Journal article
Molecular characterisation of rotavirus strains detected during a clinical trial of the human neonatal rotavirus vaccine (RV3-BB) in Indonesia
D Cowley, H Nirwati, CM Donato, N Bogdanovic-Sakran, K Boniface, CD Kirkwood, JE Bines
Vaccine | ELSEVIER SCI LTD | Published : 2018
Abstract
Background: The RV3-BB human neonatal rotavirus vaccine aims to provide protection from severe rotavirus disease from birth. The aim of the current study was to characterise the rotavirus strains causing gastroenteritis during the Indonesian Phase IIb efficacy trial. Methods: A randomized, double-blind placebo-controlled trial involving 1649 participants was conducted from January 2013 to July 2016 in Central Java and Yogyakarta, Indonesia. Participants received three doses of oral RV3-BB vaccine with the first dose given at 0–5 days after birth (neonatal schedule), or the first dose given at ∼8 weeks after birth (infant schedule), or placebo (placebo schedule). Stool samples from episodes o..
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Awarded by Bill and Melinda Gates Foundation
Funding Acknowledgements
This trial was funded by the Australian National Health and Medical Research Council, the Bill and Melinda Gates Foundation, PT BioFarma. C.D.K was supported by an NHMRC CDA fellowship (607347). This research at Murdoch Children's Research Institute was supported by the Victorian Government's Operational Infrastructure Support Program. The Faculty of Medicine Universitas Gadjah Mada (H.N.W) received funds as part of a clinical trial agreement with Murdoch Children's Research Institute and PT BioFarma. C.M.D is supported through the Australian National Health and Medical Research Council with an Early Career Fellowship (1113269).