Binks, Michael J; Moberley, Sarah A; Balloch, Anne; Leach, Amanda J; Nelson, Sandra; Hare, Kim M; Wilson, Cate; Morris, Peter S; Nelson, Jane; Chatfield, Mark D; +5 more... Tang, Mimi LK; Torzillo, Paul; Carapetis, Jonathan R; Mulholland, E Kim; Andrews, Ross M; (2015) PneuMum: Impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia. Vaccine, 33 (48). pp. 6579-6587. ISSN 0264-410X DOI: https://doi.org/10.1016/j.vaccine.2015.10.101
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Abstract
BACKGROUND: We assessed maternal 23-valent pneumococcal polysaccharide (23vPPV) vaccine efficacy (VE) against middle ear disease and pneumococcal carriage amongst Australian Indigenous infants. METHODS: In an open label, allocation concealed, outcome-assessor blinded, community stratified, randomised controlled trial, healthy pregnant Indigenous women aged 17-39 years in the Northern Territory of Australia received the 23vPPV (1:1:1) at: 30-36 weeks gestation, birth, or were unvaccinated (ClinicalTrials.gov NCT00714064). Co-primary outcomes were the point prevalences of infant middle ear disease and 23vPPV-type carriage at age 7 months. RESULTS: The consent rate was 50% (313/632). Among 227 eligible participants randomised, retention rates were 86% (66/77) controls; 89% (67/75) pregnancy vaccinees; 88% (66/75) birth vaccinees. At infant age 7 months, ear disease prevalence was: 71% (47/66) controls, 63% (42/67) pregnancy vaccinees, 76% (50/66) birth vaccinees; and 23vPPV-type carriage was: 26% (17/66) controls, 18% (12/67) pregnancy vaccinees, 18% (12/66) birth vaccinees. For pregnancy vaccinees, VE was 12% (95% CI -12% to 31%) against infant ear disease and 30% (95% CI -34% to 64%) against 23vPPV-type carriage. In a post-hoc analysis, VE against infant ear disease concurrent with carriage of 23vPPV or related types was 51% (95% CI -2% to 76%). There were no serious adverse effects following receipt of the 23vPPV in pregnancy or at birth. CONCLUSIONS: In a high risk population, our study was unable to demonstrate efficacy of 23vPPV in pregnancy against the co-primary outcomes of either all-cause infant ear disease or 23vPPV-type nasopharyngeal carriage at age 7 months. Efficacy against ear disease concurrent with carriage of vaccine-related serotypes (a more specific outcome) suggests 23vPPV in pregnancy may complement childhood pneumococcal vaccination programs.
Item Type | Article |
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Faculty and Department | Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology & International Health (2023-) |
Research Centre |
Centre for Maternal, Reproductive and Child Health (MARCH) Vaccine Centre |
PubMed ID | 26529076 |
ISI | 366791200016 |
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Licence: Creative Commons: Attribution-Noncommercial-No Derivative Works 3.0
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