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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 -
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 -
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 -
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 -
BMJ Clinical Evidence Jul 2011Acute gastroenteritis results from infection of the gastrointestinal tract, most commonly with a virus. It is characterised by rapid onset of diarrhoea with or without... (Review)
Review
INTRODUCTION
Acute gastroenteritis results from infection of the gastrointestinal tract, most commonly with a virus. It is characterised by rapid onset of diarrhoea with or without vomiting, nausea, fever, and abdominal pain. Diarrhoea is defined as the frequent passage of unformed, liquid stools. Regardless of the cause, the mainstay of management of acute gastroenteritis is provision of adequate fluids to prevent and treat dehydration.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions to prevent acute gastroenteritis in children? What are the effects of treatments for acute gastroenteritis in children? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 42 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review, we present information relating to the effectiveness and safety of: rotavirus vaccines for the prevention of gastroenteritis; enteral rehydration solutions (oral or gastric), lactose-free feeds, loperamide, probiotics, and zinc for the treatment of gastroenteritis; and ondansetron for the treatment of vomiting.
Topics: Acute Disease; Administration, Oral; Child; Dehydration; Gastroenteritis; Humans; Incidence; Infant; Loperamide; Nausea; Probiotics; Time Factors
PubMed: 21791124
DOI: No ID Found -
BMJ Clinical Evidence Sep 2009Acute gastroenteritis results from infection of the gastrointestinal tract, most commonly with a virus. It is characterised by rapid onset of diarrhoea with or without... (Review)
Review
INTRODUCTION
Acute gastroenteritis results from infection of the gastrointestinal tract, most commonly with a virus. It is characterised by rapid onset of diarrhoea with or without vomiting, nausea, fever, and abdominal pain. Diarrhoea is defined as the frequent passage of unformed, liquid stools. Regardless of the cause, the mainstay of management of acute gastroenteritis is provision of adequate fluids to prevent and treat dehydration.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions to prevent acute gastroenteritis in children? What are the effects of treatments for acute gastroenteritis in children? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2007 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 20 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review, we present information relating to the effectiveness and safety of: rotavirus vaccines for the prevention of gastroenteritis; enteral rehydration solutions (oral or gastric), lactose-free feeds, and loperamide for the treatment of gastroenteritis; and ondansetron for the treatment of vomiting.
Topics: Acute Disease; Administration, Oral; Child; Diarrhea; Gastroenteritis; Humans; Incidence; Infant; Rehydration Solutions; Rotavirus Infections; Rotavirus Vaccines
PubMed: 21726481
DOI: No ID Found -
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 -
Cost Effectiveness and Resource... 2018Cost-effectiveness analysis (CEA) is frequently used as an input for guiding priority setting in health. However, CEA seldom incorporates information about trade-offs... (Review)
Review
BACKGROUND
Cost-effectiveness analysis (CEA) is frequently used as an input for guiding priority setting in health. However, CEA seldom incorporates information about trade-offs between total health gains and equity impacts of interventions. This study investigates to what extent equity considerations have been taken into account in CEA in low- and middle-income countries (LMICs), using rotavirus vaccination as a case study.
METHODS
Specific equity-related indicators for vaccination were first mapped to the Guidance on Priority Setting in Health Care (GPS-Health) checklist criteria. Economic evaluations of rotavirus vaccine in LMICs identified via a systematic review of the literature were assessed to explore the extent to which equity was considered in the research objectives and analysis, and whether it was reflected in the evaluation results.
RESULTS
The mapping process resulted in 18 unique indicators. Under the 'disease and intervention' criteria, severity of illness was incorporated in 75% of the articles, age distribution of the disease in 70%, and presence of comorbidities in 5%. For the 'social groups' criteria, relative coverage reflecting wealth-based coverage inequality was taken into account in 30% of the articles, geographic location in 27%, household income level in 8%, and sex at birth in 5%. For the criteria of 'protection against the financial and social effects of ill health', age weighting was incorporated in 43% of the articles, societal perspective in 58%, caregiver's loss of productivity in 45%, and financial risk protection in 5%. Overall, some articles incorporated the indicators in their model inputs (20%) while the majority (80%) presented results (costs, health outcomes, or incremental cost-effectiveness ratios) differentiated according to the indicators. Critically, less than a fifth (17%) of articles incorporating indicators did so due to an explicit study objective related to capturing equity considerations. Most indicators were increasingly incorporated over time, with a notable exception of age-weighting of DALYs.
CONCLUSION
Integrating equity criteria in CEA can help policy-makers better understand the distributional impact of health interventions. This study illustrates how equity considerations are currently being incorporated within CEA of rotavirus vaccination and highlights the components of equity that have been used in studies in LMICs. Areas for further improvement are identified.
PubMed: 29796012
DOI: 10.1186/s12962-018-0102-2