Immunogenicity of a Third Scheduled Dose of Rotarix in Australian Indigenous Infants: A Phase IV, Double-blind, Randomized, Placebo-Controlled Clinical Trial

Bianca F Middleton, Margie Danchin, Mark A Jones, Amanda J Leach, Nigel Cunliffe, Carl D Kirkwood, Jonathan Carapetis, Sarah Gallagher, Lea-Ann Kirkham, Caitlyn Granland, Monica McNeal, Julie A Marsh, Claire S Waddington, Thomas L Snelling

Research output: Contribution to journalArticlepeer-review

48 Downloads (Pure)

Abstract

BACKGROUND: Rotarix (GlaxoSmithKline) oral rotavirus vaccine is licensed as 2 doses in the first 6 months of life. In settings with high child mortality rates, clinical protection conferred by 2 doses of Rotarix is reduced. We assessed vaccine immune response when an additional dose of Rotarix was given to Australian Aboriginal children 6 to <12 months old. METHODS: ORVAC is a 2-stage, double-blind, randomized, placebo-controlled trial. Australian Aboriginal children 6 to <12 months old who had received 1 or 2 prior doses of Rotarix rotavirus vaccine were randomized 1:1 to receive an additional dose of Rotarix or matched placebo. The primary immunological end point was seroresponse defined as an anti-rotavirus immunoglobulin A level ≥20 AU/mL, 28-56 days after the additional dose of Rotarix or placebo. RESULTS: Between March 2018 and August 2020, a total of 253 infants were enrolled. Of these, 178 infants (70%) had analyzable serological results after follow-up; 89 were randomized to receive Rotarix, and 89 to receive placebo. The proportion with seroresponse was 85% after Rotarix compared with 72% after placebo. There were no occurrences of intussusception or any serious adverse events. CONCLUSIONS: An additional dose of Rotarix administered to Australian Aboriginal infants 6 to <12 months old increased the proportion with a vaccine seroresponse. CLINICAL TRIALS REGISTRATION: NCT02941107.

Original languageEnglish
Article numberjiac038
Pages (from-to)1537-1544
Number of pages8
JournalThe Journal of infectious diseases
Volume226
Issue number9
Early online date1 Feb 2022
DOIs
Publication statusPublished - 1 Nov 2022

Fingerprint

Dive into the research topics of 'Immunogenicity of a Third Scheduled Dose of Rotarix in Australian Indigenous Infants: A Phase IV, Double-blind, Randomized, Placebo-Controlled Clinical Trial'. Together they form a unique fingerprint.

Cite this