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JAMA Pediatrics Jul 2021Rotavirus vaccines have been introduced worldwide, and the clinical association of different rotavirus vaccines with reduction in rotavirus gastroenteritis (RVGE) after... (Meta-Analysis)
Meta-Analysis
Association of Rotavirus Vaccines With Reduction in Rotavirus Gastroenteritis in Children Younger Than 5 Years: A Systematic Review and Meta-analysis of Randomized Clinical Trials and Observational Studies.
IMPORTANCE
Rotavirus vaccines have been introduced worldwide, and the clinical association of different rotavirus vaccines with reduction in rotavirus gastroenteritis (RVGE) after introduction are noteworthy.
OBJECTIVE
To evaluate the comparative benefit, risk, and immunogenicity of different rotavirus vaccines by synthesizing randomized clinical trials (RCTs) and observational studies.
DATA SOURCES
Relevant studies published in 4 databases: Embase, PubMed, the Cochrane Library, and Web of Science were searched until July 1, 2020, using search terms including "rotavirus" and "vaccin*."
STUDY SELECTION
Randomized clinical trials and cohort and case-control studies involving more than 100 children younger than 5 years that reported the effectiveness, safety, or immunogenicity of rotavirus vaccines were included.
DATA EXTRACTION AND SYNTHESIS
A random-effects model was used to calculate relative risks (RRs), odds ratios (ORs), risk differences, and 95% CIs. Adjusted indirect treatment comparison was performed to assess the differences in the protection of Rotarix and RotaTeq.
MAIN OUTCOMES AND MEASURES
The primary outcomes were RVGE, severe RVGE, and RVGE hospitalization. Safety-associated outcomes involved serious adverse events, intussusception, and mortality.
RESULTS
A meta-analysis of 20 RCTs and 38 case-control studies revealed that Rotarix (RV1) significantly reduced RVGE (RR, 0.316 [95% CI, 0.224-0.345]) and RVGE hospitalization risk (OR, 0.347 [95% CI, 0.279-0.432]) among children fully vaccinated; RotaTeq (RV5) had similar outcomes (RVGE: RR, 0.350 [95% CI, 0.275-0.445]; RVGE hospitalization risk: OR, 0.272 [95% CI, 0.197-0.376]). Rotavirus vaccines also demonstrated higher protection against severe RVGE. Additionally, no significant differences in the protection of RV1 and RV5 against rotavirus disease were noted in adjusted indirect comparisons. Moderate associations were found between reduced RVGE risk and Rotavac (RR, 0.664 [95% CI, 0.548-0.804]), Rotasiil (RR, 0.705 [95% CI, 0.605-0.821]), and Lanzhou lamb rotavirus vaccine (RR, 0.407 [95% CI, 0.332-0.499]). All rotavirus vaccines demonstrated no risk of serious adverse events. A positive correlation was also found between immunogenicity and vaccine protection (eg, association of RVGE with RV1: coefficient, -1.599; adjusted R2, 99.7%).
CONCLUSIONS AND RELEVANCE
The high protection and low risk of serious adverse events for rotavirus vaccines in children who were fully vaccinated emphasized the importance of worldwide introduction of rotavirus vaccination. Similar protection provided by Rotarix and RotaTeq relieves the pressure of vaccines selection for health care authorities.
Topics: Child, Preschool; Gastroenteritis; Humans; Infant; Infant, Newborn; Randomized Controlled Trials as Topic; Rotavirus Infections; Rotavirus Vaccines
PubMed: 33970192
DOI: 10.1001/jamapediatrics.2021.0347 -
The Pediatric Infectious Disease Journal Dec 2021Rotavirus causes 215,000 deaths from severe childhood diarrhea annually. Concerns exist that a monovalent vaccine (RV1) and a pentavalent vaccine (RV5) may be less... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Rotavirus causes 215,000 deaths from severe childhood diarrhea annually. Concerns exist that a monovalent vaccine (RV1) and a pentavalent vaccine (RV5) may be less effective against rotavirus strains not contained in the vaccines. We estimated the vaccine effectiveness (VE) of RV1 and RV5 against severe rotavirus gastroenteritis caused by vaccine (homotypic) and nonvaccine (partially and fully heterotypic) strains.
METHODS
After conducting a systematic review, we meta-analyzed 31 case-control studies (N = 27,293) conducted between 2006 and 2020 using a random-effects regression model.
RESULTS
In high-income countries, RV1 VE was 10% lower against partially heterotypic (P = 0.04) and fully heterotypic (P = 0.10) compared with homotypic strains (homotypic VE: 90% [95% confidence intervals (CI): 82-94]; partially heterotypic VE: 79% [95% CI: 71-85]; fully heterotypic VE: 80% [95% CI: 65-88]). In middle-income countries, RV1 VE was 14-16% lower against partially heterotypic (P = 0.06) and fully heterotypic (P = 0.04) compared with homotypic strains (homotypic VE: 81% [95% CI: 69-88]; partially heterotypic VE: 67% [95% CI: 54-76]; fully heterotypic VE: 65% [95% CI: 51-75]). Strain-specific RV5 VE differences were less pronounced, and primarily derived from high-income countries. Limited data were available from low-income countries.
CONCLUSIONS
Vaccine effectiveness of RV1 and RV5 was somewhat lower against nonvaccine than vaccine strains. Ongoing surveillance is important to continue long-term monitoring for strain replacement, particularly in low-income settings where data are limited.
Topics: Case-Control Studies; Child; Diarrhea; Hospitalization; Humans; Infant; Rotavirus; Rotavirus Infections; Rotavirus Vaccines; Vaccine Efficacy; Vaccines, Attenuated
PubMed: 34870393
DOI: 10.1097/INF.0000000000003286 -
PloS One 2020Over 34 countries in Africa have introduced rotavirus vaccine to their national immunization programs: monovalent (Rotarix®, RV1) and pentavalent (RotaTeq®, RV5) after... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Over 34 countries in Africa have introduced rotavirus vaccine to their national immunization programs: monovalent (Rotarix®, RV1) and pentavalent (RotaTeq®, RV5) after South Africa introduced it in 2009. Since then several studies assessing the impact of the vaccine have been conducted. The principal aim of this study was to evaluate the impact of rotavirus vaccine in sub-Saharan Africa.
METHODS
A Literature search was performed using Mendeley, PubMed, ScienceDirect, grey literature and Web of Science databases of published studies from January 1, 2017, as years of recent publications on rotavirus vaccine impact in sub-Saharan Africa. A meta-analysis was conducted for rotavirus infection in children under 5 years using proportions of pre and post-vaccine introduction in these populations. Random-effect estimates were considered since the samples were from universal populations.
RESULTS
Out of the 935 articles identified, 17 studies met the inclusion for systematic review and meta-analysis. The pooled proportion for pre-vaccination period was 42%, 95% (CI: 38-46%), and reduced to 21%, 95% (CI: 17-25%) during post-vaccination period. Rotavirus diarrhea significantly reduced in children < 12 months as compared to children 12-24 months old. Seasonal peaks of rotavirus diarrhea were between June-September. However, data is limited to one year of post-vaccine introduction, and bias may present due to early vaccine impact.
CONCLUSION
We observed that the introduction of the rotavirus vaccine was partly responsible for the significant reduction in the burden of rotavirus-associated diarrhea in sub-Saharan Africa. Therefore, there is a need to encourage the remaining countries to introduce the vaccine to their routine national immunization programs.
Topics: Africa South of the Sahara; Diarrhea; Humans; Immunization Programs; Rotavirus; Rotavirus Infections; Rotavirus Vaccines; Vaccination; Vaccines, Attenuated
PubMed: 32339187
DOI: 10.1371/journal.pone.0232113 -
Vaccine May 2015There are two group A rotavirus (RVA) vaccines available worldwide since 2006: monovalent (Rotarix(®), RV1) and pentavalent (RotaTeq(®), RV5). Currently, 16 countries... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
There are two group A rotavirus (RVA) vaccines available worldwide since 2006: monovalent (Rotarix(®), RV1) and pentavalent (RotaTeq(®), RV5). Currently, 16 countries and 1 territory in Latin America and the Caribbean (LAC) have introduced RVA vaccines and since their introduction several impact and effectiveness studies have been conducted in different countries. The purpose of this study was to assess RVA vaccine effectiveness in LAC countries.
METHODOLOGY
We conducted a systematic review and meta-analysis of studies in children under-five who were admitted with laboratory-confirmed RVA diarrhea. We searched Medline, WOS, LILACS, Scopus, and other sources from 2006 to October 2013. Two independent evaluators identified the studies that met predefined selection criteria and extracted relevant information according to a protocol. Pooled estimates were obtained with fixed and random-effects models and stratified according to selected effect modifiers.
RESULTS
Of the 806 articles meeting the initial criteria, 8 case-control studies which involved 27,713 participants (6265 cases and 21,448 controls) were included in the final analyses. The pooled estimates were calculated using different types of controls, leading to different degrees of effectiveness. The effectiveness of two doses of RV1 against rotavirus-related hospitalizations ranged from 63.5% (95% CI: 39.2-78.0) to 72.2% (95%CI: 60.9-80.2). Effectiveness ranged from 75.4% (95%CI: 64.6-82.9) to 81.8% (CI 95%:72.3-88.1) among infants <12 months for RV1, and from 56.5% (95%CI: 26.2-74.3) to 66.4% (95%CI: 54.1-75.5) for infants >12 months. The RV5 effectiveness for diarrhea with a Vesikari score >11 in infants 6 to 11 months old ranged from 76.1% (95%CI: 57.6-86.6) to 88.8% (95%CI: 78.3-94.3). Also, it showed 63.5% (95%CI: 29.4-82.6) of effectiveness against G2P [4].
CONCLUSION
RVA vaccines consistently showed protection against diarrhea-related hospitalizations in LAC. Results were more robust for RV1. Effectiveness was shown with different types of controls, but appeared somewhat higher with community controls. Effectiveness was higher among infants <12 months and lower in older children.
Topics: Age Factors; Caribbean Region; Diarrhea; Hospitalization; Humans; Latin America; Rotavirus Infections; Rotavirus Vaccines; Treatment Outcome; Vaccines, Attenuated
PubMed: 25919169
DOI: 10.1016/j.vaccine.2014.11.060 -
Open Forum Infectious Diseases 2017Rotavirus vaccine schedules may impact vaccine response among children in low- and middle-income countries (LMICs). Our objective was to review the literature evaluating... (Review)
Review
BACKGROUND
Rotavirus vaccine schedules may impact vaccine response among children in low- and middle-income countries (LMICs). Our objective was to review the literature evaluating the effects of monovalent (RV1) or pentavalent rotavirus vaccines schedules on vaccine response.
METHODS
We searched PubMed, Web of Science, Embase, and ClinicalTrials.gov for eligible trials conducted in LMICs comparing ≥2 vaccine schedules and reporting immunologic response or efficacy. We calculated seroconversion proportion differences and geometric mean concentration (GMC) ratios with 95% confidence intervals.
RESULTS
We abstracted data from 8 eligible trials of RV1. The point estimates for seroconversion proportions difference ranged from -0.25 to -0.09 for the 6/10-week schedule compared with 10/14. The range for the 6/10/14- compared with 10/14-week schedule was -0.02 to 0.10. Patterns were similar for GMC ratios and efficacy estimates.
CONCLUSIONS
The commonly used 6/10-week RV1 schedule in LMICs may not be optimal. Further research on the effect of rotavirus schedules using clinical endpoints is essential.
PubMed: 28567431
DOI: 10.1093/ofid/ofx066 -
Vaccine Jun 2021Understanding the safety of vaccines is critical to inform decisions about vaccination. Our objective was to conduct a systematic review of the safety of vaccines... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Understanding the safety of vaccines is critical to inform decisions about vaccination. Our objective was to conduct a systematic review of the safety of vaccines recommended for children, adults, and pregnant women in the United States.
METHODS
We searched the literature in November 2020 to update a 2014 Agency for Healthcare Research and Quality review by integrating newly available data. Studies of vaccines that used a comparator and reported the presence or absence of key adverse events were eligible. Adhering to Evidence-based Practice Center methodology, we assessed the strength of evidence (SoE) for all evidence statements. The systematic review is registered in PROSPERO (CRD42020180089).
RESULTS
Of 56,603 reviewed citations, 338 studies reported in 518 publications met inclusion criteria. For children, SoE was high for no increased risk of autism following measles, mumps, and rubella (MMR) vaccine. SoE was high for increased risk of febrile seizures with MMR. There was no evidence of increased risk of intussusception with rotavirus vaccine at the latest follow-up (moderate SoE), nor of diabetes (high SoE). There was no evidence of increased risk or insufficient evidence for key adverse events for newer vaccines such as 9-valent human papillomavirus and meningococcal B vaccines. For adults, there was no evidence of increased risk (varied SoE) or insufficient evidence for key adverse events for the new adjuvanted inactivated influenza vaccine and recombinant adjuvanted zoster vaccine. We found no evidence of increased risk (varied SoE) for key adverse events among pregnant women following tetanus, diphtheria, and acellular pertussis vaccine, including stillbirth (moderate SoE).
CONCLUSIONS
Across a large body of research we found few associations of vaccines and serious key adverse events; however, rare events are challenging to study. Any adverse events should be weighed against the protective benefits that vaccines provide.
Topics: Adult; Child; Diphtheria; Female; Humans; Infant; Measles; Measles-Mumps-Rubella Vaccine; Mumps; Pregnancy; United States; Vaccination
PubMed: 34049735
DOI: 10.1016/j.vaccine.2021.03.079 -
Open Forum Infectious Diseases Nov 2018Gastroenteritis caused by rotavirus accounts for considerable morbidity in young children. We aimed to assess the vaccine effectiveness (VE) of the oral rotavirus... (Review)
Review
BACKGROUND
Gastroenteritis caused by rotavirus accounts for considerable morbidity in young children. We aimed to assess the vaccine effectiveness (VE) of the oral rotavirus vaccine , as measured by laboratory-confirmed rotavirus infection after referral to hospital and/or emergency departments in children aged <5 years with gastroenteritis.
METHODS
We performed a systematic search for peer-reviewed studies conducted in real-life settings published between 2006 and 2016 and a meta-analysis to calculate the overall VE, which was further discriminated through stratified analyses.
RESULTS
The overall VE estimate was 69% (95% confidence interval [CI], 62% to 75%); stratified analyses revealed a non-negligible impact of factors such as study design and socioeconomic status. Depending on the control group, VE ranged from 63% (95% CI, 52% to 72%) to 81% (95% CI, 69% to 88%) for unmatched and matched rotavirus test-negative controls. VE varied with socioeconomic status: 81% (95% CI, 74% to 86%) in high-income countries, 54% (95% CI, 39% to 65%) in upper-middle-income countries, and 63% (95% CI, 50% to 72%) in lower-middle-income countries. Age, rotavirus strain, and disease severity were also shown to impact VE, but to a lesser extent.
CONCLUSIONS
This meta-analysis of real-world studies showed that is effective in helping to prevent hospitalizations and/or emergency department visits due to rotavirus infection.
PubMed: 30539038
DOI: 10.1093/ofid/ofy292 -
Open Forum Infectious Diseases Apr 2019Rotavirus causes morbidity and mortality in children particularly in low-income countries (LICs) and lower-middle-income countries (LMICs). This systematic review and...
BACKGROUND
Rotavirus causes morbidity and mortality in children particularly in low-income countries (LICs) and lower-middle-income countries (LMICs). This systematic review and meta-analysis aimed to assess cost-effectiveness of rotavirus vaccine in LICs and LMICs.
METHODS
Relevant studies were identified from PubMed and Scopus from their inception to January 2019. Studies were eligible if they assessed the cost-effectiveness of rotavirus vaccine in children in LICs and LMICs and reported incremental cost-effectiveness ratios. Risk of bias and quality assessment was assessed based on the Consolidated Health Economic Evaluation Reporting Standard checklist. Incremental net benefits (INBs) were estimated, and meta-analysis based on the DerSimonian and Laird method was applied to pool INBs across studies.
RESULTS
We identified 1614 studies, of which 28 studies (29 countries) were eligible and conducted using cost-utility analysis in LICs (n = 8) and LMICs (n = 21). The pooled INB was estimated at $62.17 (95% confidence interval, $7.12-$117.21) in LICs, with a highly significant heterogeneity (χ = 33.96; = 6; < .001; = 82.3%), whereas the pooled INB in LMICs was $82.46 (95% confidence interval, $54.52-$110.41) with no heterogeneity (χ = 8.46; = 11; = .67; = 0%).
CONCLUSIONS
Rotavirus vaccine would be cost-effective to introduce in LICs and LMICs. These findings could aid decision makers and provide evidence for introduction of rotavirus vaccination.
PubMed: 31049363
DOI: 10.1093/ofid/ofz117 -
Vaccine Aug 2023This systematic review presents cost-effectiveness studies of rotavirus vaccination in high-income settings based on dynamic transmission modelling to inform policy... (Review)
Review
PURPOSE
This systematic review presents cost-effectiveness studies of rotavirus vaccination in high-income settings based on dynamic transmission modelling to inform policy decisions about implementing rotavirus vaccination programmes.
METHODS
We searched CEA Registry, MEDLINE, Embase, Health Technology Assessment Database, Scopus, and the National Health Service Economic Evaluation Database for studies published since 2002. Full economic evaluation studies based on dynamic transmission models, focusing on high-income countries, live oral rotavirus vaccine and children ≤ 5 years of age were eligible for inclusion. Included studies were appraised for quality and risk of bias using the Consensus on Health Economic Criteria (CHEC) list and the Philips checklist. The review protocol was prospectively registered with PROSPERO (CRD42020208406).
RESULTS
A total of four economic evaluations were identified. Study settings included England and Wales, France, Norway, and the United States. All studies compared either pentavalent or monovalent rotavirus vaccines to no intervention. All studies were cost-utility analyses that reported incremental cost per quality-adjusted life year (QALY) gained. Included studies consistently concluded that rotavirus vaccination is cost-effective compared with no vaccination relative to the respective country's willingness to pay threshold when herd protection benefits are incorporated in the modelling framework.
CONCLUSIONS
Rotavirus vaccination was found to be cost-effective in all identified studies that used dynamic transmission models in high-income settings where child mortality rates due to rotavirus gastroenteritis are close to zero. Previous systematic reviews of economic evaluations considered mostly static models and had less conclusive findings than the current study. This review suggests that modelling choices influence cost-effectiveness results for rotavirus vaccination. Specifically, the review suggests that dynamic transmission models are more likely to account for the full impact of rotavirus vaccination than static models in cost-effectiveness analyses.
Topics: Child; Humans; Cost-Benefit Analysis; Rotavirus; State Medicine; Vaccination; Rotavirus Infections; Rotavirus Vaccines
PubMed: 37479614
DOI: 10.1016/j.vaccine.2023.06.064 -
EClinicalMedicine Dec 2022Oral rotavirus vaccines have lower effectiveness in high child mortality settings. We evaluated the impact of additional dose(s) schedules of rotavirus vaccine on...
BACKGROUND
Oral rotavirus vaccines have lower effectiveness in high child mortality settings. We evaluated the impact of additional dose(s) schedules of rotavirus vaccine on vaccine immunogenicity and reduction in episodes of gastroenteritis.
METHODS
We searched Medline (via PubMed), Cochrane databases and ClinicalTrials.gov for randomised controlled trials from 1973 to February 2022, evaluating the immunological and clinical impact of additional dose vs standard dose oral rotavirus vaccine schedules. We extracted immunogenicity - proportion of children with evidence of anti-rotavirus IgA seroresponse, and clinical - proportion of children with at least one episode of severe rotavirus gastroenteritis, outcome data and used random effects meta-analysis where appropriate. We assessed the methodological quality of the studies using the Cochrane risk of bias tool. The study protocol was registered in PROSPERO (CRD42021261058).
FINDINGS
We screened 536 items and included 7 clinical trials. Our results suggest moderate to high level evidence that an additional dose rotavirus vaccine schedule improves IgA vaccine immune response, including additional doses administered as a booster dose schedule >6 months old; IgA vaccine seroresponse 74·3% additional dose schedule vs 56·1% standard dose schedule RR 1·3 (95%CI, 1·15 - 1·48), and when administered to children who were seronegative at baseline; IgA vaccine seroresponse 48.2% additional dose schedule vs 29.6% standard dose schedule RR 1.86 (95%CI 1.27 to 2.72). Only one study evaluated reduction in gastroenteritis episodes and found little benefit in first year of life, 1·8% vs 2·0% RR 0·88 (95% CI, 0·52 to 1·48), or second year of life, 1·7% vs 2·9% RR 0·62 (95%CI, 0·31 - 1·23).
INTERPRETATION
Administering an additional dose of oral rotavirus vaccines is likely to result in an improved vaccine immune response, including when administered as a booster dose to older children. Evidence of an impact on diarrhoeal disease is needed before additional dose rotavirus vaccine schedules can be recommended as vaccine policy.
FUNDING
BM was funded by the National Health and Medical Research Council, the Royal Australasian College of Physicians Paediatrics and Child Health Division, and the Australian Academy of Science.
PubMed: 36247922
DOI: 10.1016/j.eclinm.2022.101687