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

The Lancet Infectious Diseases
J E BinesRV3 Rotavirus Vaccine Program

Abstract

Despite the success of rotavirus vaccines, suboptimal vaccine efficacy in regions with a high burden of disease continues to present a challenge to worldwide implementation. A birth dose strategy with a vaccine developed from an asymptomatic neonatal rotavirus strain has the potential to address this challenge and provide protection from severe rotavirus disease from birth. This phase 2a randomised, double-blind, three-arm, placebo-controlled safety and immunogenicity trial was undertaken at a single centre in New Zealand between Jan 13, 2012, and April 17, 2014. Healthy, full-term (≥36 weeks gestation) babies, who weighed at least 2500 g, and were 0-5 days old at the time of randomisation were randomly assigned (1:1:1; computer-generated; telephone central allocation) according to a concealed block randomisation schedule to oral RV3-BB vaccine with the first dose given at 0-5 days after birth (neonatal schedule), to vaccine with the first dose given at about 8 weeks after birth (infant schedule), or to placebo. The primary endpoint was cumulative vaccine take (serum immune response or stool shedding of vaccine virus after any dose) after three doses. The immunogenicity analysis included all randomised participants with availab...Continue Reading

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Citations

Jan 30, 2016·The Journal of Infectious Diseases·Nigel Cunliffe, Gagandeep Kang
Sep 1, 2015·The Lancet Infectious Diseases·Timo Vesikari
Nov 12, 2016·Human Vaccines & Immunotherapeutics·Marion S TisseraJim P Buttery
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May 10, 2017·Human Vaccines & Immunotherapeutics·Daniel CowleyJulie E Bines
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Feb 2, 2018·Paediatric Drugs·Eleanor BurnettJacqueline Tate
Mar 27, 2019·The Cochrane Database of Systematic Reviews·Karla Soares-WeiserNigel Cunliffe
Nov 15, 2017·Human Vaccines & Immunotherapeutics·Jacqueline DeenRebecca F Grais
Nov 26, 2019·The Journal of Infectious Diseases·Karen BonifaceJulie E Bines
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Feb 20, 2021·Human Vaccines & Immunotherapeutics·Volker VetterPriya Pereira
Nov 18, 2021·The Cochrane Database of Systematic Reviews·Hanna BergmanKarla Soares-Weiser

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