Middleton, Bianca F, Danchin, Margie, Jones, Mark A, Leach, Amanda J, Cunliffe, Nigel 
ORCID: 0000-0002-5449-4988, Kirkwood, Carl D, Carapetis, Jonathan, Gallagher, Sarah, Kirkham, Lea-Ann, Granland, Caitlyn et al (show 4 more authors)
(2022)
Immunogenicity of a Third Scheduled Dose of Rotarix in Australian Indigenous Infants: A Phase IV, Double-blind, Randomized, Placebo-Controlled Clinical Trial.
JOURNAL OF INFECTIOUS DISEASES, 226 (9).
pp. 1537-1544.
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Abstract
<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>An additional dose of Rotarix administered to Australian Aboriginal infants 6 to <12 months old increased the proportion with a vaccine seroresponse.<h4>Clinical trials registration</h4>NCT02941107.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Aboriginal, clinical trial, Immunogenicity, Rotarix, rotavirus vaccine |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Infection, Veterinary and Ecological Sciences |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 20 Jan 2023 11:54 |
| Last Modified: | 20 Jan 2023 11:56 |
| DOI: | 10.1093/infdis/jiac038 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3167749 |
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