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

    Cite this

    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.
    @article{f122695e289e43e798bb59536b954322,
    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.}",
    note = "NHMRC Grant No. 350499 and 490320",
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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

    AU - Binks, Michael J.

    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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