Publications by authors named "Rodrigo DeAntonio"

41 Publications

Incidence of dengue illness in Mexican people aged 6 months to 50 years old: A prospective cohort study conducted in Jalisco.

PLoS One 2021 5;16(5):e0250253. Epub 2021 May 5.

Vaccines, GSK, Rockville, Maryland, United States of America.

Background And Objectives: The burden of dengue virus (DENV), a mosquito-borne pathogen, remains difficult to assess due to misdiagnosis and underreporting. Moreover, the large proportion of asymptomatic dengue cases impairs comprehensive assessment of its epidemiology even where effective surveillance systems are in place. We conducted a prospective community-based study to assess the incidence of symptomatic dengue cases in Zapopan and neighboring municipalities in the state of Jalisco, Mexico.

Methods: Healthy subjects aged 6 months to 50 years living in households located in the Zapopan and neighboring municipalities were enrolled for a 24-month follow-up study (NCT02766088). Serostatus was determined at enrolment and weekly contacts were conducted via phone calls and home visits. Participants had to report any febrile episode lasting for at least two days. Suspected dengue cases were tested by reverse-transcriptase quantitative polymerase chain reaction (RT-qPCR), detection of non-structural protein 1 (NS1), anti-DENV immunoglobulin G and M (IgG and IgM) assays.

Results: A total of 350 individuals from 87 households were enrolled. The overall seroprevalence of anti-DENV IgG at enrolment was 19.4% (95% confidence interval [CI] 14.5-25.6) with the highest seroprevalence rate observed in the adult group. Over the 27-month study period from July 2016 to September 2018, a total of 18 suspected dengue cases were reported. Four cases were confirmed by RT-qPCR and serotyped as DENV-1. A fifth case was confirmed by the NS1 assay. The 13 remaining suspected cases were tested negative by these assays. Based on the 5 virologically confirmed cases, symptomatic dengue incidence proportion of 1.4% (95%CI 0.5-3.8) was estimated. No severe cases or hospitalizations occurred during the study.

Conclusion: Community-based active surveillance was shown as efficient to detect symptomatic dengue cases.

Clinical Trial Registration: NCT02766088.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0250253PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099064PMC
May 2021

Performance of a Point of Care Test for Detecting IgM and IgG Antibodies Against SARS-CoV-2 and Seroprevalence in Blood Donors and Health Care Workers in Panama.

Front Med (Lausanne) 2021 2;8:616106. Epub 2021 Mar 2.

Servicio de Hematología. Complejo Hospitalario Metropolitano Dr. Arnulfo Arias Madrid, Caja de Seguro Social, Panama City, Panama.

Novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiologic agent of the ongoing coronavirus disease 2019 (COVID-19) pandemic, which has reached 28 million cases worldwide in 1 year. The serological detection of antibodies against the virus will play a pivotal role in complementing molecular tests to improve diagnostic accuracy, contact tracing, vaccine efficacy testing, and seroprevalence surveillance. Here, we aimed first to evaluate a lateral flow assay's ability to identify specific IgM and IgG antibodies against SARS-CoV-2 and second, to report the seroprevalence estimates of these antibodies among health care workers and healthy volunteer blood donors in Panama. We recruited study participants between April 30th and July 7th, 2020. For the test validation and performance evaluation, we analyzed serum samples from participants with clinical symptoms and confirmed positive RT-PCR for SARS-CoV-2, and a set of pre-pandemic serum samples. We used two by two table analysis to determine the test positive and negative percentage agreement as well as the Kappa agreement value with a 95% confidence interval. Then, we used the lateral flow assay to determine seroprevalence among serum samples from COVID-19 patients, potentially exposed health care workers, and healthy volunteer donors. Our results show this assay reached a positive percent agreement of 97.2% (95% CI 84.2-100.0%) for detecting both IgM and IgG. The assay showed a Kappa of 0.898 (95%CI 0.811-0.985) and 0.918 (95% CI 0.839-0.997) for IgM and IgG, respectively. The evaluation of serum samples from hospitalized COVID-19 patients indicates a correlation between test sensitivity and the number of days since symptom onset; the highest positive percent agreement [87% (95% CI 67.0-96.3%)] was observed at ≥15 days post-symptom onset (PSO). We found an overall antibody seroprevalence of 11.6% (95% CI 8.5-15.8%) among both health care workers and healthy blood donors. Our findings suggest this lateral flow assay could contribute significantly to implementing seroprevalence testing in locations with active community transmission of SARS-CoV-2.
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http://dx.doi.org/10.3389/fmed.2021.616106DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7968482PMC
March 2021

Impact after 10-year use of pneumococcal conjugate vaccine in the Brazilian national immunization program: an updated systematic literature review from 2015 to 2020.

Hum Vaccin Immunother 2021 Mar 18:1-17. Epub 2021 Mar 18.

Instituto Nacional de Cardiologia, Rio de Janeiro, Brasil.

In 2010, a 10-valent pneumococcal non-typeable protein D conjugate vaccine (PHiD-CV) was introduced in the Brazilian national immunization program; the 3 + 1 dose schedule was replaced by a 2 + 1 dose schedule in 2016. This systematic review presents the latest published evidence (2015-2020) on the impact after 10-year use of PHiD-CV in Brazil from a total of 29 publications. Overall, the PHiD-CV program had a positive impact on the morbidity and mortality associated with invasive pneumococcal disease (IPD), pneumonia and acute otitis media (AOM) in children <5 years-old. A reduction in the vaccine-type invasive disease was observed in all-ages; suggesting indirect protection unvaccinated older children and adults. The occurrence of non-vaccine type disease was evidenced in some studies. Higher vaccination coverage is required at national and state level for sustained population impact. Given the change in the vaccination schedule and the dynamics of pneumococcal disease epidemiology, continuous surveillance is warranted.GSK Study identifier: HO-18-19438.
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http://dx.doi.org/10.1080/21645515.2021.1879578DOI Listing
March 2021

Safety and immunogenicity of two novel type 2 oral poliovirus vaccine candidates compared with a monovalent type 2 oral poliovirus vaccine in children and infants: two clinical trials.

Lancet 2021 01 9;397(10268):27-38. Epub 2020 Dec 9.

Fighting Infectious Diseases in Emerging Countries, Miami, FL, USA. Electronic address:

Background: Continued emergence and spread of circulating vaccine-derived type 2 polioviruses and vaccine-associated paralytic poliomyelitis from Sabin oral poliovirus vaccines (OPVs) has stimulated development of two novel type 2 OPV candidates (OPV2-c1 and OPV2-c2) designed to have similar immunogenicity, improved genetic stability, and less potential to reacquire neurovirulence. We aimed to assess safety and immunogenicity of the two novel OPV candidates compared with a monovalent Sabin OPV in children and infants.

Methods: We did two single-centre, multi-site, partly-masked, randomised trials in healthy cohorts of children (aged 1-4 years) and infants (aged 18-22 weeks) in Panama: a control phase 4 study with monovalent Sabin OPV2 before global cessation of monovalent OPV2 use, and a phase 2 study with low and high doses of two novel OPV2 candidates. All participants received one OPV2 vaccination and subsets received two doses 28 days apart. Parents reported solicited and unsolicited adverse events. Type 2 poliovirus neutralising antibodies were measured at days 0, 7, 28, and 56, and stool viral shedding was assessed up to 28 days post-vaccination. Primary objectives were to assess safety in all participants and non-inferiority of novel OPV2 day 28 seroprotection versus monovalent OPV2 in infants (non-inferiority margin 10%). These studies were registered with ClinicalTrials.gov, NCT02521974 and NCT03554798.

Findings: The control study took place between Oct 23, 2015, and April 29, 2016, and the subsequent phase 2 study between Sept 19, 2018, and Sept 30, 2019. 150 children (50 in the control study and 100 of 129 assessed for eligibility in the novel OPV2 study) and 684 infants (110 of 114 assessed for eligibility in the control study and 574 of 684 assessed for eligibility in the novel OPV2 study) were enrolled and received at least one study vaccination. Vaccinations were safe and well tolerated with no causally associated serious adverse events or important medical events in any group. Solicited and unsolicited adverse events were overwhelmingly mild or moderate irrespective of vaccine or dose. Nearly all children were seroprotected at baseline, indicating high baseline immunity. In children, the seroprotection rate 28 days after one dose was 100% for monovalent OPV2 and both novel OPV2 candidates. In infants at day 28, 91 (94% [95% CI 87-98]) of 97 were seroprotected after receiving monovalent OPV2, 134 (94% [88-97]) of 143 after high-dose novel OPV2-c1, 122 (93% [87-97]) of 131 after low-dose novel OPV2-c1, 138 (95% [90-98]) of 146 after high-dose novel OPV2-c2, and 115 (91% [84-95]) of 127 after low-dose novel OPV2-c2. Non-inferiority was shown for low-dose and high-dose novel OPV2-c1 and high-dose novel OPV2-c2 despite monovalent OPV2 recipients having higher baseline immunity.

Interpretation: Both novel OPV2 candidates were safe, well tolerated, and immunogenic in children and infants. Novel OPV2 could be an important addition to our resources against poliovirus given the current epidemiological situation.

Funding: Fighting Infectious Diseases in Emerging Countries and Bill & Melinda Gates Foundation.
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http://dx.doi.org/10.1016/S0140-6736(20)32540-XDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7811205PMC
January 2021

Hepatitis A antibody persistence 8 and 10 years after 1-dose and 2-dose vaccination in children from Panama.

Vaccine 2021 01 22;39(1):26-34. Epub 2020 Nov 22.

GSK, Italy. Electronic address:

Background: Hepatitis A virus (HAV) remains a global public health concern, which is potentially growing in Latin America, due to an expected shift from high to intermediate endemicity levels. The use of HAV vaccines in pediatric national immunization programs (NIPs), either as a 2-dose or a 1-dose schedule, has been explored in Latin American countries; however, evidence demonstrating long-term protection in this population is limited in the region. We evaluated long-term antibody persistence following a 1-dose partial series and the recommended 2-dose schedule used in Panama's pediatric NIP.

Methods: Two independent cross-sectional serological surveys were conducted at year 8 (Y8) and Y10 following vaccination under the NIP with 1 or 2 doses of an inactivated HAV vaccine (Havrix, GSK). Seropositivity (anti-HAV antibody concentration ≥ 15 mIU/mL) rates and antibody geometric mean concentrations (GMCs) were assessed at each serosurvey. Non-inferiority of 1 dose versus 2 doses was also explored.

Results: This study (NCT02712359) included 600 and 599 children at Y8 and Y10 post-vaccination, respectively. Seropositivity rates were 74.3% (95% confidence interval [CI]: 69.0; 79.2) and 97.7% (95% CI: 95.3; 99.1) at Y8 and 71.9% (95% CI: 66.4; 76.9) and 96.3% (95% CI: 93.5; 98.2) at Y10, in the 1-dose and 2-dose groups, respectively. Antibody GMCs were lower in the 1-dose versus the 2-dose group in both surveys. Non-inferiority was not demonstrated since the lower limit of the 2-sided 95% CI for the between-group difference in seropositivity rates (1-dose minus 2-dose) was < -10%.

Conclusion: Anti-HAV antibody persistence was observed in lower percentages of children receiving 1 dose versus 2 doses of Havrix, at 8 and 10 years post-vaccination in Panama. Further investigations are needed to confirm antibody persistence and conclude on the protection afforded beyond 10 years in the pediatric population in Latin America.
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http://dx.doi.org/10.1016/j.vaccine.2020.11.030DOI Listing
January 2021

Incidence and mortality of pertussis disease in infants <12 months of age following introduction of pertussis maternal universal mass vaccination in Bogotá, Colombia.

Vaccine 2020 10 2;38(46):7384-7392. Epub 2020 Oct 2.

GSK, Epidemiology and Health Outcomes Latin America & the Caribbean, Panama City, Panama. Electronic address:

Background: Maternal immunization with tetanus, diphtheria, and acellular pertussis (Tdap) vaccine confers protection to young infants. We aimed to describe trends in pertussis incidence and associated mortality in children aged <12 months before and after introduction of maternal Tdap immunization in Bogotá, Colombia.

Methods: Data on pertussis-related cases/deaths in infants aged <12 months were collected from SIVIGILA for the period 2005-2016, and compared incidence for the pre-vaccine introduction (2005-2012) and post-maternal Tdap vaccination (2014-2016) periods in infants aged <12 months and in three distinct age-strata; ≤6 weeks, 7-<28 weeks, and 28-52 weeks. Mortality comparisons were performed in all infants <12 months.

Results: From 2005 to 2016, 2315 laboratory or clinically-confirmed pertussis cases were reported in infants <12 months of age (278 cases in young infants aged ≤6 weeks); 55 pertussis deaths were reported in children aged <12 months. No pertussis deaths were reported in the 2014-2016 period. Since maternal Tdap introduction in 2013, a consistent decline in pertussis incidence and mortality was observed. In the time-series analysis, incidence declined from 209.4/100,000 persons (2005-2012) to 49.1/100,000 persons (2014-2016) in all children <12 months; a 87.5% (95%CI: 77.2-93.2%) reduction. For these same period's incidence in young infants ≤6 weeks declined from 196.7 to 89.6/100,000 person-years (an 54.4% [95% CI: 35.4-67.9%] reduction). Greater incidence reductions were observed in older infants; 73.4% (95% CI: 68.4-77.6%) in those aged 7-<28 weeks, and 100% in those aged 28-52 weeks. A 100% reduction in Pertussis mortality in infants <12 months was observed. Since Tdap introduction, maternal vaccine coverage rose from <60% in 2013-2015 to 80% in 2016.

Conclusions: Implementation of maternal immunization in Bogotá may have contributed to the reduction in pertussis incidence and mortality among infants <12 months of age (ClinicalTrials.gov: NCT02569879). An Audio Summary linked to this article that can be found on Figshare https://doi.org/10.6084/m9.figshare.12943316.
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http://dx.doi.org/10.1016/j.vaccine.2020.07.046DOI Listing
October 2020

Trends in all-cause pneumonia and otitis media in children aged <2 years following pneumococcal conjugate vaccine introduction in Colombia.

Hum Vaccin Immunother 2021 Apr 23;17(4):1173-1180. Epub 2020 Sep 23.

Vaccines, GSK, Panama City, Panama.

In Colombia, pneumococcal conjugate vaccines (PCVs) were implemented into the infant universal mass vaccination program in a stepwise manner; PCV-7 between 2009 and 2011 in different geographic regions/cities, with nationwide introduction of a 10-valent vaccine (PHiD-CV) in 2012. We aimed to describe trends in all-cause pneumonia mortality and overall mortality, and in the incidence of all-cause pneumonia and otitis media (OM) in Colombian children <2 y (y = years) of age, before and after PCV introduction. We obtained mortality and incidence data, nationally and for five major cities (Bogota, Medellin, Barranquilla, Cali and Cartagena) from 2005-2016 and 2008-2016, respectively, comparing mortality and incidence proportions in the post-PCV introduction period with those in the pre-PCV period. Overall mean reductions in all-cause pneumonia mortality was observed in the post-PCV period nationally (48.8%; 95%CI: 45.5-51.8%) and in four cities including Bogota (77.1%; 71.1-81.8%) and Medellin (56.4%; 44.1-65.9%); no substantial reduction was observed in Cartagena. Similar findings were observed for overall mortality. Reductions in all-cause pneumonia incidence were observed in Bogota (66.0%; 65.5-66.6%), Medellin (40.6%; 39.3-41.9%) and Cartagena (15.0%; 11.2-18.6%), while incidence increased in Barranquilla (78.5%; 68.4-89.2%) and Cali (125.5%; 119.2-132.0%). All-cause OM incidence fell in Medellin and Bogota (42.1-51.1%) but increased (95.8%) in Barranquilla. In conclusion, overall reductions in disease outcomes were observed following PCV introduction in most cities and nationwide. Decreasing trends in outcomes were observed prior to PCV introduction, and limited data points and data reporting issues may have influenced our results. (ClinicalTrials.gov: NCT02567747).
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http://dx.doi.org/10.1080/21645515.2020.1805990DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8018459PMC
April 2021

Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2-17 years: a randomised, placebo-controlled, phase 2 trial.

Lancet 2020 05 17;395(10234):1434-1443. Epub 2020 Mar 17.

Takeda Vaccines, Cambridge, MA, USA.

Background: An unmet clinical need remains for an effective tetravalent dengue vaccine suitable for all age groups, regardless of serostatus. We assessed the immunogenicity and safety of three different dose schedules of a tetravalent dengue vaccine (TAK-003) over a 48-month period in children living in dengue-endemic countries.

Methods: We did a large, phase 2, double-blind, placebo-controlled trial at three sites in the Dominican Republic, Panama, and the Philippines. Healthy participants aged 2-17 years were randomly assigned 1:2:5:1 using an interactive web response system with stratification by age to receive either a two-dose primary series (days 1 and 91), one primary dose (day 1), one primary dose plus booster (days 1 and 365), or placebo. Participants and relevant study personnel were masked to the random assignment until completion of the study at month 48. To maintain masking, TAK-003 recipients were administered placebo doses when appropriate. The primary objective was assessment of neutralising geometric mean titres for each serotype to month 48 assessed in the per-protocol immunogenicity subset. Secondary safety endpoints included proportions of participants with serious adverse events and symptomatic virologically confirmed dengue. This study is registered with ClinicalTrials.gov, NCT02302066.

Findings: Between Dec 5, 2014, and Feb 13, 2015, 1800 children were randomly assigned to the following groups: two-dose primary series (n=201), one primary dose (n=398), one primary dose plus 1-year booster (n=1002), and placebo (n=199). Of them, 1479 (82%) participants completed the 48-month study. Immunogenicity endpoints were assessed in 562 participants enrolled in the immunogenicity subset, of whom 509 were included in the per-protocol subset. At month 48, antibody titres remained elevated in all TAK-003 groups compared with placebo, irrespective of baseline serostatus. At month 48, geometric mean titres were 378 (95% CI 226-632) in two-dose, 421 (285-622) in one-dose, 719 (538-960) in one-dose plus 1-year booster, and 100 (50-201) in placebo recipients against DENV 1; 1052 (732-1511), 1319 (970-1794), 1200 (927-1553), and 208 (99-437) against DENV 2; 183 (113-298), 201 (135-298), 288 (211-392), and 71 (37-139) against DENV 3; and 152 (97-239), 164 (114-236), 219 (165-290), and 46 (26-82) against DENV 4; and tetravalent seropositivity rate was 89% (79-96), 86% (80-92), 97% (93-99), and 60% (47-72), respectively. Virologically confirmed dengue was recorded in 37 (2%) TAK-003 and 13 (7%) placebo participants, with a relative risk of 0·35 (0·19-0·65). No vaccine-related serious adverse events or severe dengue virus disease were reported.

Interpretation: TAK-003 elicited antibody responses against all four serotypes, which persisted to 48 months post-vaccination, regardless of baseline serostatus. No important safety risks were identified. We observed a long-term reduction in risk of symptomatic dengue virus disease in vaccinees. Results from this study provide a long-term safety database and support assessment of the vaccine in the ongoing phase 3 efficacy study.

Funding: Takeda Vaccines.
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http://dx.doi.org/10.1016/S0140-6736(20)30556-0DOI Listing
May 2020

How to assess for the full economic value of vaccines? From past to present, drawing lessons for the future.

J Mark Access Health Policy 2020 31;8(1):1719588. Epub 2020 Jan 31.

Regional Health Outcomes, GSK, Singapore, Singapore.

Cost-effectiveness analysis (CEA) is the economic analysis method most commonly applied today in the context of replacing one treatment with a new one in a developed healthcare system to improve efficiency. CEA is often requested by local healthcare decision-makers to grant reimbursement. New preventative interventions, such as new vaccines, may however have much wider benefits inside and outside healthcare, when compared with treatment. These additional benefits include externalities on indirect clinical impact, reallocation of specific healthcare resources, improved quality of care, better productivity, better disease control, better fiscal revenues, and others. But these effects are sometimes difficult to integrate into a meaningful CEA result. They may appear as specific benefits for specific stakeholders, other than the stakeholders in healthcare. Based on a historical view about the application of economic assessments for vaccines our objective has been to make the inventory of who was/is interested in knowing the economic value of vaccines, in what those different stakeholders are likely to see the benefit from their perspective and how  were/are we able to measure those benefits and to report them well. The historical view disclosed a limited interest in the economic assessment of vaccines at start, more than 50 years ago, that was comparable to the assessment of looking for more efficiency in new industries through optimization exercises. Today, we are exposed to a very rich panoply of different stakeholders (n= 16). They have their specific interest in many different facets of the vaccine benefit of which some are well known in the conventional economic analysis (n=9), but most outcomes are hidden and not enough evaluated and reported (n=26). Meanwhile we discovered that many different methods of evaluation have been explored to facilitate the measurement and reporting of the benefits (n=18). Our recommendation for future economic evaluations of new vaccines is therefore to find the right combination among the three entities of stakeholder type selection, outcome measure of interest for each stakeholder, and the right method to apply. We present at the end examples that illustrate how successful this approach can be.
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http://dx.doi.org/10.1080/20016689.2020.1719588DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034472PMC
January 2020

Barriers to vaccination in Latin America: A systematic literature review.

Vaccine 2020 01 22;38(3):470-481. Epub 2019 Nov 22.

GSK Panama, Ciudad del Saber, Edificio 230, Panama City, Panama. Electronic address:

Current vaccination coverage rates in Latin America and the Caribbean (LAC) are lower than the region-wide rates set by the Pan American Health Organization. To improve vaccination uptake, it is crucial to identify barriers to vaccination. We conducted a systematic literature review to identify the key barriers to vaccination in the LAC region, and to classify and quantify factors affecting vaccination coverage using the barrier categories outlined by the Strategic Advisory Group of Experts (SAGE) working group. We mapped knowledge gaps in the understanding of region-specific and population-specific vaccine hesitancy. Nine databases (Medline via PubMed, Web of Science, LILACS, MedCarib, SciELO, Scopus, PATH, SAGE Online and Google Scholar) were searched for articles published in English, Spanish and Portuguese up to 15 July 2017. A total of 6867 articles were identified of which 75 were included in the review. Majority of the articles were quantitative in nature and nearly half from Brazil. Many other countries in LAC have limited published evidence on barriers to vaccination. The most commonly investigated target population was parents (of children <8 years of age [yoa] and adolescents 9-10 yoa) but there was a balance in the number of publications that reported on influenza, childhood and human papillomavirus vaccination. There was limited direct evidence which reported insights on the new generation of childhood vaccines (pneumococcal or meningococcal vaccines) or studies targeting adolescents and pregnant women. Among the SAGE barrier categories, 'individual/group influences' were the most frequently reported barrier category (68%) followed by 'contextual influences' (47%). Adverse socioeconomic factors, a low level of education, lack of awareness of diseases and their vaccines, religious and cultural beliefs are commonly cited as obstacles to vaccination acceptance. Additional evidence is needed to fully understand the barriers to vaccination for different target populations, countries in the region and specific vaccine types.
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http://dx.doi.org/10.1016/j.vaccine.2019.10.088DOI Listing
January 2020

Interchangeability between pneumococcal conjugate vaccines for pediatric use: a systematic literature review.

Expert Rev Vaccines 2020 11 21;19(11):1011-1022. Epub 2019 Nov 21.

GSK , Wavre, Belgium.

: Evidence on the interchangeability between the two pediatric pneumococcal conjugate vaccines (PCVs) - pneumococcal non-typeable protein D-conjugate vaccine (PHiD-CV) and 13-valent PCV (PCV13) - is limited but growing. We performed a systematic literature review to summarize evidence for PHiD-CV/PCV13 interchangeability regarding immunogenicity, safety, and effectiveness against pneumococcal disease. : Seven records disclosing results from six studies on PHiD-CV/PCV13 interchangeability were identified. Four clinical trials showed that mixed schedules with a PHiD-CV-to-PCV13 switch at boosting or a PCV13-to-PHiD-CV switch during priming or at boosting were immunogenic with no apparent safety concerns. Two observational studies in the context of a programmatic PHiD-CV-to-PCV13 switch showed similarly high effectiveness against overall invasive pneumococcal disease with a mixed PHiD-CV/PCV13 schedule and a PCV13-only schedule. No effectiveness data for a PCV13-to-PHiD-CV switch and no immunogenicity/safety/effectiveness data for a PHiD-CV-to-PCV13 switch during priming were found. : For epidemiological or programmatic reasons, several local/national authorities have switched PCVs in their immunization programs. Consequently, children have received mixed schedules. Although herd immunity may obscure the individual effect, the limited data are reassuring. Additional evidence from these settings - especially effectiveness or impact data - may provide the necessary information for authorities to make informed decisions on interchanging PCVs.
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http://dx.doi.org/10.1080/14760584.2019.1688148DOI Listing
November 2020

[Risk factors and lethality associated with neonatal candidemia in a neonatal unit].

Rev Chil Pediatr 2019 Apr;90(2):186-193

Hospital Dr. Manuel Nieto, Darién, Panamá.

Objective: To identify the main risk factors associated with neonatal candidemia.

Patients And Method: A retrospective paired case-control study was conducted from January 2014 to December 2016. The cases were patients with isolation in blood culture and/or cerebrospinal fluid of Candi da spp. after their first 48 hours in the hospital and the controls cases were neonates chosen from the statistical census of neonatology paired according to their admission date (30-day range), birth weight, gestational age, and discharge condition (alive or deceased). For each case, we select two controls. The risk factors evaluated were intrahospital stay over seven days, use of broad-spectrum antibiotics, mechanical ventilation, parenteral nutrition longer than five days, invasive procedures such as central venous access and abdominal and thoracic surgeries, necrotizing enterocolitis and growth of bacterial microorganisms in blood culture before candidemia.

Results: During the study period, 141 patients developed candidemia. 49% of the cases corresponded to Candida parapsilosis with the highest associated lethality rate. The multivariate analysis identified as risk factors hospital stay longer than seven days (OR = 17.0, 95% CI = 2.36-122.4), use of umbilical lines (OR = 9.04, 95% CI = 1.55-52.5), abdominal and/or thoracic surgery (OR = 12.4, 95% CI = 1.76-87.3), and treatment with Meropenem (OR = 4.62, 95% CI = 1.34-15.9).

Conclusion: Prolonged intrahospital stay longer than seven days and thoracic and/or abdominal surgery were the most significant risk factors in this study for the development of neonatal candidemia.
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http://dx.doi.org/10.32641/rchped.v90i2.717DOI Listing
April 2019

Hepatitis B seroprevalence in 10-25-year-olds in Mexico - the 2012 national health and nutrition survey (ENSANUT) results.

Hum Vaccin Immunother 2019 5;15(2):433-439. Epub 2018 Nov 5.

a Centro de Investigación Sobre Enfermedades Infecciosas, Instituto Nacional de Salud Pública , Morelos , México.

Objectives: To estimate hepatitis B virus (HBV) seroprevalence from natural infection or vaccination in 10-25-year-olds in Mexico, using the 2012 National Health and Nutrition Survey (ENSANUT).

Methods: Randomly selected serum samples (1,581) from adolescents and young adults, representative of 38,924,584 Mexicans, were analyzed to detect hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc). Weighted HBV seroprevalence in the Mexican population and association with sociodemographic variables were calculated.

Results: Overall weighted seroprevalence from natural infection (positive for anti-HBs and anti-HBc) was 0.23% (95% confidence interval [95% CI] 0.10-0.52). No HBsAg was detected, indicating no acute or chronic infection. Vaccine-derived immunity (positive ≥ 10.0 mIU/ml for anti-HBs and negative to anti-HBc) was 44.7% (95% CI: 40.2-49.4) overall; lower in persons aged 20-25 years (40.83%) than in persons aged 10-19 years (47.7%). Among the population analyzed, 54.2% (95% CI: 49.6-58.8) were seronegative to HBV (negative for all three markers) and no sociodemographic risk factors were identified.

Conclusions: HBV seroprevalence from natural infection was low. Vaccination-induced immunity was higher among Mexican adolescents than young adults, possibly due to vaccination policies since 1999.
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http://dx.doi.org/10.1080/21645515.2018.1533617DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6422518PMC
February 2020

Vaccine coverage and compliance in Mexico with the two-dose and three-dose rotavirus vaccines.

Hum Vaccin Immunother 2019 11;15(6):1251-1259. Epub 2018 Dec 11.

b GSK, City of Knowledge , Clayton, Ancon , Panama.

Worldwide, rotavirus infection has been a leading cause of severe diarrhea morbidity and mortality. Two rotavirus vaccines have been used in the National Immunization Program (NIP) in Mexico; two-dose from 2006 to 2011 and three-dose since 2011. This study assessed coverage (receiving at least one dose or full dose series) in eligible infants, compliance (% completing dose series and % completing series on schedule) in eligible infants vaccinated with (2010) versus (2012), using Mexican Social Security Institute data nationwide and by regions. In 2010, 80.7% received at least one dose of , 75.6% received both doses and 57.0% received both doses on schedule. In 2012, 85.7% received at least one dose of , 61.0% received all three doses and 43.2% received all three doses on schedule. More eligible infants received all doses with versus (p < 0.001). Among infants vaccinated with versus , 93.7% versus 71.1% completed full series (p < 0.001), and 75.5% versus 70.9% completed full series on schedule (p = 0.105), respectively. The full series coverage and compliance decreased in all regions with compared with . In conclusion, rotavirus vaccination has successfully reduced morbidity and mortality in children under 5 years in Mexico. This study found significant differences in full series coverage and compliance among infants and a higher proportion of completed scheduled at an earlier age in Mexico when comparing a two-dose vaccine in 2010 with a three-dose vaccine in 2012. Such differences might need to be taken into consideration to maximize NIP benefits, including early protection of the rotavirus vaccination program.
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http://dx.doi.org/10.1080/21645515.2018.1540827DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6783135PMC
March 2020

Hepatitis A seroprevalence in adolescents and young adults in Mexico: A 2012 National Health and Nutrition Survey analysis.

Vaccine 2018 12 15;36(52):8094-8099. Epub 2018 Oct 15.

Centro de Investigación Sobre Enfermedades Infecciosas, Instituto Nacional de Salud Pública, Av. Universidad # 655, Col. Sta. María Ahuacatitlán, C.P. 62100 Cuernavaca, Morelos, Mexico. Electronic address:

To describe hepatitis A virus (HAV) seroprevalence and associated factors in adolescents (10-19 years) and young adults (20-25 years) in different Mexican regions, using 2012 National Health and Nutrition Survey data. A random selection of 1581 serum samples was analyzed. Weighted HAV seroprevalence with 95% confidence intervals (95%CI) and its association with sociodemographic factors were estimated. Mean weighted HAV seroprevalence was 69.3% (95%CI: 64.8-73.4) overall, with 58.8% (95%CI: 53.4-64.1) in adolescents and 83.0% (95%CI: 75.3-88.7) in young adults. By age of 10, 46.7% (95%CI: 33.9-60.0) were seropositive and by age of 15, 52.8% (95%CI: 36.5-68.5), corresponding to intermediate endemicity nationally. Factors associated with HAV seropositivity (adjusted odds ratio, aOR) included: lower socioeconomic status (SES) (aOR = 4.09 for low and aOR = 2.31 for medium versus high SES), older age (aOR = 0.29 for adolescents versus young adults), living in the South (aOR = 2.12 versus Central Mexico) or in rural areas (aOR = 2.25 versus urban areas). Regional differences and increased seroprevalence of HAV in marginalized populations present an important public health issue, as a relatively large proportion of young adults are susceptible to infection. The burden of symptomatic disease must be addressed further to support specific programs of continued sanitation and education improvement, and the possibility of vaccination in more susceptible regions.
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http://dx.doi.org/10.1016/j.vaccine.2018.10.037DOI Listing
December 2018

Vaccination herd effect experience in Latin America: a systematic literature review.

Hum Vaccin Immunother 2019 19;15(1):49-71. Epub 2018 Sep 19.

b GSK , Panama City , Panama.

Background: National pediatric vaccination programs have been introduced in Latin America (LatAm) to reduce the burden of diseases due to pathogens such as rotavirus, Haemophilus influenzae type b (Hib) and pneumococcus. Vaccination health benefits may extend to unvaccinated populations by reducing pathogen transmission. Understanding herd effect is important for implementation and assessment of vaccination programs. The objective was to conduct a systematic review of published epidemiological evidence of herd effect with Hib, rotavirus and pneumococcal conjugate vaccines (PCV) in LatAm.

Methods: Searches were conducted in PubMed, Virtual Health Library (VHL), SciELO and SCOPUS databases, for studies reporting data on herd effect from Hib, rotavirus and PCV vaccination in LatAm, without age restriction. Searches were limited to articles published in English, Spanish or Portuguese (1990-2016). After screening and full-text review, articles meeting the selection criteria were included to be critically appraised following criteria for observational and interventional studies. The presence of a herd effect was defined as a significant decrease in incidence of disease, hospitalization, or mortality.

Results: 3,465 unique articles were identified, and 23 were included (Hib vaccine n = 5, PCV n = 8, rotavirus vaccine n = 10). Most studies included children and/or adolescents (age range varied between studies). Studies in adults, including older adults (aged > 65 years), were limited. Few studies reported statistically significant reductions in disease incidence in age groups not targeted for vaccination. Hib-confirmed meningitis hospitalization decreased in children but herd effect could not be quantified. Some evidence of herd effect was identified for PCV and rotavirus vaccine in unvaccinated children. Evidence for herd effects due to PCV in adults was limited.

Conclusion: After introduction of Hib, PCV and rotavirus vaccination in LatAm, reductions in morbidity/mortality have been reported in children not targeted for vaccination. However, due to methodological limitations (e.g. short post-vaccination periods and age range studied), there is currently insufficient evidence to quantify the herd effect in adult populations. More research and higher quality surveillance is needed to characterize herd effect of these vaccines in LatAm.
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http://dx.doi.org/10.1080/21645515.2018.1514225DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6363147PMC
February 2020

Economic burden of varicella complications in two referral centers in Mexico.

Hum Vaccin Immunother 2018 23;14(12):2950-2954. Epub 2018 Oct 23.

b Departamento de Infectología , Hospital Infantil de México Federico Gómez , México City , México.

Varicella-zoster virus causes varicella (chicken-pox), mainly in young children. Most cases are mild but serious complications can occur, resulting in significant morbidity and mortality. The objective of this study was to estimate the cost burden of varicella hospitalizations in two pediatric reference hospitals in Mexico. This retrospective observational study collected data on patients aged <18 years admitted to two third-level referral hospitals in Mexico. Cases were identified from hospital records using International Classification of Diseases Ninth Revision (ICD-9) codes 052 Chickenpox, or Tenth Revision (ICD-10) codes B01 Varicella (chickenpox). Data on demographic and clinical characteristics and resource use were collected from hospital records. Costs for hospital stay and interventions were obtained from the Mexican Institute for Social Security for 2015 and updated to 2017 costs. A total of 172 hospitalized varicella clinically-confirmed cases and 121 varicella- contacts (with epidemiological linkage to a clinically-confirmed case) were included. Thirty eight of the 172 cases (22.0%) experienced complications. There were no deaths. The median duration of hospitalization was 12 days for cases and 23 days for contacts. The median hospitalization cost was MXN 82,572 (USD 4,434) per case, and MXN 89,453 (USD 4,804) per contact. Although considered a mild disease, varicella was associated with a substantial cost burden in two Mexican third-level referral hospitals.
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http://dx.doi.org/10.1080/21645515.2018.1504541DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6343601PMC
October 2018

Streptococcus pneumoniae serotype 19A in Latin America and the Caribbean 2010-2015: A systematic review and a time series analysis.

Vaccine 2018 08 6;36(32 Pt B):4861-4874. Epub 2018 Jul 6.

Instituto Nacional de Salud Bogotá, Colombia. Electronic address:

Background: This systematic review aims to describe the prevalence, trends, and antibiotic resistance of Streptococcus pneumoniae serotype 19A (Spn19A) that causes invasive and non-invasive diseases in children <5 years in Latin-American and Caribbean countries.

Methods: We searched for published (between January 2010 and February 2016) observational and clinical studies within the region including effectiveness and impact on Spn19A after pneumococcal conjugate vaccine (PCV) introduction. We calculated prevalence estimates by country and standardized the frequency of isolates to conduct an interrupted time series analysis for selected countries and to assess the potential changes in disease trends, overall and for Spn19A.

Results: We identified and reviewed full-text of 89 publications and included 59 in the analysis. Data from the laboratory surveillance network, SIREVA, were included in 43 (74%) of the invasive pneumococcal disease reports. There are differences in the sensitivity, representativeness, and heterogeneity of laboratory surveillance. There has been and overall reduction in the trend and number of invasive S. pneumoniae isolates in children <5 years after PCVs introduction. To date, the prevalence of Spn19A has increased, however, there has been no observed change in the trend.

Conclusions: This updated systematic review provides evidence of a reduction in the total number of invasive pneumococcal disease isolates after the introduction of PCVs in the region but cannot yet conclude a change in the trend of Spn19A disease.
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http://dx.doi.org/10.1016/j.vaccine.2018.06.068DOI Listing
August 2018

The burden of influenza A and B in Mexico from the year 2010 to 2013: An observational, retrospective, database study, on records from the Directorate General of Epidemiology database.

Hum Vaccin Immunother 2018 10;14(8):1890-1898. Epub 2018 May 10.

h Faculty of Medicine, National Autonomous University of Mexico, Division of Graduate Studies , Avenida Universidad 3000, Copilco El Bajo, Coyoacan, CDMX, Ciudad de México , México.

Despite vaccination programs, influenza still represents a significant disease burden in Mexico. We conducted an observational, retrospective analysis to better understand the epidemiological situation of the influenza virus in Mexico. Analysis of the seasonal patterns of influenza A and B were based on the Directorate General of Epidemiology dataset of influenza-like illness(ILI), and severe acute respiratory infection(SARI) that were recorded between January 2010 and December 2013. Our objectives were 1) to describe influenza A and B activity, by age group, and subtype and, 2) to analyze the number of laboratory-confirmed cases presenting with ILI by influenza type, the regional distribution of influenza, and its clinical features. Three periods of influenza activity were captured: August 2010-January 2011, December 2011-March 2012, and October 2012-March 2013. Cases were reported throughout Mexico, with 50.3% (n = 10,320) of cases found in 18-49 year olds. Over the entire capture period, a total of 76,085 ILI/SARI episodes had swab samples analyzed for influenza, 27% were positive. During the same period, influenza A cases were higher in the 18-49 years old, and influenza B cases in both 5-17 and 18-49 age groups. Peak activity occurred in January 2012 (n = 4,159) and December 2012 (n = 348) for influenza A and B respectively. This analysis confirms that influenza is an important respiratory pathogen for children and adults in Mexico despite vaccination recommendations. School-age children and adolescents were more prone to influenza B infection; while younger adults were susceptible to both influenza A and B viruses. Over the seasons, influenza A and B co-circulated.
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http://dx.doi.org/10.1080/21645515.2018.1456281DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6149840PMC
April 2019

Pneumococcal meningitis trends after pneumococcal conjugate vaccine introduction in Colombia: An interrupted time-series analysis.

Hum Vaccin Immunother 2018 05 12;14(5):1230-1233. Epub 2018 Feb 12.

b GSK , Panamá City , Panamá.

Colombia introduced mass pneumococcal conjugate vaccination at the end of 2011. Using 2005-2015 surveillance data, we conducted a retrospective interrupted time-series analysis. A significant trend towards reduced monthly was observed in the post-vaccination period (2012-2015) compared with the expected rate, reaching in 2015 a reduction of 90.5% of pneumococcal meningitis. This trend was not observed for control diseases.
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http://dx.doi.org/10.1080/21645515.2018.1425115DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5989909PMC
May 2018

Incidence and economic burden of acute otitis media in children aged up to 5years in three Middle Eastern countries and Pakistan: A multinational, retrospective, observational study.

J Epidemiol Glob Health 2017 06 8;7(2):123-130. Epub 2017 Feb 8.

GSK, Siena, Italy. Electronic address:

Epidemiological data on acute otitis media (AOM), an infectious disease frequently affecting children, are lacking in some countries. This study was undertaken to assess the incidence of AOM in children ≤5years in Saudi Arabia, Oman, Pakistan, and Turkey, as well as the economic burden from a parent/caregiver perspective. Medical records of 4043 children (Saudi Arabia=1023, Oman=998, Pakistan=1022, Turkey=1000) were retrospectively reviewed and the incidence of AOM episodes calculated from suspected and confirmed cases. Using a standardized Health Economics Questionnaire, parents recorded resource use and expenses incurred per AOM episode [in local currency and converted to US dollars (USD)]. The overall incidence of AOM episodes per 1000 person-years was: Saudi Arabia, 207 [95% confidence interval (CI): 178-238]; Oman, 105 (95% CI: 85-127); Pakistan, 138 (95% CI: 116-163); and Turkey, 99 (95% CI: 79-123). The mean total out-of-pocket healthcare expense incurred by parents/caregivers per episode was: Saudi Arabia USD67.1 [standard deviation (SD)=93.0], Oman USD16.1 (SD=16.4), Pakistan USD22.1 (SD=20.5), and Turkey USD33.6 (SD=44.9). The incidence of AOM episodes varied across all four countries, probably due to different diagnostic and management practices. Nevertheless, our results confirm that AOM causes a substantial burden to public health, reinforcing the need for cost-effective prevention strategies.
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http://dx.doi.org/10.1016/j.jegh.2016.12.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7320432PMC
June 2017

Efficacy, safety and effectiveness of licensed rotavirus vaccines: a systematic review and meta-analysis for Latin America and the Caribbean.

BMC Pediatr 2017 01 13;17(1):14. Epub 2017 Jan 13.

GSK Vaccines, Panamá City, Panamá.

Background: RotaTeq™ (RV5; Merck & Co. Inc., USA) and Rotarix™ (RV1, GlaxoSmithKline, Belgium) vaccines, developed to prevent rotavirus diarrhea in children under five years old, were both introduced into national immunization programs in 2006. As many countries in Latin America and the Caribbean have included either RV5 or RV1 in their routine childhood vaccination programs, we conducted a systematic review and meta-analysis to analyze efficacy, safety and effectiveness data from the region.

Methods: We conducted a systematic search in PubMed, EMBASE, Scielo, Lilacs and the Cochrane Central Register, for controlled efficacy, safety and effectiveness studies published between January 2000 until December 2011, on RV5 and RV1 across Latin America (where both vaccines are available since 2006). The primary outcome measures were: rotavirus-related gastroenteritis of any severity; rotavirus emergency department visits and hospitalization; and severe adverse events.

Results: The results of the meta-analysis for efficacy show that RV1 reduced the risk of any-severity rotavirus-related gastroenteritis by 65% (relative risk (RR) 0.35, 95% confidence interval (CI) 0.25; 0.50), and of severe gastroenteritis by 82% (RR 0.18, 95%CI 0.12; 0.26) versus placebo. In trials, both vaccines significantly reduced the risk of hospitalization and emergency visits by 85% (RR 0.15, 95%CI 0.09; 0.25) for RV1 and by 90% (RR 0.099, 95%CI 0.012; 0.77) for RV5. Vaccination with RV5 or RV1 did not increase the risk of death, intussusception, or other severe adverse events which were previously associated with the first licensed rotavirus vaccine. Real-world effectiveness studies showed that both vaccines reduced rotavirus hospitalization in the region by around 45-50% for RV5 (for 1 to 3 doses, respectively), and, by around 50-80% for RV1 (for 1 to 2 doses, respectively). For RV1, effectiveness against hospitalization was highest (around 80-96%) for children vaccinated before 12 months of age, compared with 5-60% effectiveness in older children. Both vaccines were most effective in preventing more severe gastroenteritis (70% for RV5 and 80-90% for RV1) and severe gastroenteritis (50% for RV5 and 70-80% for RV1).

Conclusion: This systematic literature review confirms rotavirus vaccination has been proven effective and well tolerated in protecting children in Latin America and the Caribbean.
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http://dx.doi.org/10.1186/s12887-016-0771-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5237165PMC
January 2017

Epidemiology of community-acquired pneumonia and implications for vaccination of children living in developing and newly industrialized countries: A systematic literature review.

Hum Vaccin Immunother 2016 09 7;12(9):2422-40. Epub 2016 Jun 7.

d School for Public Health and Primary Care (CAPHRI), Maastricht University , Maastricht , The Netherlands.

This systematic review evaluated the epidemiology of community-acquired pneumonia in children <6 y of age within 90 developing and newly industrialized countries. Literature searches (1990-2011), based on MEDLINE, EMBASE, Cochrane, CAB Global Health, WHO, UNICEF, country-specific websites, conferences, health-technology-assessment agencies, and the reference lists of included studies, yielded 8,734 records; 62 of 340 studies were included in this review. The highest incidence rate among included studies was 0.51 episodes/child-year, for children <5 y of age in Bangladesh. The highest prevalence was in Chinese children <6 months of age (37.88%). The main bacterial pathogens were Streptococcus pneumoniae, Haemophilus influenzae and Mycoplasma pneumoniae and the main viral pathogens were respiratory syncytial virus, adenovirus and rhinovirus. Community-acquired pneumonia remains associated with high rates of morbidity and mortality. Improved and efficient surveillance and documentation of the epidemiology and burden of community-acquired pneumonia across various geographical regions is warranted.
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http://dx.doi.org/10.1080/21645515.2016.1174356DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5027706PMC
September 2016

Epidemiology of otitis media in children from developing countries: A systematic review.

Int J Pediatr Otorhinolaryngol 2016 Jun 11;85:65-74. Epub 2016 Apr 11.

School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands; Kleijnen Systematic Reviews Ltd, York, United Kingdom. Electronic address:

Objective: This systematic review examined the epidemiology of otitis media (OM) in children <6 years within 90 developing and newly industrialised countries.

Methods: Literature searches (1992-2011), based on MEDLINE, EMBASE, WHO, Index Medicus, country-specific websites, conferences, and the reference lists of included studies, yielded 11,413 records; 59 of 344 studies analysed were included in this review.

Results: The majority of the identified studies provided only a single timepoint for OM. In children <6 years of age, OM prevalence was found to be 9.2% in Nigeria, 10% in Egypt, 6.7% in China, 9.2% in India, 9.1% in Iran and 5.1-7.8% in Russia. Few studies examined the etiology of OM and the antibacterial resistance. The most common bacterial pathogens were S. pneumoniae, H. influenzae and S. aureus. A high resistance to penicillin was reported in Nigeria and Turkey.

Conclusions: Despite the variability between the identified studies, this review indicates that OM and its various sub-types remain a significant burden in different settings. However, the heterogeneity of studies and a general lack of reliable data made generalisation very difficult.
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http://dx.doi.org/10.1016/j.ijporl.2016.03.032DOI Listing
June 2016

Impact of Hepatitis A vaccination with a two-dose schedule in Panama: Results of epidemiological surveillance and time trend analysis.

Vaccine 2015 Jun 14;33(28):3200-7. Epub 2015 May 14.

GSK Vaccines, LATAM, Bogotá, Colombia.

Purpose: In April 2007, Panama introduced Hepatitis A universal vaccination using a two-dose schedule (Havrix(®)junior; GSK Vaccines, Belgium). We assessed the impact of this hepatitis A vaccine three years after it was recommended for universal mass vaccination in Panama.

Materials And Methods: Hepatitis A vaccination impact was assessed using two different approaches. The first approach used retrospective data (incidence and number of cases for all age groups), collected from the passive surveillance of the Epidemiologic Surveillance System of the Ministry of Health of hepatitis A and unspecified hepatitis before (2000-2006) and after (2008-2010) introduction of hepatitis A vaccine. The second approach was a prospective hospital-based active surveillance for hepatitis cases conducted in subjects (0-14 years) during 2009-2011 at three sentinel hospitals in Panama.

Results: Overall, the annual incidence of hepatitis A and unspecified hepatitis in 2008, 2009 and 2010 were 13.1, 7.9 and 3.7 per 100,000 subjects, lower than the baseline incidence of 51.1 per 100,000 subjects. In comparison to the mean baseline period (2000-2006), there was an 82% mean reduction in the overall hepatitis-related outcomes (hepatitis A and unspecified hepatitis) after vaccine introduction (2008-2010) in all age groups. In the hospital-based surveillance (2009-2011), of the 42 probable viral hepatitis A cases, nine cases were confirmed as acute hepatitis A (8 in 2009, 1 in 2010). Of these confirmed cases, two belonged to the targeted vaccine group (1-4 years) but were not vaccinated.

Conclusions: Our study suggests that the introduction of two-dose hepatitis A vaccines in Panama has contributed to the reduction in the incidence of overall hepatitis-related outcomes for all age groups, suggesting herd protection. Additional monitoring is required to document a sustained long-term effect.
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http://dx.doi.org/10.1016/j.vaccine.2015.04.100DOI Listing
June 2015

Gastroenteritis attributable to rotavirus in hospitalized Saudi Arabian children in the period 2007-2008.

Clin Epidemiol 2015 11;7:129-37. Epub 2015 Feb 11.

GlaxoSmithKline Vaccines, Wavre, Belgium.

Purpose: Rotavirus (RV) is a leading cause of severe gastroenteritis (GE) in children across the world. As there is a lack of epidemiological data for RV gastroenteritis (RVGE) in Saudi Arabia, this hospital-based study was designed to estimate the disease burden of RVGE and assess the prevalent RV types in Saudi children younger than 5 years of age.

Patients And Methods: Children hospitalized for acute GE were enrolled at four pediatric referral hospitals in Saudi Arabia. The study was conducted from February 2007 to March 2008 and used the World Health Organization's generic protocol for RVGE surveillance. The Vesikari severity scale was used to assess the severity of RVGE. Stool samples were tested for RV using an enzyme-linked immunosorbent assay. Samples were further typed by reverse transcriptase-polymerase chain reaction and hybridization assay for determining the G and P types.

Results: A total of 1,007 children were enrolled; the final analysis included 970 children, of whom 395 were RV positive, 568 were RV negative, and seven had unknown RV status. The proportion of RVGE among GE hospitalizations was 40.7% (95% confidence interval: 37.6-43.9). The highest percentage of RVGE hospitalizations (83.1%) was seen in children younger than 2 years of age. The highest proportion of RV among GE hospitalizations was in June 2007 with 57.1%. The most common RV types detected were G1P[8] (49.3%), G1G9P[8] (13.2%), and G9P[8] (9.6%). Before hospitalization, severe GE episodes occurred in 88.1% RV-positive and 79.6% RV-negative children. Overall, 94% children had recovered by the time they were discharged. Two children (one RV positive and one RV negative) died due to GE complications.

Conclusion: RVGE is responsible for a high proportion of hospitalizations in Saudi children younger than 5 years of age. Routine RV vaccination has therefore been introduced into the national immunization program and may help reduce the morbidity, mortality, and disease burden associated with RVGE in Saudi Arabia.
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http://dx.doi.org/10.2147/CLEP.S69502DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4334312PMC
February 2015

Etiology and antimicrobial susceptibility of middle ear fluid pathogens in Costa Rican children with otitis media before and after the introduction of the 7-valent pneumococcal conjugate vaccine in the National Immunization Program: acute otitis media microbiology in Costa Rican children.

Medicine (Baltimore) 2015 Jan;94(2):e320

From the Instituto de Atención Pediátrica, San José, Costa Rica (AAb, AAr, CS); Universidad Autónoma de Ciencias Médicas, San José, Costa Rica (AAr); Pediatric Infectious Disease Unit, Soroka University Medical Center, Beer-Sheva, Israel (RDa, NP); GlaxoSmithKline Vaccines, Panama City, Panama (MMC, EO-B, RDA) GlaxoSmithKline Vaccines, Wavre, Belgium (RC, J-YP, RD, MVD).

Acute otitis media (AOM) microbiology was evaluated in children after 7-valent pneumococcal conjugate vaccine (PCV7) introduction in Costa Rica (private sector, 2004; National Immunization Program, 2009). This was a combined prospective and retrospective study conducted in a routine clinical setting in San José, Costa Rica. In the prospective part of the study, which was conducted post-PCV7 introduction (2010-2012), standard bacteriological procedures were used to evaluate the etiology and serotype distribution of middle ear fluid samples collected by tympanocentesis or otorrhea from children aged 3-59 months diagnosed with AOM. E-tests were used to evaluate antimicrobial susceptibility in culture-positive samples. Retrospective data recorded between 1999 and 2004 were used for comparison of bacterial etiology and serotype distribution before and after PCV7 introduction. Statistical significance was evaluated in bivariate analyses at the P-value < 0.05 level (without multiplicity correction). Post-PCV7 introduction, Haemophilus influenzae was detected in 118/456 and Streptococcus pneumoniae in 87/456 AOM episodes. Most H. influenzae isolates (113/118) were non-typeable. H. influenzae was more (27.4% vs 20.8%) and S. pneumoniae less (17.1% vs 25.5%) frequently observed in vaccinated (≥ 2 PCV7 doses or ≥ 1 PCV7 dose at >1 year of age) versus unvaccinated children. S. pneumoniae non-susceptibility rates were 1.1%, 34.5%, 31.7%, and 50.6% for penicillin, erythromycin, azithromycin, and trimethoprim/sulfamethoxazole (TMP-SMX), respectively. H. influenzae non-susceptibility rate was 66.9% for TMP-SMX. Between pre- and post-PCV7 introduction, H. influenzae became more (20.5% vs 25.9%; P-value < 0.001) and S. pneumoniae less (27.7% vs 19.1%; P-value = 0.002) prevalent, and PCV7 serotype proportions decreased among pneumococcal isolates (65.8% vs 43.7%; P-value = 0.0005). Frequently identified pneumococcal serotypes were 19F (34.2%), 3 (9.7%), 6B (9.7%), and 14 (9.7%) pre-PCV7 introduction, and 19F (27.6%), 14 (8.0%), and 35B (8.0%) post-PCV7 introduction. Following PCV7 introduction, a change in the distribution of AOM episodes caused by H. influenzae and pneumococcal serotypes included in PCV7 was observed in Costa Rican children. Pneumococcal vaccines impact should be further evaluated following broader vaccination coverage.
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http://dx.doi.org/10.1097/MD.0000000000000320DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4602541PMC
January 2015

Human papillomavirus prevalence and type distribution among women attending routine gynecological examinations in Saudi Arabia.

BMC Infect Dis 2014 Dec 14;14:643. Epub 2014 Dec 14.

GlaxoSmithKline Vaccines, Wavre, Belgium.

Background: Cervical cancer (CC) is caused by persistent infection with high-risk (HR) human papillomavirus (HPV) types. In Saudi Arabia which has a population of 6.5 million women over the age of 15 years, approximately 152 new cases of CC are diagnosed and 55 women die from the disease annually. Nevertheless current epidemiological data for HPV in this population are limited. This study evaluated the prevalence and type distribution of HPV and documented the awareness of HPV infection and health-related behavior among Saudi and non-Saudi women attending routine examination.

Methods: This was an observational, epidemiological cross-sectional study conducted between April 2010 and December 2011 at three hospitals in Saudi Arabia. Cervical samples from women aged ≥15 years, who were attending routine gynecological examinations were collected and tested for HPV-DNA by polymerase chain reaction and typed using the SPF10 DEIA/LiPA25 system. Two questionnaires on health-related behavior and awareness of HPV infection were completed.

Results: A total of 417 women, mean age (standard deviation) 41.9 (±10.4) years, were included in the final analysis, of whom 77% (321/417) were Saudi nationals. HPV-DNA was detected in 9.8% women (41/417, 95% confidence interval [CI]: 7.1-13.1). The prevalence of any HR-HPV by age was: 25-34 years: 3.0%; 35-44 years: 4.5%; 45-54 years: 3.2%; >55 years: 10.9%. The most prevalent HR-HPV-types were: HPV-68/73 (5 cases); HPV-18 (4 cases); HPV-16 (3 cases). The most prevalent low risk (LR) types were HPV-6 (4 cases); HPV-42, HPV-53 and HPV-54 (2 cases each). The prevalence of HPV was higher among non-Saudi nationals vs. Saudi nationals (16.7% vs. 7.8%, P = 0.0234). No statistically significant risk factors were identified: 32.2% (101/314) women were aware of HPV and 89.9% (285/317) showed an interest in HPV vaccination.

Conclusion: The overall prevalence of HPV was 9.8% in Saudi Arabia, but was higher in women over 55 years, as well as in non-Saudi nationals. These data provide a reference for public health authorities and may also help in determining future policies for the prevention of CC.

Clinical Trial Registration: NCT01213459.
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http://dx.doi.org/10.1186/s12879-014-0643-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4272558PMC
December 2014

An epidemiological study assessing the prevalence of human papillomavirus types in women in the Kingdom of Bahrain.

BMC Cancer 2014 Dec 3;14:905. Epub 2014 Dec 3.

Arabian Gulf University/Medical College, Manama, Bahrain.

Background: Persistent infection with high-risk (HR) human papillomavirus (HPV) causes cervical cancer, the fourth most frequent cancer in the Kingdom of Bahrain, with an annual incidence of four per 100,000 women. The aim of this study was to assess the prevalence and type distribution of HPV in Bahraini and non-Bahraini women attending routine screening. HPV prevalence was assessed by risk factors and age distribution. Health-related behaviors and HPV awareness were also studied.

Methods: This observational study was conducted between October 2010 and November 2011 in the Kingdom of Bahrain (NCT01205412). Women aged either ≥20 years attending out-patient health services for routine cervical screening or ≥16 years attending post-natal check-ups were enrolled. Cervical samples were collected and tested for HPV-DNA by polymerase chain reaction and typed using the SPF10 DEIA/LiPA25 system. All women completed two questionnaires on health-related behavior (education level, age at first marriage, number of marital partners, parity and smoking status) and HPV infection awareness.

Results: HPV DNA was detected in 56 of the 571 women included in the final analysis (9.8%); 28 (4.9%), 15 (2.6%) and 13 (2.3%) women were infected with single, multiple and unidentifiable HPV types, respectively. The most prevalent HPV types among the HPV positive women were HR-HPV-52 in eight (1.4%), HR-HPV-16, -31 and -51 in six women each (1.1%); low-risk (LR)-HPV-6 in four (0.7%); and LR-HPV-70, -74 in three women each (0.5%). Co-infection with other HR-HPV types was observed in 50% HPV-16-positive women (with HPV-31, -45 and -56) and in both HPV-18-positive women (with HPV-52). None of the health-related risk factors studied were associated with any HR-HPV infection. More than half of women (68.7%) had never heard about HPV, but most women (91.3%) in our study were interested in HPV-vaccination.

Conclusion: HPV prevalence in Bahraini women was 9.8%. The most frequently observed HPV types were HR-HPV-52, -16, -31 and -51 and LR-HPV-6, -70 and -74. These are useful baseline data for health authorities to determine the potential impact of preventive measures including the use of prophylactic vaccines to reduce the burden of cervical cancer.
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http://dx.doi.org/10.1186/1471-2407-14-905DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4265506PMC
December 2014