Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China

Li, Rongcheng; Li, Yanping; Mo, Zhaojun; Luo, Dong; Huang, Teng; Kong, Jilian; Wang, Lao-Hong; Song, Ning-Sheng; Liu, Aixue; Zhang, Baiyu; Liao, Xueyan; Karkada, Naveen; Han, Htay Htay

doi:10.4161/hv.25076

“…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%

“…Most trials included healthy infants. Two trials included HIV‐infected or ‐exposed infants (RV1 Madhi 2010‐AF; RV1 Steele 2010a‐ZAF), one trial included premature infants (RV1 Omenaca 2012‐EU), and one trial included children aged two to six years (RV1 Li 2013a‐CHN).…”

Section: Resultsmentioning

confidence: 99%

Vaccines for preventing rotavirus diarrhoea: vaccines in use

Soares‐Weiser

¹

,

Pitan

²

,

Cunliffe

³

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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“…This study showed that the efficacy rate of vaccine against the G1 wild-type was 81%-82%, against the pooled non-G1 strain was 78%, against the non-G1P [8] strain was 81%, against hospitalization with severe diarrhea was 83%, and against hospitalization with any cause was 39%. [71] The vaccine has also been tested in China and Hong Kong, [54,55] with an efficacy rate of 87%-96% against hospitalization…”

Section: Monovalent Human G1 Rotavirus Vaccinementioning

confidence: 99%

“…[47] The efficacy of major human rotavirus vaccines in different settings is shown in the Table. [36,[47][48][49][50][51][52][53][54][55][56][57][58][59] Trials [47,60,61] showed that the efficacy of RotaTeq on diarrheal diseases and severe gastroenteritis was 74% and 98%, respectively. RotaTeq was also effective in combating each of the common circulating serotypes.…”

Section: Human-bovine Rotavirus Reassortant Vaccinementioning

confidence: 99%

“…Years reported Countries and areas Effi cacy on conditions Effi cacy, % (95% CI) RotaShield [48] Rotarix [51] 2009 Singapore Severe RVGE 96 (85-100) Rotarix [52] 2010 Malawi, South Africa Severe RVGE 61 (44-73) Rotarix [53] 2013 USA RVGE of any severity 91 (80-95) Rotarix [54] 2013 China Seroconversion rate 87 (60-98) Rotarix [55] 2013 Hong Kong, China RVGE of any severity 96 (73-100) RotaTeq [56] 2009 Europe Severe RVGE 68 (60-74) RotaTeq [57] 2010 Ghana, Kenya, Mali RVGE of any severity 31 (17-42) Severe RVGE 39 (19-55) RotaTeq [58] 2010 Bangladesh, Vietnam RVGE of any severity 43 (21-58) Severe RVGE 48 (22-66) RotaTeq [59] 2013 Japan Severe RVGE 100 (55-100) RotaTeq [53] 2013 USA RVGE of any severity 92 (75-97) innate and acquired virus-specific humoral and cellular immune antibody. [79,80] The mechanism of immune responses, by which protection from rotavirus infection occurs after natural infection or after immunization, is unknown.…”

Section: Rotavirus Infection or Rotavirus Vaccination Induces Vaccinementioning

confidence: 99%

See 1 more Smart Citation

Current status of rotavirus vaccines

Wang

¹

,

Chen²,

Chen

³

2015

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Vaccines for preventing rotavirus diarrhoea: vaccines in use

Soares‐Weiser

¹

,

Bergman

²

,

Henschke

³

et al. 2019

Cochrane Database of Systematic Reviews

View full text Add to dashboard Cite

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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Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China

Cited by 8 publications

References 23 publications

Vaccines for preventing rotavirus diarrhoea: vaccines in use

Vaccines for preventing rotavirus diarrhoea: vaccines in use

Current status of rotavirus vaccines

Vaccines for preventing rotavirus diarrhoea: vaccines in use

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