PneuMum

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

Michael J. Binks, Sarah A. Moberley, Anne Balloch, Amanda J. Leach, Sandra Nelson, Kim M. Hare, Catherine Wilson, Peter S. Morris, Jane Nelson, Mark D. Chatfield, Mimi L K Tang, Paul Torzillo, Jonathan R. Carapetis, Edward Kim Mulholland, Ross M. Andrews

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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.

Original languageEnglish
Pages (from-to)6579-6587
Number of pages9
JournalVaccine
Volume33
Issue number48
DOIs
Publication statusPublished - 27 Nov 2015

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ear diseases
Northern Territory
Ear Diseases
Middle Ear
Polysaccharides
Vaccination
polysaccharides
Randomized Controlled Trials
vaccination
Mothers
pregnancy
Pregnancy
Parturition
vaccines
Vaccines
Pneumococcal Vaccines
disease prevalence
childhood
Pregnant Women
complement

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Binks, Michael J. ; Moberley, Sarah A. ; Balloch, Anne ; Leach, Amanda J. ; Nelson, Sandra ; Hare, Kim M. ; Wilson, Catherine ; Morris, Peter S. ; Nelson, Jane ; Chatfield, Mark D. ; Tang, Mimi L K ; Torzillo, Paul ; Carapetis, Jonathan R. ; Mulholland, Edward Kim ; Andrews, Ross M. / PneuMum : Impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia. In: Vaccine. 2015 ; Vol. 33, No. 48. pp. 6579-6587.
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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",
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.",
keywords = "Pneumococcus vaccine, adolescent, adult, Article, comparative study, controlled study, drug efficacy, drug safety, female, high risk population, human, Indigenous Australian, infant, infant disease, male, maternal vaccination, middle ear disease, normal human, open study, outcome assessment, prevalence, priority journal, randomized controlled trial, seasonal influenza, serotype, unspecified side effect, vaccination",
author = "Binks, {Michael J.} and Moberley, {Sarah A.} and Anne Balloch and Leach, {Amanda J.} and Sandra Nelson and Hare, {Kim M.} and Catherine Wilson and Morris, {Peter S.} and Jane Nelson and Chatfield, {Mark D.} and Tang, {Mimi L K} and Paul Torzillo and Carapetis, {Jonathan R.} and Mulholland, {Edward Kim} and Andrews, {Ross M.}",
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language = "English",
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Binks, MJ, Moberley, SA, Balloch, A, Leach, AJ, Nelson, S, Hare, KM, Wilson, C, Morris, PS, Nelson, J, Chatfield, MD, Tang, MLK, Torzillo, P, Carapetis, JR, Mulholland, EK & Andrews, RM 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, vol. 33, no. 48, pp. 6579-6587. https://doi.org/10.1016/j.vaccine.2015.10.101

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, Catherine; Morris, Peter S.; Nelson, Jane; Chatfield, Mark D.; Tang, Mimi L K; Torzillo, Paul; Carapetis, Jonathan R.; Mulholland, Edward Kim; Andrews, Ross M.

In: Vaccine, Vol. 33, No. 48, 27.11.2015, p. 6579-6587.

Research output: Contribution to journalArticleResearchpeer-review

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T2 - Impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia

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AU - Moberley, Sarah A.

AU - Balloch, Anne

AU - Leach, Amanda J.

AU - Nelson, Sandra

AU - Hare, Kim M.

AU - Wilson, Catherine

AU - Morris, Peter S.

AU - Nelson, Jane

AU - Chatfield, Mark D.

AU - Tang, Mimi L K

AU - Torzillo, Paul

AU - Carapetis, Jonathan R.

AU - Mulholland, Edward Kim

AU - Andrews, Ross M.

N1 - NHMRC Grant No. 350499 and 490320

PY - 2015/11/27

Y1 - 2015/11/27

N2 - 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.

AB - 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.

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