Live attenuated tetravalent (G1-G4) bovine-human reassortant rotavirus vaccine (BRV-TV): Randomized, controlled phase III study in Indian infants

Saluja, Tarun; Palkar, Sonali; Misra, Puneet; Gupta, Madhu; Sriram, Damal Kandadai; Sood, Anil K.; Ravi, Mandyam Dhati; Shetty, Avinash K.; Dhaded, Sangappa; Agarkhedkar, Sharad; Choudhury, Amlan; Kumar, Ramesh; Balasubramanian, Sundaram; Babji, Sudhir; Adhikary, Lopa; Dupuy, Martin; Chadha, Sangeet Mohan; Desai, Forum; Kukian, D; Patnaik, Badri Narayan; Dhingra, Mandeep Singh

doi:10.1016/j.vaccine.2017.05.019

Cited by 13 publications

(14 citation statements)

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“…oral RV1 then other injected vaccines then oral sucrose, or to2. oral sucrose then other injected vaccines then oral RV1RV1 Zaman 2016Study investigated co‐administration of Measles‐rubella vaccines with RV vaccineRV5 / BRV‐TV Saluja 2017RCT of BRV‐TV versus RV5RV5 ACTRN12611000559910Ongoing observational studyRV5 Ciarlet 2008RCT of RV5 vaccine, but no placebo group reportedRV5 El Khoury 2011Mathematical model in BrazilRV5 El Khoury 2011aMathematical model in six Asian countriesRV5 Martinon‐Torres 2017RCT comparing standard versus alternative formulation of RV5RV5 McGrath 2014Not an RCTRV5 NCT00130832 2010Not RCT; open‐label study investigating different schedules of rotavirus and polio vaccine combinations without placeboRV5 NCT00496054Ongoing non‐randomized studyRV5 NCT01926015Staggered versus concomitant administration of DTP‐IPV with RV5RV5 Saleh 2018Standard versus alternative schedule RV5 (NCT01960725)RV5 Tugcu 2009RCT of RV5 vaccine, no placebo group reportedRV5 Uprety 2017Sub‐study of RV5 Levin 2017‐AF, this sub‐study only included participants in the vaccine arm and comparied HIV‐positive to HIV‐exposed but uninfected infants.RV5 Vesikari 2011RCT of RV5 and MenCC vaccines ‐ concomitant or sequential administration, no placebo group reportedRV5 Weinberg 2017Sub‐study of selected participants from RV5 Levin 2017‐AF, reporting only irrelevant outcomes for this review.…”

Section: Characteristics Of Excluded Studies [Ordered By Study Id]mentioning

confidence: 99%

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: Characteristics Of Excluded Studies [Ordered By Study Id]mentioning

confidence: 99%

Vaccines for preventing rotavirus diarrhoea: vaccines in use

Soares‐Weiser

Pitan

Cunliffe

2019

Cochrane Database of Systematic Reviews

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“…In Nigerien children, three doses had an efficacy of 67% against severe rotavirus gastroenteritis 36 . Yet another vaccine, this time a quadrivalent vaccine, produced by Shantha Biologicals of India using the same bovine backbone strain, did not meet immunogenicity non-inferiority compared to the pentavalent vaccine, as anti-rotavirus IgA seroconversion was only 47% compared to 61% 37 . A neonatal strain, RV3BB, developed by Australian researchers recently demonstrated a reasonable immune response in a rather small study; vaccine take occurred after three doses, regardless of whether the first dose was provided at 0–5 days or 8 weeks of life 38 .…”

Section: Rotavirus Vaccinesmentioning

confidence: 99%

Rotavirus Vaccines: a story of success with challenges ahead

O’Ryan

2017

F1000Res

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Approximately 40 years have passed since the discovery of the rotavirus and 10 years since the introduction and progressive dissemination of rotavirus vaccines worldwide. Currently, 92 countries have introduced rotavirus vaccines into national or subnational programs with evident impact in disease reduction. Two vaccines have been widely used, and four additional vaccines have been licensed and are being used in defined regions. In this context, one main issue that remains unsolved is the lower vaccine efficacy/effectiveness in low-income countries. An additional partially answered issue relates to rotavirus strain circulation in vaccinated populations. These issues are discussed in this review. The most imperative challenge ahead is to fulfill the WHO’s recommendation to introduce rotavirus vaccines in all countries.

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“… 56 Non-inferiority over HBRV non demonstrated. 57 No information available. A phase I study in Brazil showed good safety profile and evidence of immunogenicity in adults.…”

Section: Resultsmentioning

confidence: 99%

“… 56 A phase III clinical trial was conducted involving 1,200 Indian infants aged 6–8-weeks to show non-inferiority against a currently licensed vaccine based on immunogenicity, but the study failed to achieve its main endpoint. 57 The development of this vaccine is not being pursued any further. 25 …”

Section: Discussionmentioning

confidence: 99%

Established and new rotavirus vaccines: a comprehensive review for healthcare professionals

Vetter

Gardner

Debrus

et al. 2021

Human Vaccines & Immunotherapeutics

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Robust scientific evidence related to two rotavirus (RV) vaccines available worldwide demonstrates their significant impact on RV disease burden. Improving RV vaccination coverage may result in better RV disease control. To make RV vaccination accessible to all eligible children worldwide and improve vaccine effectiveness in high-mortality settings, research into new RV vaccines continues. Although current and in-development RV vaccines differ in vaccine design, their common goal is the reduction of RV disease risk in children <5 years old for whom disease burden is the most significant. Given the range of RV vaccines available, informed decision-making is essential regarding the choice of vaccine for immunization. This review aims to describe the landscape of current and new RV vaccines, providing context for the assessment of their similarities and differences. As data for new vaccines are limited, future investigations will be required to evaluate their performance/added value in a real-world setting.

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Live attenuated tetravalent (G1-G4) bovine-human reassortant rotavirus vaccine (BRV-TV): Randomized, controlled phase III study in Indian infants

Cited by 13 publications

References 19 publications

Vaccines for preventing rotavirus diarrhoea: vaccines in use

Vaccines for preventing rotavirus diarrhoea: vaccines in use

Rotavirus Vaccines: a story of success with challenges ahead

Established and new rotavirus vaccines: a comprehensive review for healthcare professionals

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