Safety and immunogenicity of two live attenuated human rotavirus vaccine candidates, 116E and I321, in infants: Results of a randomised controlled trial

Bhandari, Nita; Sharma, Pooja; Glass, Roger I.; Ray, Pratima; Greenberg, Harry B.; Taneja, Sunita; Saksena, Manju; Rao, D. Narayana; Gentsch, Jon R.; Parashar, Umesh D.; Maldonado, Yvonne; Ward, Richard L.; Bhan, Maharaj Kishan

doi:10.1016/j.vaccine.2006.05.001

Cited by 68 publications

(53 citation statements)

References 15 publications

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“…A recent randomized double blinded placebo controlled trial for this stain has demonstrated that the vaccine elicits a strong immune response in Indian children [11]. This study, as well as previous studies, did not find any association with vaccination and adverse events [10,11]. Phase 3 trials of the 116E vaccine in India are in progress.…”

Section: Candidate Rotavirus Vaccines In Indiasupporting

confidence: 48%

“…After 37 generations, the LLR vaccine has proved to consist of monovalent serotype of (P [12]G [10]), group A [5]. This RV vaccine was licensed formally for gastroenteritis prevention (group A rotavirus) among children in China in 2000.…”

Section: Llrmentioning

confidence: 99%

“…One candidate is based on a neonatal rotavirus strain, 116E, and is being developed by Bharat Biotech International Limited. This strain is a natural reassortant between a human rotavirus virus G9P [11] strain with the VP4 protein from a bovine rotavirus strain and was originally isolated from a neonate with an asymptomatic rotavirus infection [10]. A recent randomized double blinded placebo controlled trial for this stain has demonstrated that the vaccine elicits a strong immune response in Indian children [11].…”

Section: Candidate Rotavirus Vaccines In Indiamentioning

confidence: 99%

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Rotavirus Infection: A Perspective on Epidemiology, Genomic Diversity and Vaccine Strategies

Mukherjee

Chawla‐Sarkar

2011

Indian J. Virol.

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Section: Candidate Rotavirus Vaccines In Indiasupporting

confidence: 48%

Section: Llrmentioning

confidence: 99%

Section: Candidate Rotavirus Vaccines In Indiamentioning

confidence: 99%

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Rotavirus Infection: A Perspective on Epidemiology, Genomic Diversity and Vaccine Strategies

Mukherjee

Chawla‐Sarkar

2011

Indian J. Virol.

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“…In a phase I trial it appeared highly immunogenic after a single dose. 141 Meanwhile, early trials with RV3 showed limited replication in the gut, but after three doses at 3, 5 and 7 months of age the following year it provided some protection in the 46% of subjects who developed an immune response. 142 Increasing vaccine titre to improve the immunogenicity of RV3 is allowing phase II trials to be planned for New Zealand and Indonesia.…”

Section: Other Candidate Vaccinesmentioning

confidence: 99%

“…143 Vaccines derived from naturally occurring neonatal strains that provide subsequent protection against symptomatic infections could prove most useful in this context. 141,142 However, RRV-TV has also been studied in neonates where it appeared to be less immunogenic in this age group compared with infants who were first immunized at 2 months of age. 139 Whether reduced immunogenicity translates into lowered efficacy is unknown, but the possibility of blocking maternal transplacental antibodies will need to be considered when testing vaccines in the newborn period.…”

Section: Challengesmentioning

confidence: 99%

Rotavirus vaccines: Opportunities and challenges

Grimwood¹,

Lambert²

2009

Human Vaccines

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Vaccines for preventing rotavirus diarrhoea: vaccines in use

Soares‐Weiser

Bergman

Henschke

et al. 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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Safety and immunogenicity of two live attenuated human rotavirus vaccine candidates, 116E and I321, in infants: Results of a randomised controlled trial

Cited by 68 publications

References 15 publications

Rotavirus Infection: A Perspective on Epidemiology, Genomic Diversity and Vaccine Strategies

Rotavirus Infection: A Perspective on Epidemiology, Genomic Diversity and Vaccine Strategies

Rotavirus vaccines: Opportunities and challenges

Vaccines for preventing rotavirus diarrhoea: vaccines in use

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