Human Neonatal Rotavirus Vaccine (RV3-BB) to Target Rotavirus from Birth

The New England Journal of Medicine
Julie E BinesYati Soenarto

Abstract

A strategy of administering a neonatal rotavirus vaccine at birth to target early prevention of rotavirus gastroenteritis may address some of the barriers to global implementation of a rotavirus vaccine. We conducted a randomized, double-blind, placebo-controlled trial in Indonesia to evaluate the efficacy of an oral human neonatal rotavirus vaccine (RV3-BB) in preventing rotavirus gastroenteritis. Healthy newborns received three doses of RV3-BB, administered according to a neonatal schedule (0 to 5 days, 8 weeks, and 14 weeks of age) or an infant schedule (8 weeks, 14 weeks, and 18 weeks of age), or placebo. The primary analysis was conducted in the per-protocol population, which included only participants who received all four doses of vaccine or placebo within the visit windows, with secondary analyses performed in the intention-to-treat population, which included all participants who underwent randomization. Among the 1513 participants in the per-protocol population, severe rotavirus gastroenteritis occurred up to the age of 18 months in 5.6% of the participants in the placebo group (28 of 504 babies), in 1.4% in the neonatal-schedule vaccine group (7 of 498), and in 2.7% in the infant-schedule vaccine group (14 of 511). Th...Continue Reading

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Citations

Feb 9, 2019·Human Vaccines & Immunotherapeutics·A D SteeleC D Kirkwood
Jan 29, 2019·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Mateusz Hasso-AgopsowiczUNKNOWN Global Rotavirus Surveillance Network, Rotavirus Age Study Collaborators
Mar 27, 2019·The Cochrane Database of Systematic Reviews·Karla Soares-WeiserNigel Cunliffe
Aug 6, 2019·PloS One·Jarir At ThobariJim P Buttery
Oct 3, 2019·Acta Paediatrica·Maria Grazia ClementePietro Vajro
Jan 28, 2020·The Journal of Infectious Diseases·Benjamin A Lopman, Julia M Baker
Jul 16, 2019·Current Opinion in Infectious Diseases·Rachel M BurkeUmesh D Parashar
Nov 7, 2019·The Cochrane Database of Systematic Reviews·Karla Soares-WeiserNigel Cunliffe
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Sep 10, 2020·Virusdisease·Yan Song, Wei Liu
Jul 2, 2020·Vaccines·Olufemi Samuel Folorunso, Olihile M Sebolai
Jan 14, 2021·Virus Research·Yuta Kanai, Takeshi Kobayashi
Nov 17, 2020·Journal of Paediatrics and Child Health·Edward V O'Loughlin, Donald J S Cameron
Feb 20, 2021·Human Vaccines & Immunotherapeutics·Volker VetterPriya Pereira
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Nov 18, 2021·The Cochrane Database of Systematic Reviews·Hanna BergmanKarla Soares-Weiser
Aug 11, 2021·The Journal of Infectious Diseases·Rachel M BurkeUmesh D Parashar

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