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PneuMum: Impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia

Binks, Michael J., Moberley, Sarah A., Balloch, Anne, Leach, Amanda J., Nelson, Sandra, Hare, Kim M., Wilson, Cate, Morris, Peter S., Nelson, Jane N., Chatfield, Mark D., Tang, Mimi L.K., Torzillo, Paul J., Carapetis, Jonathan R., Mulholland, Edward K. and 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):6579-6587.

Document type: Journal Article
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IRMA ID 11381xPUB184
NHMRC Grant No. 350499
490320
Title PneuMum: Impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia
Author Binks, Michael J.
Moberley, Sarah A.
Balloch, Anne
Leach, Amanda J.
Nelson, Sandra
Hare, Kim M.
Wilson, Cate
Morris, Peter S.
Nelson, Jane N.
Chatfield, Mark D.
Tang, Mimi L.K.
Torzillo, Paul J.
Carapetis, Jonathan R.
Mulholland, Edward K.
Andrews, Ross M.
Journal Name Vaccine
Publication Date 2015
Volume Number 33
Issue Number 48
ISSN 0264-410X   (check CDU catalogue  open catalogue search in new window)
Scopus ID 2-s2.0-84949843753
Start Page 6579
End Page 6587
Total Pages 9
Place of Publication United Kingdom
Publisher Elsevier Ltd
HERDC Category C1 - Journal Article (DIISR)
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.
DOI http://dx.doi.org/10.1016/j.vaccine.2015.10.101   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)
Additional Notes This is an Open Access article distributed under the terms of the Creative Commons Attribution License 4.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Description for Link Link to CC Attribution 4.0 License
URL http://creativecommons.org/licenses/by-nc-nd/4.0/


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