (stage 1) and 43% as severe (stages 2 and 3). AKI was diagnosed by urine output criteria in 56%, serum creatinine in 28%, and both in 16% of patients. Severe AKI occurred in subgroups as follows: medical (38%), catheterization laboratory (45%), correction (35%), palliation (55%), transplantation (85%), mechanical assistance (70%), and redo surgery (58%). Severe AKI patients were significantly older (p = 0.004), had a higher Pediatric Index of Mortality 3 score (p = 0.0004), had a higher cumulative fluid balance (p < 0.0001), and had a longer cardiopulmonary bypass time (p < 0.0001). Early AKI (≤24 hours from admission) was the most frequent presentation, with a greater proportion of severe cases in the early group compared with the intermediate (>24 and ≤48 hours) and late (>48 hours) (p < 0.0001) groups. Presentation of late severe AKI had a higher mortality (odds ratio, 4.9; 95% confidence interval, 1.8-15; p = 0.001).

Conclusions: Severe AKI occurs in 43% of cardiac children and is diagnosed early, most often by urine output criteria. Severe AKI incidence varies significantly within subgroups of cardiac patients. Late AKI is associated with worse outcomes.
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http://dx.doi.org/10.1053/j.jvca.2021.04.015DOI Listing
April 2021

Knowledge and Perception of COVID-19 Pandemic during the First Wave (Feb-May 2020): A Cross-Sectional Study among Italian Healthcare Workers.

Int J Environ Res Public Health 2021 04 4;18(7). Epub 2021 Apr 4.

Clinical Pathways and Epidemiology, Bambino Gesù Children's Hospital IRCSS, Viale di Villa Pamphili 100, 00152 Rome, Italy.

Italy was the first country in Europe to face the coronavirus pandemic. The aim of the study was to analyze healthcare workers' (HCWs) level of information, practice, and risk perception towards COVID-19. We set up a cross-sectional study through SurveyMonkey and distributed the link through Facebook and Whatsapp closed groups. The research instrument was a 31 items questionnaire distributed using Facebook and Whatsapp. It was conducted in Italy from February to May 2020. The study participants were general practitioners, pediatricians and other health professionals. A total of 958 participants were included: 320 (33.4%) general practitioners, 248 (25.9%) pediatricians and 390 (40.7%) other health professionals. The highest response rate was from Northern Italy (48.1%), followed by Central Italy (29.9%) and Southern Italy (22.0%). Less than a half (46%) of respondents felt they had a good level of information of COVID-19 case definition and of national prevention guidelines. Respondents reported to have changed their clinical practice; particularly, they increased the use of masks (87.1%, < 0.001), disinfection and sanitization of doctors' offices (75.8%, < 0.001), the use of protective glasses (71.2%, < 0.001), alcoholic hand solution (71.2%, < 0.001), and hand washing (31.8%, = 0.028). HCWs are at high risk of infection; less than a half of them felt adequately prepared to face COVID-19 pandemic, so they need extensive information and awareness of the disease to take adequate precautionary measures, and they are crucial to disseminate good practices.
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http://dx.doi.org/10.3390/ijerph18073767DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8038455PMC
April 2021

Deciphering Genetic Variants of Warfarin Metabolism in Children With Ventricular Assist Devices.

Pediatr Cardiol 2021 Jun 10;42(5):1082-1087. Epub 2021 Apr 10.

Heart Failure, Transplant and Mechanical Assistance Program Unit, Bambino Gesù Children Hospital, Rome, Italy.

Warfarin is prescribed in patients with ventricular assist devices (VADs). Dosage depends on several factors including the underlying genotype. These include polymorphisms of genes encoding cytochrome P450 enzymes, the main ones being CYP2C9, VKORC1, and CYP4F2. The objectives of this study were to evaluate the prevalence of CY2CP9 1*2*3*, VKORC1, and CYP4F2 in children with VADs and the time to reach the target international normalized ratio. We performed a retrospective/prospective study in children with VADs. We recorded polymorphisms, disease, type of VAD, ethnicity, age, gender, height, weight, INR values, bleeding, and thromboembolic episodes. Informed consent was obtained. We enrolled 34 children (19 male, 15 female), with a median age of 2 years (range 0.3-17 years) and median weight of 6.9Kg. The Berlin Heart was the most commonly implanted VAD (22/34; 64%), and the most common diagnosis was dilated cardiomyopathy. Statistical analysis confirmed a significant partial correlation with VKORC1 CC (p = 0.019). The CYP2C9*2 CT genotype showed a late rise in target INR values (p = 0.06), while the CYP2C9*2 CC showed a tendency toward an early INR rise (p = 0.024). We provide new information on the contribution of the warfarin polymorphisms in children with VAD implantation. Pharmacogenomic dosing for children using warfarin has the potential to improve clinical care in VAD patients. Patients with the CYP2C9*2 CT genotype may need more time or higher doses to reach target INR, while clinicians may need to be aware of the potential for a rapid rise in INR in patients with the CYP2C9*2 CC genotype.
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http://dx.doi.org/10.1007/s00246-021-02585-2DOI Listing
June 2021

Investigating the procurement system for understanding seasonal influenza vaccine brand availability in Europe.

PLoS One 2021 8;16(4):e0248943. Epub 2021 Apr 8.

Seqirus, Amsterdam, The Netherlands.

Background: Timely knowledge of which influenza vaccine brands are procured and where is of interest to inform site-selection for brand-specific influenza vaccine effectiveness (VE) studies. Vaccine procurement is a key determinant of brand availability. We therefore sought to understand how the procurement for seasonal influenza vaccine in Europe is organized, how this drives brand availability and how procurement data could enable to determine brand availability pre-season.

Methods: Structured telephone interviews were conducted with 15 experts in 16 European countries between 2017 and 2019 to collect information on the influenza vaccine procurement systems. Sources of (brand-specific) procurement data were identified and assessed on public accessibility. Vaccine type and brand availability and timelines were determined for the 2019-20 season to understand how procurement systems drive brand availability and diversity.

Results: Four main types of procurement systems for seasonal influenza vaccination campaigns were identified: national public tenders (Croatia, Denmark, Finland, Ireland, Lithuania, Netherlands, Norway, Scotland, Slovenia), regional public tenders (Italy, Spain, Sweden), direct purchase of vaccines by GPs (England, Wales) or pharmacies (Belgium, France, Germany, Greece) from manufacturers or wholesalers. National public tender outcomes are publicly available and timely; brand availability at clinic level can generally be deduced or narrowed down to two brands. Regional tender outcomes are more difficult to find, known very late or not available. In Italian and Spanish regions tenders may be awarded only a few weeks before the seasonal campaign. No public procurement information is available for countries with direct purchase.

Conclusion: At the country-level, brand diversity is generally lower for countries with national public tenders than for countries with regional public tenders or direct purchase. In only a few countries, procurement data at the brand level is both publicly available and timely. Therefore the usefulness of procurement data for prospective site-selection for brand-specific VE studies is limited.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0248943PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8031425PMC
April 2021

Digital tools, multidisciplinarity and innovation for communicating vaccine safety in the COVID-19 era.

Hum Vaccin Immunother 2021 Mar 25:1-4. Epub 2021 Mar 25.

Multifactorial and Complex Diseases Research Area, Bambino Gesù Children's Hospital, Rome, Italy.

The research on the anti-SARS-CoV-2 vaccines and their commercialization is an opportunity to test and consolidate the current knowledge along with the diverse available tools related to vaccine communication.In this paper we explore the value of a multidisciplinary approach in this field: vaccine communication activities can be combined with insights from data science, risk communication, behavior change, design thinking and digital marketing. Methodologies derived from innovation and human-centered design can contribute to the development and testing of vaccine promotion campaigns, speeding up processes and streamlining the production of evidence in this area. The multiple activities involving the anti-SARS-CoV-2 vaccine could be the fertile ground in which to develop, test and refine effective frameworks to transfer data acquired through listening strategies into effective vaccine promotion campaigns. The World Health Organization's Vaccine Safety Net is an interesting example of trusted information sources that aim toward using digital tools and innovative methodologies for communicating science-based information on vaccine safety at the global level.
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http://dx.doi.org/10.1080/21645515.2020.1865048DOI Listing
March 2021

Digital tools in the informed consent process: a systematic review.

BMC Med Ethics 2021 02 27;22(1):18. Epub 2021 Feb 27.

Ospedale Pediatrico Bambino Gesù (OPBG), Piazza di Sant'Onofrio, 4, 00165, Rome, Italy.

Background: Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients' autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the non-digital Informed Consent process.

Methods: We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio-video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia.

Results: Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia (29/73), non-interactive multimedia (13/73), and videos (31/73), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and clinical research (12/38). For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes.

Conclusions: Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact.
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http://dx.doi.org/10.1186/s12910-021-00585-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7913441PMC
February 2021

IQSEC2 disorder: A new disease entity or a Rett spectrum continuum?

Clin Genet 2021 Mar 9;99(3):462-474. Epub 2021 Jan 9.

Medical Genetics, University of Siena, Siena, Italy.

IQSEC2 mutations are associated with IQSEC2-related intellectual disability (ID). Phenotypic spectrum has been better defined in the last few years by the increasing number of reported cases although the genotype-phenotype relationship for IQSEC2 remains overall complex. As for IQSEC2-related ID a wide phenotypic diversity has been described in Rett syndrome (RTT). Several patients harboring IQSEC2 mutations present with clinical symptoms similar to RTT and some cases meet most of the criteria for classic RTT. With the aim of establishing a genotype-phenotype correlation, we collected data of 16 patients harboring IQSEC2 point mutations (15 of them previously unreported) and of five novel patients carrying CNVs encompassing IQSEC2. Most of our patients surprisingly shared a moderate-to-mild phenotype. The similarities in the clinical course between our mild cases and patients with milder forms of atypical RTT reinforce the hypothesis that also IQSEC2 mutated patients may lay under the wide clinical spectrum of RTT and thus IQSEC2 should be considered in the differential diagnosis. Our data confirm that position, type of variant and gender are crucial for IQSEC2-associated phenotype delineation.
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http://dx.doi.org/10.1111/cge.13908DOI Listing
March 2021

Attitudes and Beliefs on Influenza Vaccination during the COVID-19 Pandemic: Results from a Representative Italian Survey.

Vaccines (Basel) 2020 Nov 30;8(4). Epub 2020 Nov 30.

SWG S.p.A., 34133 Trieste, Italy.

The last 2019/20 northern hemisphere influenza season overlapped with the first wave of coronavirus disease 2019 (COVID-19) pandemic. Italy was the first western country where severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spread to a significant extent. In this representative cross-sectional survey, we aimed to describe some opinions and attitudes of the Italian general population towards both influenza vaccination and the COVID-19 pandemic, and to identify potential modifiers of the decision-making process regarding the uptake of the 2020/21 influenza vaccine. A total of 2543 responses were analyzed. Although most (74.8%) participants valued influenza vaccination positively and declared that it should be mandatory, some misconceptions around influenza persist. The general practitioner was the main source of trusted information on influenza vaccines, while social networks were judged to be the least reliable. Younger and less affluent individuals, subjects not vaccinated in the previous season, and those living in smaller communities showed lower odds of receiving the 2020/21 season influenza vaccination. However, the COVID-19 pandemic may have positively influenced the propensity of being vaccinated against 2020/21 seasonal influenza. In order to increase influenza vaccination coverage rates multidisciplinary targeted interventions are needed. The role of general practitioners remains crucial in increasing influenza vaccine awareness and acceptance by effective counselling.
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http://dx.doi.org/10.3390/vaccines8040711DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7712959PMC
November 2020

One step closer to influenza vaccine inclusiveness.

Pediatr Allergy Immunol 2020 11;31 Suppl 26:69-71

Pediatric Immunopathology and Allergology Unit, University of Rome Tor Vergata, Policlinico Tor Vergata, Rome, Italy.

Flu virus infection is a common cause of acute respiratory illness, with the major incidence in pediatric age, high morbidity, and mortality. The flu vaccine is recommended for all people aged ≥6 months, unless specific contraindications are present. Younger and older age, pregnancy, chronic diseases like asthma, and immunodeficiency are risk factors for severe complications following flu infection. Thus, these categories represent the target for flu vaccine strategies in most countries. Inactivated influenza vaccine (IIV), recombinant influenza vaccine (RIV) or live-attenuated influenza virus (LAIV) are currently available, with specific precautions and contraindications. We aim to resume the current indications for vaccines in the vulnerable populations to support flu vaccination inclusiveness, in anticipation of a "universal vaccine" strategy.
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http://dx.doi.org/10.1111/pai.13338DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7753274PMC
November 2020

Online health information seeking behaviours of parents of children undergoing surgery in a pediatric hospital in Rome, Italy: a survey.

Ital J Pediatr 2020 Sep 29;46(1):141. Epub 2020 Sep 29.

Multifactorial and Complex Diseases Research Area, Bambino Gesù Children's Hospital, Piazza di Sant'Onofrio 4, 00165, Rome, Italy.

Background: People increasingly search online for health information. Particularly, parents of patients often use the Internet as a source for health information. We conducted a survey to investigate the online searching behavior of parents of patients < 18 years, admitted for surgery in an Italian pediatric hospital.

Methods: The cross-sectional survey was nested in a prospective cohort study on surgical procedures. Parents of patients undergoing surgical procedures at Bambino Gesù Children's Hospital, Rome, Italy, were enrolled and contacted by phone after the procedure. We recorded socio-demographic data, sex, length of stay following surgery, proximity of residence to the hospital, use of the internet to search for information on the surgery before and after the intervention and effect of information found online.

Results: The majority (91%) of parents of children undergoing surgical intervention used the internet. Of these, 74.3% of parents searched for information before surgery, and 26.1% searched for information after. Most parents searched for information on the care provider's website. Two thirds of parents reported that information found online had increased their understanding of the child's condition. Multivariate analyses indicated that families living far from the hospital (> 43 km) were more likely to search for health information (OR 2.3; 95% CI 1.34-4.00), as were families of patients undergoing a major surgery (OR = 2.1; 95% CI 1.04-4.11).

Conclusions: Parents of children undergoing surgery often search online for information on their child's intervention, in particular those whose child is scheduled for a major surgery and those living far from the hospital. A survey like the present one allows to understand parents' information needs, to better guide them in online information seeking and to better tailor information provided on the care provider's website.
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http://dx.doi.org/10.1186/s13052-020-00884-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7523374PMC
September 2020

The use of web analytics combined with other data streams for tailoring online vaccine safety information at global level: The Vaccine Safety Net's web analytics project.

Vaccine 2020 09 9;38(41):6418-6426. Epub 2020 Aug 9.

Bambino Gesù Children's Hospital, Rome, Italy.

The Vaccine Safety Net's Web Analytics Project (VSN-WAP) was launched in October 2017 to monitor the behavior of users visiting websites belonging to the VSN, a global network of websites providing science-based information on vaccine safety. Participating websites could provide web metrics in two ways: through a Google Analytics (GA) script, which automatically forwarded metrics to a central account and through manual input (MI) of a reduced subset of metrics (Sessions, Page Views, New Users, Bounce Rate, Views/Session and Average Session Duration), which were pooled with the metrics obtained through GA. Additional metrics were obtained from websites providing data through Google Analytics (Country, Age, Sex, Device). We report results from February 2018 to March 2019. In March 2019, 32 websites were participating in the project (21 through GA, 11 through MI). From February 2018 to March 2019 we recorded 22,471,535 sessions, with 38,307,349 page views. Sessions, New Users and Page views progressively increased, Views/Session, Bounce Rate and Average Session Duration remained stable. Most users were female (68%) and belonged to the 25-34 age range (37%), followed by 35-44 (22%) and 18-24 (19%). Fifty-four percent of users connected from a mobile device, 42% from a desktop and 4% from a tablet. Digital media monitoring techniques can provide insights on the characteristics of users with a specific interest in vaccines. These data can be exploited to improve the performance of websites providing information on vaccines to the general public.
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http://dx.doi.org/10.1016/j.vaccine.2020.07.070DOI Listing
September 2020

Vaccine effectiveness against laboratory-confirmed influenza in Europe - Results from the DRIVE network during season 2018/19.

Vaccine 2020 09 7;38(41):6455-6463. Epub 2020 Aug 7.

P95 Pharmacovigilance and Epidemiology, Leuven, Belgium. Electronic address:

The DRIVE project aims to establish a sustainable network to estimate brand-specific influenza vaccine effectiveness (IVE) annually. DRIVE is a public-private partnership launched in response to EMA guidance that requires effectiveness evaluation from manufacturers for all individual influenza vaccine brands every season. IVE studies are conducted by public partners in DRIVE. Private partners (vaccine manufacturers from the European Federation of Pharmaceutical Industries and Association (EFPIA)) provide written feedback moderated by an independent scientific committee. Test-negative design (TND) case-control studies (4 in primary care and five in hospital) were conducted in six countries in Europe during the 2018/19 season. Site-specific confounder-adjusted vaccine effectiveness (VE) estimates for any vaccine exposure were calculated by age group (<18 years (y), 18-64y and 65 + y) and pooled by setting (primary care, hospital) through random effects meta-analysis. In addition, one population-based cohort study was conducted in Finland. TND studies included 3339 cases and 6012 controls; seven vaccine brands were reported. For ages 65 + y, pooled VE against any influenza strain was estimated at 27% (95%CI 6-44) in hospital setting. Sample size was insufficient for meaningful IVE estimates in other age groups, in the primary care setting, or by vaccine brand. The population-based cohort study included 274,077 vaccinated and 494,337 unvaccinated person-years, two vaccine brands were reported. Brand-specific IVE was estimated for Fluenz Tetra (36% [95%CI 24-45]) for ages 2-6y, Vaxigrip Tetra (54% [43-62]) for ages 6 months to 6y, and Vaxigrip Tetra (30% [25-35]) for ages 65 + y. The results presented are from the second influenza season covered by the DRIVE network. While sample size from the pooled TND studies was still too low for precise (brand-specific) IVE estimates, the network has approximately doubled in size compared to the pilot season. Taking measures to increase sample size is an important focus of DRIVE for the coming years.
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http://dx.doi.org/10.1016/j.vaccine.2020.07.063DOI Listing
September 2020

Moderate Vaccine Effectiveness against Severe Acute Respiratory Infection Caused by A(H1N1)pdm09 Influenza Virus and No Effectiveness against A(H3N2) Influenza Virus in the 2018/2019 Season in Italy.

Vaccines (Basel) 2020 Jul 30;8(3). Epub 2020 Jul 30.

IRCCS, Bambino Gesù Children's Hospital, 00165 Rome, Italy.

Every season, circulating influenza viruses change; therefore, vaccines must be reformulated each year. We aimed to estimate vaccine effectiveness (VE) against severe influenza infection for the 2018/19 season in Italy. We conducted a test-negative design case-control study at five Italian hospitals. We estimated influenza VE against severe acute respiratory infection (SARI) requiring hospitalisation overall, and by virus subtype, vaccine brand, and age. The 2018/19 season was characterised by A(H1N1)pmd09 and A(H3N2) influenza viruses. Vaccine coverage among <18 years recruited SARI cases was very low (3.2%). Seasonal vaccines were moderately effective against type A influenza overall (adjusted VE = 40.5%; 95% confidence interval (CI) = 18.7-56.4%) and subtype A(H1N1)pmd09 viruses (adjusted VE = 55%; 95% CI = 34.5-69.1%), but ineffective against subtype A(H3N2) viruses (adjusted VE = 2.5%; 95% CI = -50.0-36.7%). Both Fluad and Fluarix Tetra vaccines were effective against type A influenza overall and subtype A(H1N1)pdm09 viruses. VE appeared to be similar across age groups (0-64 years, ≥65 years). Seasonal influenza vaccines in the 2018/19 season were moderately effective in preventing SARI caused by A(H1N1)pdm09 influenza but ineffective against A(H3N2).
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http://dx.doi.org/10.3390/vaccines8030427DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7564262PMC
July 2020

A data driven clinical algorithm for differential diagnosis of pertussis and other respiratory infections in infants.

PLoS One 2020 23;15(7):e0236041. Epub 2020 Jul 23.

Predictive and Preventive Medicine Research Unit, Multifactorial and Systemic Diseases Research Area, Bambino Gesù Children's Hospital, Rome, Italy.

Background: Clinical criteria for pertussis diagnosis and clinical case definitions for surveillance are based on a cough lasting two or more weeks. As several pertussis cases seek care earlier, a clinical tool independent of cough duration may support earlier recognition. We developed a data-driven algorithm aimed at predicting a laboratory confirmed pertussis.

Methods: We enrolled children <12 months of age presenting with apnoea, paroxistic cough, whooping, or post-tussive vomiting, irrespective of the duration of cough. Patients underwent a RT-PCR test for pertussis and other viruses. Through a logistic regression model, we identified symptoms associated with laboratory confirmed pertussis. We then developed a predictive decision tree through Quinlan's C4.5 algorithm to predict laboratory confirmed pertussis.

Results: We enrolled 543 children, of which 160 had a positive RT-PCR for pertussis. A suspicion of pertussis by a physician (aOR 5.44) or a blood count showing leukocytosis and lymphocytosis (aOR 4.48) were highly predictive of lab confirmed pertussis. An algorithm including a suspicion of pertussis by a physician, whooping, cyanosis and absence of fever was accurate (79.9%) and specific (94.0%) and had high positive and negative predictive values (PPV 76.3% NPV 80.7%).

Conclusions: An algorithm based on clinical symptoms, not including the duration of cough, is accurate and has high predictive values for lab confirmed pertussis. Such a tool may be useful in low resource settings where lab confirmation is unavailable, to guide differential diagnosis and clinical decisions. Algorithms may also be useful to improve surveillance for pertussis and anticipating classification of cases.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0236041PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7377414PMC
September 2020

Strengthening the Evidence-Based Approach to Guiding Effective Influenza Vaccination Policies.

Vaccines (Basel) 2020 Jun 27;8(3). Epub 2020 Jun 27.

Department of Experimental Medicine, University of Perugia, 06132 Perugia, Italy.

The availability of several effective and safe vaccines enables health systems to counteract annual influenza epidemics. However, the criteria of appropriateness and sustainability require that each citizen should receive the right vaccine. The value of each vaccine can be assessed within well-known frameworks, such as the Health Technology Assessment (HTA), a step that is fundamental to the process of allocating resources to vaccination strategies. The paper describes how HTA has been incorporated as an evidence-based tool to support the definition of Italian vaccination strategies, reports the results of the HTA report on the most recently available influenza vaccine in Italy (cell-based quadrivalent vaccine (QIVc)-Flucelvax Tetra) and elaborates on current and future recommendations in the field of influenza vaccination. Recommendations issued by the Italian Ministry of Health foster the appropriate use of influenza vaccines from 2018-2019 onwards. Evidence of the value of newly available vaccines will hopefully support future decisions and promote the appropriate use of these vaccines on the basis of the characteristics of the target population. However, the success of influenza vaccination will also depend on citizens' empowerment and engagement in the decision-making process.
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http://dx.doi.org/10.3390/vaccines8030342DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7565028PMC
June 2020

AAV-mediated FOXG1 gene editing in human Rett primary cells.

Eur J Hum Genet 2020 10 15;28(10):1446-1458. Epub 2020 Jun 15.

Medical Genetics, University of Siena, Siena, Italy.

Variations in the Forkhead Box G1 (FOXG1) gene cause FOXG1 syndrome spectrum, including the congenital variant of Rett syndrome, characterized by early onset of regression, Rett-like and jerky movements, and cortical visual impairment. Due to the largely unknown pathophysiological mechanisms downstream the impairment of this transcriptional regulator, a specific treatment is not yet available. Since both haploinsufficiency and hyper-expression of FOXG1 cause diseases in humans, we reasoned that adding a gene under nonnative regulatory sequences would be a risky strategy as opposed to a genome editing approach where the mutated gene is reversed into wild-type. Here, we demonstrate that an adeno-associated viruses (AAVs)-coupled CRISPR/Cas9 system is able to target and correct FOXG1 variants in patient-derived fibroblasts, induced Pluripotent Stem Cells (iPSCs) and iPSC-derived neurons. Variant-specific single-guide RNAs (sgRNAs) and donor DNAs have been selected and cloned together with a mCherry/EGFP reporter system. Specific sgRNA recognition sequences were inserted upstream and downstream Cas9 CDS to allow self-cleavage and inactivation. We demonstrated that AAV serotypes vary in transduction efficiency depending on the target cell type, the best being AAV9 in fibroblasts and iPSC-derived neurons, and AAV2 in iPSCs. Next-generation sequencing (NGS) of mCherry/EGFP transfected cells demonstrated that the mutated alleles were repaired with high efficiency (20-35% reversion) and precision both in terms of allelic discrimination and off-target activity. The genome editing strategy tested in this study has proven to precisely repair FOXG1 and delivery through an AAV9-based system represents a step forward toward the development of a therapy for Rett syndrome.
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http://dx.doi.org/10.1038/s41431-020-0652-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7608362PMC
October 2020

Focus on progressive myoclonic epilepsy in Berardinelli-Seip syndrome.

Neurol Sci 2020 Nov 21;41(11):3345-3348. Epub 2020 May 21.

Dipartimento di Medicina Molecolare e dello Sviluppo, Universita' degli Studi di Siena, viale Bracci 16, 53100, Siena, Italy.

Introduction: Berardinelli-Seip syndrome or congenital generalized lipodystrophy type 2 is a rare genetic disorder characterized by selective loss of subcutaneous adipose tissue associated with peripheral insulin resistance and its complications. Nonprogressive mental retardation, dystonia, ataxia, and pyramidal signs are commonly present, whereas epilepsy has only occasionally been observed.

Case Report: We report the case of two sisters, 11 and 18 years old respectively, with an overlapping clinical phenotype compatible with Berardinelli-Seip syndrome and progressive myoclonic epilepsy. Molecular analysis identified an autosomal recessive c.1048C > t;(p(Arg350*)) pathogenic mutation of exon 8 of the BSCL2 gene, which was present in a homozygous state in both patients.

Conclusions: Our paper contributes to further delineate a complex phenotype associated with BSCL2 mutation, underlining how seipin has a central and partially still unknown role that goes beyond adipose tissue metabolism, with a prominent involvement in central nervous system pathology.
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http://dx.doi.org/10.1007/s10072-020-04418-1DOI Listing
November 2020

High rate of HDR in gene editing of p.(Thr158Met) MECP2 mutational hotspot.

Eur J Hum Genet 2020 09 24;28(9):1231-1242. Epub 2020 Apr 24.

Medical Genetics, University of Siena, Siena, Italy.

Rett syndrome is a progressive neurodevelopmental disorder which affects almost exclusively girls, caused by variants in MECP2 gene. Effective therapies for this devastating disorder are not yet available and the need for tight regulation of MECP2 expression for brain to properly function makes gene replacement therapy risky. For this reason, gene editing with CRISPR/Cas9 technology appears as a preferable option for the development of new therapies. To study the disease, we developed and characterized a human neuronal model obtained by genetic reprogramming of patient-derived primary fibroblasts into induced Pluripotent Stem Cells. This cellular model represents an important source for our studies, aiming to correct MECP2 variants in neurons which represent the primarily affected cell type. We engineered a gene editing toolkit composed by a two-plasmid system to correct a hotspot missense variant in MECP2, c.473 C > T (p.(Thr158Met)). The first construct expresses the variant-specific sgRNA and the Donor DNA along with a fluorescent reporter system. The second construct brings Cas9 and targets for auto-cleaving, to avoid long-term Cas9 expression. NGS analysis on sorted cells from four independent patients demonstrated an exceptionally high editing efficiency, with up to 80% of HDR and less than 1% of indels in all patients, outlining the relevant potentiality of the approach for Rett syndrome therapy.
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http://dx.doi.org/10.1038/s41431-020-0624-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7609331PMC
September 2020

How do Twitter users react to TV broadcasts dedicated to vaccines in Italy?

Eur J Public Health 2020 06;30(3):510-515

Predictive and Preventive Medicine Research Unit, Multifactorial and Complex Disease Research Area, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.

Background: Social media monitoring during TV broadcasts dedicated to vaccines can provide information on vaccine confidence. We analyzed the sentiment of tweets published in reaction to two TV broadcasts in Italy dedicated to vaccines, one based on scientific evidence [Presadiretta (PD)] and one including anti-vaccine personalities [Virus (VS)].

Methods: Tweets about vaccines published in an 8-day period centred on each of the two TV broadcasts were classified by sentiment. Differences in tweets' and users' characteristics between the two broadcasts were tested through Poisson, quasi-Poisson or logistic univariate regression. We investigated the association between users' characteristics and sentiment through univariate quasi-binomial logistic regression.

Results: We downloaded 12 180 tweets pertinent to vaccines, published by 5447 users; 276 users tweeted during both broadcasts. Sentiment was positive in 50.4% of tweets, negative in 37.7% and neutral in 10.1% (remaining tweets were unclear or questions). The positive/negative ratio was higher for VS compared to PD (6.96 vs. 4.24, P<0.001). Positive sentiment was associated to the user's number of followers (OR 1.68, P<0.001), friends (OR 1.83, P<0.001) and published tweets (OR 1.46, P<0.001) and to being a recurrent user (OR 3.26, P<0.001).

Conclusions: Twitter users were highly reactive to TV broadcasts dedicated to vaccines. Sentiment was mainly positive, especially among very active users. Displaying anti-vaccine positions on TV elicited a positive sentiment on Twitter. Listening to social media during TV shows dedicated to vaccines can provide a diverse set of data that can be exploited by public health institutions to inform tailored vaccine communication initiatives.
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http://dx.doi.org/10.1093/eurpub/ckaa022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7292342PMC
June 2020

Co-circulation of the two influenza B lineages during 13 consecutive influenza surveillance seasons in Italy, 2004-2017.

BMC Infect Dis 2019 Nov 21;19(1):990. Epub 2019 Nov 21.

Department of Infectious Diseases, Istituto Superiore di Sanità (ISS), Viale Regina Elena 299, Rome, Italy.

Background: Since 1985, two antigenically distinct lineages of influenza B viruses (Victoria-like and Yamagata-like) have circulated globally. Trivalent seasonal influenza vaccines contain two circulating influenza A strains but a single B strain and thus provide limited immunity against circulating B strains of the lineage not included in the vaccine. In this study, we describe the characteristics of influenza B viruses that caused respiratory illness in the population in Italy over 13 consecutive seasons of virological surveillance, and the match between the predominant influenza B lineage and the vaccine B lineage, in each season.

Methods: From 2004 to 2017, 26,886 laboratory-confirmed influenza cases were registered in Italy, of which 18.7% were type B. Among them, the lineage of 2465 strains (49%) was retrieved or characterized in this study by a real-time RT-PCR assay and/or sequencing of the hemagglutinin (HA) gene.

Results: Co-circulation of both B lineages was observed each season, although in different proportions every year. Overall, viruses of B/Victoria and B/Yamagata lineages caused 53.3 and 46.7% of influenza B infections, respectively. A higher proportion of infections with both lineages was detected in children, and there was a declining frequency of B/Victoria detections with age. A mismatch between the vaccine and the predominant influenza B lineage occurred in eight out of thirteen influenza seasons under study. Considering the seasons when B accounted for > 20% of all laboratory-confirmed influenza cases, a mismatch was observed in four out of six seasons. Phylogenetic analysis of the HA1 domain confirmed the co-circulation of both lineages and revealed a mixed circulation of distinct evolutionary viral variants, with different levels of match to the vaccine strains.

Conclusions: This study contributes to the understanding of the circulation of influenza B viruses in Italy. We found a continuous co-circulation of both B lineages in the period 2004-2017, and determined that children were particularly vulnerable to Victoria-lineage influenza B virus infections. An influenza B lineage mismatch with the trivalent vaccine occurred in about two-thirds of cases.
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http://dx.doi.org/10.1186/s12879-019-4621-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6873537PMC
November 2019

Effectiveness of influenza vaccine against influenza A in Europe in seasons of different A(H1N1)pdm09 and the same A(H3N2) vaccine components (2016-17 and 2017-18).

Vaccine X 2019 Dec 17;3:100042. Epub 2019 Sep 17.

Epidemiology Department, Epiconcept, 47 rue de Charenton, 75012 Paris, France.

Introduction: Influenza A(H3N2) viruses predominated in Europe in 2016-17. In 2017-18 A(H3N2) and A(H1N1)pdm09 viruses co-circulated. The A(H3N2) vaccine component was the same in both seasons; while the A(H1N1)pdm09 component changed in 2017-18. In both seasons, vaccine seed A(H3N2) viruses developed adaptations/alterations during propagation in eggs, impacting antigenicity.

Methods: We used the test-negative design in a multicentre primary care case-control study in 12 European countries to measure 2016-17 and 2017-18 influenza vaccine effectiveness (VE) against laboratory-confirmed influenza A(H1N1)pdm09 and A(H3N2) overall and by age group.

Results: During the 2017-18 season, the overall VE against influenza A(H1N1)pdm09 was 59% (95% CI: 47-69). Among those aged 0-14, 15-64 and ≥65 years, VE against A(H1N1)pdm09 was 64% (95% CI: 37-79), 50% (95% CI: 28-66) and 66% (95% CI: 42-80), respectively. Overall VE against influenza A(H3N2) was 28% (95% CI: 17-38) in 2016-17 and 13% (95% CI: -15 to 34) in 2017-18. Among 0-14-year-olds VE against A(H3N2) was 28% (95%CI: -10 to 53) and 29% (95% CI: -87 to 73), among 15-64-year-olds 34% (95% CI: 18-46) and 33% (95% CI: -3 to 56) and among those aged ≥65 years 15% (95% CI: -10 to 34) and -9% (95% CI: -74 to 32) in 2016-17 and 2017-18, respectively.

Conclusions: Our study suggests the new A(H1N1)pdm09 vaccine component conferred good protection against circulating strains, while VE against A(H3N2) was <35% in 2016-17 and 2017-18. The egg propagation derived antigenic mismatch of the vaccine seed virus with circulating strains may have contributed to this low effectiveness. A(H3N2) seed viruses for vaccines in subsequent seasons may be subject to the same adaptations; in years with lower than expected VE, recommendations of preventive measures other than vaccination should be given in a timely manner.
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http://dx.doi.org/10.1016/j.jvacx.2019.100042DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6807025PMC
December 2019
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