Birth outcomes in Aboriginal mother–infant pairs from the Northern Territory, Australia, who received 23-valent polysaccharide pneumococcal vaccination during pregnancy, 2006–2011

The PneuMum randomised controlled trial

Lisa McHugh, Michael Binks, Robert S. Ware, Tom Snelling, Sandra Nelson, Jane Nelson, Melissa Dunbar, E. Kim Mulholland, Ross M. Andrews

    Research output: Contribution to journalArticleResearchpeer-review

    Abstract

    Background: Pregnant women and infants <6 months old have a high baseline risk for pneumococcal disease compared to the general population, particularly among Indigenous populations living in poverty and low-resource settings. Efficacy trials of pneumococcal vaccination in pregnancy examining adverse birth outcomes are lacking.

    Aims: We report adverse birth events as secondary outcomes from the ‘PneuMum’ randomised controlled trial of 23-valent pneumococcal polysaccharide vaccination (23vPPV) in pregnancy (August 2006–January 2011).

    Materials and methods: Australian Aboriginal women aged 17–39 years with singleton uncomplicated pregnancies were randomised (1:2 ratio) to receive 23vPPV or no 23vPPV in pregnancy at 30–36 weeks gestation. We compared risks of stillbirth, preterm birth, low birthweight (LBW), and small for gestational age (SGA) between vaccinated and unvaccinated pregnant women. Cox proportional hazard ratios (HRs) were calculated on an intention-to-treat basis.

    Results: Among 227 enrolled participants, 75 (33%) received 23vPPV in pregnancy. Risk differences in adverse birth outcomes between 23vPPV vaccinated and unvaccinated pregnant women were; preterm birth 9% vs 4% (HR 2.79; 95% CI 0.94–8.32) P = 0.07; LBW 9% vs 5% (HR 2.09; 95% CI 0.76–5.78) P = 0.15; and SGA 15% vs 17% (HR 1.02; 95% CI 0.50–2.06) P = 0.96. There were no stillbirths.

    Conclusions: We found a numerically higher rate of preterm births among women who received 23vPPV in pregnancy compared to unvaccinated pregnant women. Although further investigation with larger participant numbers is needed to better evaluate this safety signal, the contribution of safety results from smaller studies using appropriate data analysis methodologies is critical, particularly as more clinical trials in pneumococcal vaccination in pregnancy are progressing.

    Original languageEnglish
    Pages (from-to)1-6
    Number of pages6
    JournalAustralian and New Zealand Journal of Obstetrics and Gynaecology
    DOIs
    Publication statusE-pub ahead of print - 14 Jun 2019

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    Northern Territory
    Polysaccharides
    Vaccination
    Randomized Controlled Trials
    Parturition
    Pregnancy
    Pregnant Women
    Premature Birth
    Stillbirth
    Gestational Age
    Safety
    Poverty
    Population Groups
    Clinical Trials

    Cite this

    @article{567d0a0c3b7d45e7996de5f8402c29c7,
    title = "Birth outcomes in Aboriginal mother–infant pairs from the Northern Territory, Australia, who received 23-valent polysaccharide pneumococcal vaccination during pregnancy, 2006–2011: The PneuMum randomised controlled trial",
    abstract = "Background: Pregnant women and infants <6 months old have a high baseline risk for pneumococcal disease compared to the general population, particularly among Indigenous populations living in poverty and low-resource settings. Efficacy trials of pneumococcal vaccination in pregnancy examining adverse birth outcomes are lacking. Aims: We report adverse birth events as secondary outcomes from the ‘PneuMum’ randomised controlled trial of 23-valent pneumococcal polysaccharide vaccination (23vPPV) in pregnancy (August 2006–January 2011). Materials and methods: Australian Aboriginal women aged 17–39 years with singleton uncomplicated pregnancies were randomised (1:2 ratio) to receive 23vPPV or no 23vPPV in pregnancy at 30–36 weeks gestation. We compared risks of stillbirth, preterm birth, low birthweight (LBW), and small for gestational age (SGA) between vaccinated and unvaccinated pregnant women. Cox proportional hazard ratios (HRs) were calculated on an intention-to-treat basis. Results: Among 227 enrolled participants, 75 (33{\%}) received 23vPPV in pregnancy. Risk differences in adverse birth outcomes between 23vPPV vaccinated and unvaccinated pregnant women were; preterm birth 9{\%} vs 4{\%} (HR 2.79; 95{\%} CI 0.94–8.32) P = 0.07; LBW 9{\%} vs 5{\%} (HR 2.09; 95{\%} CI 0.76–5.78) P = 0.15; and SGA 15{\%} vs 17{\%} (HR 1.02; 95{\%} CI 0.50–2.06) P = 0.96. There were no stillbirths. Conclusions: We found a numerically higher rate of preterm births among women who received 23vPPV in pregnancy compared to unvaccinated pregnant women. Although further investigation with larger participant numbers is needed to better evaluate this safety signal, the contribution of safety results from smaller studies using appropriate data analysis methodologies is critical, particularly as more clinical trials in pneumococcal vaccination in pregnancy are progressing.",
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    author = "Lisa McHugh and Michael Binks and Ware, {Robert S.} and Tom Snelling and Sandra Nelson and Jane Nelson and Melissa Dunbar and Mulholland, {E. Kim} and Andrews, {Ross M.}",
    year = "2019",
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    Birth outcomes in Aboriginal mother–infant pairs from the Northern Territory, Australia, who received 23-valent polysaccharide pneumococcal vaccination during pregnancy, 2006–2011 : The PneuMum randomised controlled trial. / McHugh, Lisa; Binks, Michael; Ware, Robert S.; Snelling, Tom; Nelson, Sandra; Nelson, Jane; Dunbar, Melissa; Mulholland, E. Kim; Andrews, Ross M.

    In: Australian and New Zealand Journal of Obstetrics and Gynaecology, 14.06.2019, p. 1-6.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - Birth outcomes in Aboriginal mother–infant pairs from the Northern Territory, Australia, who received 23-valent polysaccharide pneumococcal vaccination during pregnancy, 2006–2011

    T2 - The PneuMum randomised controlled trial

    AU - McHugh, Lisa

    AU - Binks, Michael

    AU - Ware, Robert S.

    AU - Snelling, Tom

    AU - Nelson, Sandra

    AU - Nelson, Jane

    AU - Dunbar, Melissa

    AU - Mulholland, E. Kim

    AU - Andrews, Ross M.

    PY - 2019/6/14

    Y1 - 2019/6/14

    N2 - Background: Pregnant women and infants <6 months old have a high baseline risk for pneumococcal disease compared to the general population, particularly among Indigenous populations living in poverty and low-resource settings. Efficacy trials of pneumococcal vaccination in pregnancy examining adverse birth outcomes are lacking. Aims: We report adverse birth events as secondary outcomes from the ‘PneuMum’ randomised controlled trial of 23-valent pneumococcal polysaccharide vaccination (23vPPV) in pregnancy (August 2006–January 2011). Materials and methods: Australian Aboriginal women aged 17–39 years with singleton uncomplicated pregnancies were randomised (1:2 ratio) to receive 23vPPV or no 23vPPV in pregnancy at 30–36 weeks gestation. We compared risks of stillbirth, preterm birth, low birthweight (LBW), and small for gestational age (SGA) between vaccinated and unvaccinated pregnant women. Cox proportional hazard ratios (HRs) were calculated on an intention-to-treat basis. Results: Among 227 enrolled participants, 75 (33%) received 23vPPV in pregnancy. Risk differences in adverse birth outcomes between 23vPPV vaccinated and unvaccinated pregnant women were; preterm birth 9% vs 4% (HR 2.79; 95% CI 0.94–8.32) P = 0.07; LBW 9% vs 5% (HR 2.09; 95% CI 0.76–5.78) P = 0.15; and SGA 15% vs 17% (HR 1.02; 95% CI 0.50–2.06) P = 0.96. There were no stillbirths. Conclusions: We found a numerically higher rate of preterm births among women who received 23vPPV in pregnancy compared to unvaccinated pregnant women. Although further investigation with larger participant numbers is needed to better evaluate this safety signal, the contribution of safety results from smaller studies using appropriate data analysis methodologies is critical, particularly as more clinical trials in pneumococcal vaccination in pregnancy are progressing.

    AB - Background: Pregnant women and infants <6 months old have a high baseline risk for pneumococcal disease compared to the general population, particularly among Indigenous populations living in poverty and low-resource settings. Efficacy trials of pneumococcal vaccination in pregnancy examining adverse birth outcomes are lacking. Aims: We report adverse birth events as secondary outcomes from the ‘PneuMum’ randomised controlled trial of 23-valent pneumococcal polysaccharide vaccination (23vPPV) in pregnancy (August 2006–January 2011). Materials and methods: Australian Aboriginal women aged 17–39 years with singleton uncomplicated pregnancies were randomised (1:2 ratio) to receive 23vPPV or no 23vPPV in pregnancy at 30–36 weeks gestation. We compared risks of stillbirth, preterm birth, low birthweight (LBW), and small for gestational age (SGA) between vaccinated and unvaccinated pregnant women. Cox proportional hazard ratios (HRs) were calculated on an intention-to-treat basis. Results: Among 227 enrolled participants, 75 (33%) received 23vPPV in pregnancy. Risk differences in adverse birth outcomes between 23vPPV vaccinated and unvaccinated pregnant women were; preterm birth 9% vs 4% (HR 2.79; 95% CI 0.94–8.32) P = 0.07; LBW 9% vs 5% (HR 2.09; 95% CI 0.76–5.78) P = 0.15; and SGA 15% vs 17% (HR 1.02; 95% CI 0.50–2.06) P = 0.96. There were no stillbirths. Conclusions: We found a numerically higher rate of preterm births among women who received 23vPPV in pregnancy compared to unvaccinated pregnant women. Although further investigation with larger participant numbers is needed to better evaluate this safety signal, the contribution of safety results from smaller studies using appropriate data analysis methodologies is critical, particularly as more clinical trials in pneumococcal vaccination in pregnancy are progressing.

    KW - Aboriginal

    KW - pneumococcal

    KW - pregnancy

    KW - safety

    KW - vaccination

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    U2 - 10.1111/ajo.13002

    DO - 10.1111/ajo.13002

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    JO - Australian and New Zealand Journal of Obstetrics and Gynaecology

    JF - Australian and New Zealand Journal of Obstetrics and Gynaecology

    SN - 0004-8666

    ER -