Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial

Mo, Zhaojun; Yi, Mo; Li, Mingqiang; Tao, Junhui; Xu, Yang; Kong, Jilian; Wei, Dingkai; Fu, Botao; Liao, Xueyan; Chu, Jianli; Qiu, Yunfeng; Hille, Darcy A.; Nelson, Micki; Kaplan, Susan S.

doi:10.1016/j.vaccine.2017.08.081

Cited by 44 publications

(57 citation statements)

References 32 publications

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“…In the previously published version of this review there were 41 included studies. The review now includes 55 independent trials (see Characteristics of included studies), 14 of which are new to this update (RV1 Colgate 2016‐BGD; RV1 Kim 2012‐KOR; RV1 Li 2013a‐CHN; RV1 Li 2013b‐CHN; RV1 Li 2014‐CHN; RV1 NCT00158756‐RUS; RV1 Zaman 2017‐BGD; RV5 Dhingra 2014‐IND; RV5 Levin 2017‐AF; RV5 Mo 2017‐CHN; VAC Bhandari 2006‐IND; VAC Bhandari 2009‐IND; VAC Bhandari 2014‐IND; VAC Chandola 2017‐IND) and we also added another 23 new companion papers to previously included trials with this update. The review also includes 15 ongoing studies (see Characteristics of ongoing studies).…”

Section: Resultsmentioning

confidence: 99%

“…Half of the trials were conducted in low‐mortality countries in North America and Europe. Six trials, including the smallest and the largest trials, were conducted in other regions: RV5 Armah 2010‐AF was conducted in Ghana, Kenya and Mali; RV5 Levin 2017‐AF was conducted in Botswana, Tanzania, Zambia and Zimbabwe, RV5 Dhingra 2014‐IND was conducted in India, RV5 Kim 2008‐KOR was conducted in South Korea; RV5 Iwata 2013‐JPN was conducted in Japan; RV5 Lawrence 2012‐CHN and RV5 Mo 2017‐CHN were conducted in China; RV5 Vesikari 2006b‐INT was conducted in 12 countries in Asia, the Caribbean, Europe, Latin America, North America; and RV5 Zaman 2010‐AS was conducted in Bangladesh and Vietnam. Each trial had multiple sites, ranging from three (RV5 Vesikari 2006a‐FIN) to 356 sites (RV5 Vesikari 2006b‐INT); see Appendix 5.…”

Section: Resultsmentioning

confidence: 99%

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Vaccines for preventing rotavirus diarrhoea: vaccines in use

Soares‐Weiser

Pitan

Cunliffe

2019

Cochrane Database of Systematic Reviews

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BackgroundRotavirus results in more diarrhoea‐related deaths in children under five years than any other single agent in countries with high childhood mortality. It is also a common cause of diarrhoea‐related hospital admissions in countries with low childhood mortality. Rotavirus vaccines that have been prequalified by the World Health Organization (WHO) include a monovalent vaccine (RV1; Rotarix, GlaxoSmithKline), a pentavalent vaccine (RV5; RotaTeq, Merck), and, more recently, another monovalent vaccine (Rotavac, Bharat Biotech).ObjectivesTo evaluate rotavirus vaccines prequalified by the WHO (RV1, RV5, and Rotavac) for their efficacy and safety in children.Search methodsOn 4 April 2018 we searched MEDLINE (via PubMed), the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (published in the Cochrane Library), Embase, LILACS, and BIOSIS. We also searched the WHO ICTRP, ClinicalTrials.gov, clinical trial reports from manufacturers' websites, and reference lists of included studies and relevant systematic reviews.Selection criteriaWe selected randomized controlled trials (RCTs) in children comparing rotavirus vaccines prequalified for use by the WHO versus placebo or no intervention.Data collection and analysisTwo review authors independently assessed trial eligibility and assessed risks of bias. One review author extracted data and a second author cross‐checked them. We combined dichotomous data using the risk ratio (RR) and 95% confidence interval (CI). We stratified the analysis by country mortality rate and used GRADE to evaluate evidence certainty.Main resultsFifty‐five trials met the inclusion criteria and enrolled a total of 216,480 participants. Thirty‐six trials (119,114 participants) assessed RV1, 15 trials (88,934 participants) RV5, and four trials (8432 participants) Rotavac.RV1Children vaccinated and followed up the first year of lifeIn low‐mortality countries, RV1 prevents 84% of severe rotavirus diarrhoea cases (RR 0.16, 95% CI 0.09 to 0.26; 43,779 participants, 7 trials; high‐certainty evidence), and probably prevents 41% of cases of severe all‐cause diarrhoea (RR 0.59, 95% CI 0.47 to 0.74; 28,051 participants, 3 trials; moderate‐certainty evidence). In high‐mortality countries, RV1 prevents 63% of severe rotavirus diarrhoea cases (RR 0.37, 95% CI 0.23 to 0.60; 6114 participants, 3 trials; high‐certainty evidence), and 27% of severe all‐cause diarrhoea cases (RR 0.73, 95% CI 0.56 to 0.95; 5639 participants, 2 trials; high‐certainty evidence).Children vaccinated and followed up for two yearsIn low‐mortality countries, RV1 prevents 82% of severe rotavirus diarrhoea cases (RR 0.18, 95% CI 0.14 to 0.23; 36,002 participants, 9 trials; high‐certainty evidence), and probably prevents 37% of severe all‐cause diarrhoea episodes (rate ratio 0.63, 95% CI 0.56 to 0.71; 39,091 participants, 2 trials; moderate‐certainty evidence). In high‐mortality countries RV1 probably prevents 35% of severe rotavirus diarrhoea cases (RR 0.65, 95% CI 0.51 to 0.83; 13,768 participants, 2 trials; high‐certainty ev...

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Vaccines for preventing rotavirus diarrhoea: vaccines in use

Soares‐Weiser

Pitan

Cunliffe

2019

Cochrane Database of Systematic Reviews

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“…The G3 genotype is recognized as the third most predominant RVA genotype in humans mostly found in combination with P[8] [81]. RotaTeq, a pentavalent human bovine reassortment vaccine contain G3P[8] genotype in its formulation [82]. Although no direct causal link has been proven, G3 strains with different P types P[4], P[6], P[8] and P[9] have been detected in humans round the world after introduction of RVA vaccines in immunization program of many countries [83,84].…”

Section: Discussionmentioning

confidence: 99%

Molecular characterization of human group A rotavirus genotypes circulating in Rawalpindi, Islamabad, Pakistan during 2015-2016

et al. 2019

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Group A rotaviruses (RVA) are one of the major causes of acute gastroenteritis (AGE) in young children worldwide. Owing to lack of proper surveillance programs and health facilities, developing countries of Asia and Africa carry a disproportionately heavy share of the RVA disease burden. The aim of this hospital-based study was to investigate the circulation of RVA genotypes in Rawalpindi and Islamabad, Pakistan in 2015 and 2016, prior to the implementation of RVA vaccine. 639 faecal samples collected from children under 10 years of age hospitalized with AGE were tested for RVA antigen by ELISA. Among 171 ELISA positive samples, 143 were successfully screened for RT-PCR and sequencing. The prevalence of RVA was found to be 26.8% with the highest frequency (34.9%) found among children of age group 6–11 months. The most predominant circulating genotypes were G3P[8] (22.4%) followed by G12P[6] (20.3%), G2P[4] (12.6%), G1P[8] (11.9%), G9P[6] (11.9%), G3P[4] (9.1%), G1P[6] (4.2%), G9P[8] (4.2%), and G3P[6] (0.7%). A single mixed genotype G1G3P[8] was also detected. The findings of this study provide baseline data, that will help to assess if future vaccination campaigns using currently available RVA vaccine will reduce RVA disease burden and instigate evolutionary changes in the overall RVA biology. The high prevalence of RVA infections in Pakistan require to improve and strengthen the surveillance and monitoring system for RVA. This will provide useful information for health authorities in planning public health care strategies to mitigate the disease burden caused by RVA.

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“…A study in Kunming, China also found the amino acid sequence of dominant G9P[8] strains to be closely related to RotaTeq but showing a low degree of homology with LLR . A randomised, double‐blind, placebo‐controlled multicentre trial in healthy Chinese infants indicated that RotaTeq was efficacious against any severity and severe rotavirus gastroenteritis caused by any serotype and generally well‐tolerated . An economic evaluation to forecast the potential impacts of the two international vaccines compared to domestic LLR found that Rotateq and Rotarix significantly decreased incidence compared to LLR, particularly among infants aged 6 months to 2 years .…”

Section: Discussionmentioning

confidence: 99%