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BMC Infectious Diseases Aug 2017Rotavirus was the leading cause of acute gastroenteritis (AGE) in infants and young children prior to the introduction of routine vaccination. Since 2006 there have been... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Rotavirus was the leading cause of acute gastroenteritis (AGE) in infants and young children prior to the introduction of routine vaccination. Since 2006 there have been two licensed vaccines available; with successful clinical trials leading the World Health Organization to recommend rotavirus vaccination for all children worldwide. In order to inform immunisation policy we have conducted a systematic review and meta-analysis of observation studies to assess population effectiveness against acute gastroenteritis.
METHODS
We systematically searched PubMed, Medline, Web of Science, Cinhal and Academic Search Premier and grey literature sources for studies published between January 2006 and April 2014. Studies were eligible for inclusion if they were observational measuring population effectiveness of rotavirus vaccination against health care attendances for rotavirus gastroenteritis or AGE. To evaluate study quality we use used the Newcastle-Ottawa Scale for non-randomised studies, categorising studies by risk of bias. Publication bias was assessed using funnel plots. If two or more studies reported a measure of vaccine effectiveness (VE), we conducted a random effects meta-analysis. We stratified analyses by World Bank country income level and used study quality in sensitivity analyses.
RESULTS
We identified 30 studies, 19 were from high-income countries and 11 from middle-income countries. Vaccine effectiveness against hospitalization for laboratory confirmed rotavirus gastroenteritis was highest in high-income countries (89% VE; 95% CI 84-92%) compared to middle-income countries (74% VE; 95% CI 67-80%). Vaccine effectiveness was higher for those receiving the complete vaccine schedule (81% VE; 95% CI 75-86%) compared to partial schedule (62% VE; 95% CI 55-69%). Two studies from high-income countries measured VE against community consultations for AGE with a pooled estimate of 40% (95% CI 13-58%; 2 studies).
CONCLUSIONS
We found strong evidence to further support the continued use of rotavirus vaccines. Vaccine effectiveness was similar to that reported in clinical trials for both high and middle-income countries. There is limited data from Low income settings at present. There was lower effectiveness against milder disease. Further studies, should continue to report effectiveness against AGE and less-severe rotavirus disease because as evidenced by pre-vaccine introduction studies this is likely to contribute the greatest burden on healthcare resources, particularly in high-income countries.
Topics: Developed Countries; Developing Countries; Gastroenteritis; Hospitalization; Humans; Immunization Schedule; Infant; Observational Studies as Topic; Rotavirus Infections; Rotavirus Vaccines; Vaccination; Vaccines, Attenuated
PubMed: 28810833
DOI: 10.1186/s12879-017-2613-4 -
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 May 2017To describe and systematically review the modelling and reporting of cost-effectiveness analysis of vaccination in Hong Kong, and to identify areas for quality... (Review)
Review
OBJECTIVES
To describe and systematically review the modelling and reporting of cost-effectiveness analysis of vaccination in Hong Kong, and to identify areas for quality enhancement in future cost-effectiveness analyses.
METHODS
We conducted a comprehensive and systematic review of cost-effectiveness studies related to vaccination and government immunisation programmes in Hong Kong published from 1990 to 2015, through database search of Pubmed, Web of Science, Embase, and OVID Medline. Methodological quality of selected studies was assessed using Consolidated Health Economic Evaluation Reporting Standards checklist (CHEERS). Decision making of vaccination was obtained from Scientific Committee on Vaccine Preventable Diseases (SCVPD) and Department of Health in Hong Kong.
RESULTS
Nine eligible studies reporting twelve comparative cost-effectiveness comparisons of vaccination programme for influenza (n=2), pneumococcal disease (n=3), influenza plus pneumococcal disease (n=1), chickenpox (n=2), Haemophilus influenzae b (n=1), hepatitis A (n=1), cervical cancer (n=1) and rotavirus (n=1) were identified. Ten comparisons (83.3%) calculated the incremental cost-effectiveness ratio (ICER) of a vaccination strategy versus status quo as outcomes in terms of cost in USD per life-years, cost per quality-adjusted life-years, or cost per disability-adjusted life-years. Among those 10 comparisons in base-case scenario, 4 evaluated interventions were cost-saving relative to status quo while the ICER estimates in 3 of the 6 remaining comparisons were far below commonly accepted threshold and WHO willingness-to-pay threshold, suggestive of very cost-effective. Seven studies were of good quality based on the CHEERS checklist; one was of moderate quality; and one was of excellent quality. The common methodological problems were characterisation of heterogeneity and reporting of study parameters.
CONCLUSIONS
There was a paucity of cost-effectiveness models evaluating vaccination targeted to the Hong Kong population. All evaluated vaccinations and immunisation interventions in Hong Kong, except for Haemophilus influenzae b, hepatitis A and HPV vaccinations, were considered either cost-saving or very cost-effective when compared to status quo.
Topics: Adolescent; Aged; Child; Child, Preschool; Clinical Decision-Making; Cost-Benefit Analysis; Female; Hepatitis A; Hong Kong; Humans; Immunization Programs; Infant; Influenza Vaccines; Influenza, Human; Male; Papillomavirus Vaccines; Pneumococcal Infections; Quality-Adjusted Life Years; Uterine Cervical Neoplasms; Vaccination; Viral Hepatitis Vaccines
PubMed: 28476628
DOI: 10.1016/j.vaccine.2017.04.050 -
Vaccine Mar 2017Live vaccines are generally contraindicated on immunosuppressive therapy due to safety concerns. However, data are limited to corroborate this practice. (Review)
Review
Safety of live vaccinations on immunosuppressive therapy in patients with immune-mediated inflammatory diseases, solid organ transplantation or after bone-marrow transplantation - A systematic review of randomized trials, observational studies and case reports.
BACKGROUND
Live vaccines are generally contraindicated on immunosuppressive therapy due to safety concerns. However, data are limited to corroborate this practice.
OBJECTIVES
To estimate the safety of live vaccinations in patients with immune-mediated inflammatory diseases (IMID) or solid organ transplantation (SOT) on immunosuppressive treatment and in patients after bone-marrow transplantation (BMT).
DATA SOURCES
A search was conducted in electronic databases (Cochrane, Pubmed, Embase) and additional literature was identified by targeted searches.
ELIGIBILITY CRITERIA
Randomized trials, observational studies and case reports.
POPULATION
Patients with IMID or SOT on immunosuppressive treatment and BMT patients <2years after transplantation.
INTERVENTION/VACCINATIONS LOOKED AT
Live vaccinations: mumps, measles, rubella (MMR), yellow fever (YF), varicella vaccine (VV), herpes zoster (HZ), oral typhoid, oral polio, rotavirus, Bacillus Calmette-Guérin (BCG), smallpox.
DATA EXTRACTION
One author performed the data extraction using predefined data fields. It was cross-checked by two other authors.
RESULTS
7305 articles were identified and 64 articles were included: 40 on IMID, 16 on SOT and 8 on BMT patients. In most studies, the administration of live vaccines was safe. However, some serious vaccine-related adverse events occurred. 32 participants developed an infection with the vaccine strain; in most cases the infection was mild. However, in two patients fatal infections were reported: a patient with RA/SLE overlap who started MTX/dexamethasone treatment four days after the YFV developed a yellow fever vaccine-associated viscerotropic disease (YEL-AVD) and died. The particular vaccine lot was found to be associated with a more than 20 times risk of YEL-AVD. One infant whose mother was under infliximab treatment during pregnancy received the BCG vaccine at the age of three months and developed disseminated BCG infection and died. An immunogenicity assessment was performed in 43 studies. In most cases the patients developed satisfactory seroprotection rates. In the IMID group, YFV and VV demonstrated high seroconversion rates. MTX and tumor necrosis factor inhibitory therapy appeared to reduce immune responses to VV and HZ vaccine, but not to MMR and YF-revaccination. Seroconversion in SOT and BMT patients showed mostly higher rates for rubella than for measles, mumps and varicella.
LIMITATIONS
Risk of bias was high in the majority of studies since 39 of them were observational and 17 were case series/case reports. Only eight studies were randomized trials. BMT patient numbers included in this review were low.
CONCLUSIONS
Although live vaccinations were safe and sufficiently immunogenic in most studies, some serious reactions and vaccine-related infections were reported in immunosuppressed IMID and SOT patients. Apart from mild vaccine-related infections MMR and VV vaccines were safe when administered less than two years after BMT.
IMPLICATIONS OF KEY FINDINGS
Until further data are available, live vaccinations under most immunosuppressive treatments should only be administered after a careful risk benefit assessment of medications and dosages.
FUNDING
None.
Topics: Bone Marrow Transplantation; Chickenpox; Chickenpox Vaccine; Female; Humans; Immune System Diseases; Immunosuppressive Agents; Infant; Inflammation; Male; Measles; Measles-Mumps-Rubella Vaccine; Mumps; Observational Studies as Topic; Organ Transplantation; Pregnancy; Randomized Controlled Trials as Topic; Rubella; Vaccination; Vaccines, Attenuated; Vaccines, Combined; Yellow Fever; Yellow Fever Vaccine
PubMed: 28162821
DOI: 10.1016/j.vaccine.2017.01.048 -
BMC Pediatrics Jan 2017RotaTeq™ (RV5; Merck & Co. Inc., USA) and Rotarix™ (RV1, GlaxoSmithKline, Belgium) vaccines, developed to prevent rotavirus diarrhea in children under five years... (Meta-Analysis)
Meta-Analysis Review
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.
Topics: Caribbean Region; Humans; Latin America; Models, Statistical; Rotavirus Infections; Rotavirus Vaccines; Treatment Outcome; Vaccines, Attenuated
PubMed: 28086819
DOI: 10.1186/s12887-016-0771-y -
Infectious Diseases of Poverty Aug 2016Rotavirus was the leading cause of childhood diarrhoea-related hospitalisations and death before the introduction of rotavirus vaccines. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Rotavirus was the leading cause of childhood diarrhoea-related hospitalisations and death before the introduction of rotavirus vaccines.
METHODS
We describe the effectiveness of rotavirus vaccines to prevent rotavirus infections and hospitalizations and the main rotavirus strains circulating before and after vaccine introduction through a systematic review and meta-analysis of studies published between 1990 and 2014. 203 studies were included to estimate the proportion of infections due to rotavirus and 10 to assess the impact of the vaccines. 41 of 46 studies in the post-vaccination period were used for meta-analysis of genotypes, 20 to calculate VE against infection, eight for VE against hospitalisation and seven for VE against severe rotavirus-diarrhoea.
RESULTS
24.3 % (95 % CI 22.1-26.5) and 16.1 % (95 % CI 13.2-19.3) of cases of diarrhoea were due to rotavirus before and after vaccine introduction, respectively. The most prevalent G types after vaccine introduction were G2 (51.6 %, 95 % CI 38-65), G9 (14.5 %, 95 % CI 7-23) and G1 (14.2 %, 95 % CI 7-23); while the most prevalent P types were P[4] (54.1 %, 95 % CI 41-67) and P[8] (33 %, 95 % CI 22-46). G2P[4] was the most frequent genotype combination after vaccine introduction. Effectiveness was 53 % (95 % CI 46-60) against infection, 73 % (95 % CI, 66-78) against hospitalisation and 74 % (95 % CI, 68.0-78.0) against severe diarrhoea. Reductions in hospitalisations and mortality due to diarrhoea were observed in countries that adopted universal rotavirus vaccination.
CONCLUSIONS
Rotavirus vaccines are effective in preventing rotavirus-diarrhoea in children in Latin America. The vaccines were associated with changes in genotype distribution.
Topics: Child, Preschool; Diarrhea; Genotype; Hospitalization; Humans; Infant; Infant, Newborn; Latin America; Prevalence; Rotavirus; Rotavirus Infections; Rotavirus Vaccines
PubMed: 27514855
DOI: 10.1186/s40249-016-0173-2 -
Human Vaccines & Immunotherapeutics May 2016This study compared the economic value of pediatric immunisation programmes for influenza to those for rotavirus (RV), meningococcal disease (MD), pneumococcal disease... (Comparative Study)
Comparative Study Review
This study compared the economic value of pediatric immunisation programmes for influenza to those for rotavirus (RV), meningococcal disease (MD), pneumococcal disease (PD), human papillomavirus (HPV), hepatitis B (Hep B), and varicella reported in recent (2000 onwards) cost-effectiveness (CE) studies identified in a systematic review of PubMed, health technology, and vaccination databases. The systematic review yielded 51 economic evaluation studies of pediatric immunisation - 10 (20%) for influenza and 41 (80%) for the other selected diseases. The quality of the eligible articles was assessed using Drummond's checklist. Although inherent challenges and limitations exist when comparing economic evaluations of immunisation programmes, an overall comparison of the included studies demonstrated cost-effectiveness/cost saving for influenza from a European-Union-Five (EU5) and United States (US) perspective; point estimates for cost/quality-adjusted life-years (QALY) from dominance (cost-saving with more effect) to ≤45,444 were reported. The economic value of influenza programmes was comparable to the other vaccines of interest, with cost/QALY in general considerably lower than RV, Hep B, MD and PD. Independent of the perspective and type of analysis, the economic impact of a pediatric influenza immunisation program was influenced by vaccine efficacy, immunisation coverage, costs, and most significantly by herd immunity. This review suggests that pediatric influenza immunisation may offer a cost effective strategy when compared with HPV and varicella and possibly more value compared with other childhood vaccines (RV, Hep B, MD and PD).
Topics: Adolescent; Chickenpox Vaccine; Child; Child, Preschool; Cost-Benefit Analysis; Europe; Female; Hepatitis B Vaccines; Humans; Immunity, Herd; Immunization Programs; Infant; Influenza Vaccines; Influenza, Human; Male; Meningococcal Vaccines; Papillomavirus Vaccines; Pneumococcal Infections; Pneumococcal Vaccines; Quality-Adjusted Life Years; Rotavirus Vaccines; United States
PubMed: 26837602
DOI: 10.1080/21645515.2015.1131369 -
Value in Health : the Journal of the... Jan 2016To investigate the use of patient-reported outcomes (PROs) in pediatric populations with vaccine-preventable infectious diseases in high-income Western countries. (Review)
Review
OBJECTIVE
To investigate the use of patient-reported outcomes (PROs) in pediatric populations with vaccine-preventable infectious diseases in high-income Western countries.
METHODS
Systematic review of PRO use in populations younger than 18 years with any of 17 infectious diseases for which vaccines are available or in development. The search was limited to studies performed in Europe, North America, Australia, and New Zealand and published between January 1, 1990, and July 31, 2013. Searches were conducted in Scopus and PsycINFO, and reference lists were manually searched. Results are reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
RESULTS
Of 6410 titles and abstracts and 174 full-text articles reviewed, 17 full-text articles were included for data extraction. The largest number of PRO studies was carried out in patients with anogenital warts and rotavirus gastroenteritis. No PRO studies were identified for nine conditions. A total of 24 PRO measures (12 generic and 12 disease-specific) were used in the studies reviewed. Most of the instruments used were of high quality. Proxy responses were occasionally obtained when self-report would have been feasible. No validated disease-specific instruments for children with any of the conditions studied were found.
CONCLUSIONS
The paucity of studies and PRO instruments to assess pediatric health status in vaccine-preventable infectious diseases, and the lack of a standardized approach to measurement, makes it difficult to capture the impact of disease and the benefit of vaccination and could potentially hinder decision making. Guidelines from relevant bodies to steer research in this area would be useful.
Topics: Adolescent; Child; Child, Preschool; Communicable Diseases; Female; Humans; Infant; Male; Patient Outcome Assessment; Self Report; Vaccines
PubMed: 26797243
DOI: 10.1016/j.jval.2015.10.001 -
Clinical Infectious Diseases : An... Jan 2016Norovirus and rotavirus are prominent enteric viruses responsible for severe acute gastroenteritis disease burden around the world. Both viruses recognize and bind to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Norovirus and rotavirus are prominent enteric viruses responsible for severe acute gastroenteritis disease burden around the world. Both viruses recognize and bind to histo-blood group antigens, which are expressed by the fucosyltransferase 2 (FUT2) gene. Individuals with a functional FUT2 gene are termed "secretors." FUT2 polymorphisms may influence viral binding patterns and, therefore, may influence host susceptibility to infection by these viruses.
METHODS
We performed a systematic review of the published literature on this topic. Data were abstracted and compiled for descriptive analyses and metaanalyses. We estimated pooled odds ratios (ORs) for infection using random-effects models.
RESULTS
We found that secretors were 9.9 times (95% confidence interval [CI], 3.9-24.8) as likely to be infected with genogroup II.4 noroviruses and 2.2 times as likely to be infected with genogroup II non-4 noroviruses (95% CI, 1.2-4.2) compared with nonsecretors. Secretors were also 26.6 times more susceptible to infections from P[8]-type rotaviruses compared with nonsecretors (95% CI, 8.3-85.0).
CONCLUSIONS
Our analyses indicate that host genetic susceptibility to norovirus and rotavirus infection may be strain specific. As strain distribution and the proportion of genetic phenotypes vary in different countries, future studies should focus on differences in susceptibility among various ethnicities. Knowledge of innate susceptibility to rotavirus and norovirus can lead to improved understanding of both vaccine performance and individual risk of disease.
Topics: Caliciviridae Infections; Fucosyltransferases; Genetic Predisposition to Disease; Humans; Norovirus; Rotavirus; Rotavirus Infections; Galactoside 2-alpha-L-fucosyltransferase
PubMed: 26508510
DOI: 10.1093/cid/civ873 -
Vaccine Jul 2015Diarrhea is one of the leading causes of death in children under 5, and an estimated 39% of these deaths are attributable to rotavirus. Currently two live, oral... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Diarrhea is one of the leading causes of death in children under 5, and an estimated 39% of these deaths are attributable to rotavirus. Currently two live, oral rotavirus vaccines have been introduced on the market; however, the herd immunity effect associated with rotavirus vaccine has not yet been quantified. The purpose of this meta-analysis was to estimate the herd immunity effects associated with rotavirus vaccines.
METHODS
We performed a systematic literature review of articles published between 2008 and 2014 that measured the impact of rotavirus vaccine on severe gastroenteritis (GE) morbidity or mortality. We assessed the quality of published studies using a standard protocol and conducted meta-analyses to estimate the herd immunity effect in children less than one year of age across all years presented in the studies. We conducted these analyses separately for studies reporting a rotavirus-specific GE outcome and those reporting an all-cause GE outcome.
RESULTS
In studies reporting a rotavirus-specific GE outcome, four of five of which were conducted in the United States, the median herd effect across all study years was 22% [19-25%]. In studies reporting an all-cause GE outcome, all of which were conducted in Latin America, the median herd effect was 24.9% [11-30%].
CONCLUSIONS
There is evidence that rotavirus vaccination confers a herd immunity effect in children under one year of age in the United States and Latin American countries. Given the high variability in vaccine efficacy across regions, more studies are needed to better examine herd immunity effects in high mortality regions.
Topics: Gastroenteritis; Humans; Immunity, Herd; Latin America; Rotavirus Infections; Rotavirus Vaccines; United States
PubMed: 26116250
DOI: 10.1016/j.vaccine.2015.06.064