Safety and immunogenicity of RV3-BB human neonatal rotavirus vaccine administered at birth or in infancy: a randomised, double-blind, placebo-controlled trial

Bines, Julie E; Danchin, Margaret; Jackson, P. C.; Handley, Amanda; Watts, Emma; Lee, Katherine J.; West, Amanda; Cowley, Daniel; Chen, Mee-Yew; Barnes, Graeme L.; Justice, Frances; Buttery, Jim; Carlin, John B.; Bishop, Ruth F.; Taylor, B. J.; Kirkwood, Carl D.

doi:10.1016/s1473-3099(15)00227-3

Cited by 72 publications

(88 citation statements)

References 35 publications

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“…Phase II safety and immunogenicity trials in New Zealand demonstrated high levels of vaccine take in a developed setting following the administration of 3 doses commencing either in the first week of life or at 6-12 weeks of age. 48 Vaccine take was demonstrated in 90% of neonatal participants, and 93% of infant participants. 48 Larger trials in Indonesia are examining immunogenicity and efficacy in a developing setting.…”

Section: Development Of New Rotavirus Vaccine Candidatesmentioning

confidence: 99%

“…48 Vaccine take was demonstrated in 90% of neonatal participants, and 93% of infant participants. 48 Larger trials in Indonesia are examining immunogenicity and efficacy in a developing setting.…”

Section: Development Of New Rotavirus Vaccine Candidatesmentioning

confidence: 99%

“…2 Early rotavirus vaccine administration close to birth is an attractive potential strategy, and has been trialled in New Zealand, Indonesia and Ghana, with initial results suggesting similar vaccine take to that achieved by infant dosing. 7,48 The major potential benefit of vaccines administered at birth is that immune protection may be conferred prior to the early onset of rotavirus infection and the associated risk of severe disease in infants in developing regions, without an increased risk of intussusception. 48 However, the immaturity of the neonatal immune system may hinder a full response to vaccines administered at this time.…”

Section: Changes To Rotavirus Immunisation Schedulesmentioning

confidence: 99%

“…7,48 The major potential benefit of vaccines administered at birth is that immune protection may be conferred prior to the early onset of rotavirus infection and the associated risk of severe disease in infants in developing regions, without an increased risk of intussusception. 48 However, the immaturity of the neonatal immune system may hinder a full response to vaccines administered at this time. In addition, neonatal dosing regimens are more likely to be successfully delivered to target infants in low-income regions where the timeliness and coverage of EPI vaccinations decreases with each successive scheduled timepoint.…”

Section: Changes To Rotavirus Immunisation Schedulesmentioning

confidence: 99%

“…In addition, neonatal dosing regimens are more likely to be successfully delivered to target infants in low-income regions where the timeliness and coverage of EPI vaccinations decreases with each successive scheduled timepoint. 17,48,73,74 Increasing the number of rotavirus vaccine doses Waning vaccine efficacy from one year post-immunisation may be addressed through the administration of additional vaccine doses. 75 Lopman et al proposed that extra vaccine doses later in the EPI schedule may target the severe symptomatic nature of higher-order infections in low-income countries, estimating a 9% improvement in RV1 vaccine efficacy with a 3-dose course at 6, 10 and 14 weeks.…”

Section: Changes To Rotavirus Immunisation Schedulesmentioning

confidence: 99%

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Options for improving effectiveness of rotavirus vaccines in developing countries

Tissera

Cowley

Bogdanovic-Sakran

et al. 2017

Human Vaccines & Immunotherapeutics

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Rotavirus gastroenteritis is a leading global cause of mortality and morbidity in young children due to diarrhea and dehydration. Over 85% of deaths occur in developing countries. In industrialised countries, 2 live oral rotavirus vaccines licensed in 2006 quickly demonstrated high effectiveness, dramatically reducing severe rotavirus gastroenteritis admissions in many settings by more than 90%. In contrast, the same vaccines reduced severe rotavirus gastroenteritis by only 30-60% in developing countries, but have been proven life-saving. Bridging this "efficacy gap" offers the possibility to save many more lives of children under the age of 5. The reduced efficacy of rotavirus vaccines in developing settings may be related to differences in transmission dynamics, as well as host luminal, mucosal and immune factors. This review will examine strategies currently under study to target the issue of reduced efficacy and effectiveness of oral rotavirus vaccines in developing settings.

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Section: Development Of New Rotavirus Vaccine Candidatesmentioning

confidence: 99%

Section: Development Of New Rotavirus Vaccine Candidatesmentioning

confidence: 99%

Section: Changes To Rotavirus Immunisation Schedulesmentioning

confidence: 99%

Section: Changes To Rotavirus Immunisation Schedulesmentioning

confidence: 99%

Section: Changes To Rotavirus Immunisation Schedulesmentioning

confidence: 99%

See 3 more Smart Citations

Options for improving effectiveness of rotavirus vaccines in developing countries

Tissera

Cowley

Bogdanovic-Sakran

et al. 2017

Human Vaccines & Immunotherapeutics

Self Cite

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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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