Curtin University Homepage
  • Library
  • FAQ
    • Log in

    espace - Curtin’s institutional repository

    JavaScript is disabled for your browser. Some features of this site may not work without it.
    View Item 
    • espace Home
    • espace
    • Curtin Research Publications
    • View Item
    • espace Home
    • espace
    • Curtin Research Publications
    • View Item

    Safety of a killed oral cholera vaccine (Shanchol) in pregnant women in Malawi: an observational cohort study

    Access Status
    Open access via publisher
    Authors
    Ali, Mohammed
    Nelson, A.
    Luquero, F.
    Azman, A.
    Debes, A.
    M'bang'ombe, M.
    Seyama, L.
    Kachale, E.
    Zuze, K.
    Malichi, D.
    Zulu, F.
    Msyamboza, K.
    Kabuluzi, S.
    Sack, D.
    Date
    2017
    Collection
    • Curtin Research Publications
    Type
    Journal Article
    Metadata
    Show full item record
    Abstract

    © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license Background Pregnancy increases the risk of harmful effects from cholera for both mothers and their fetuses. A killed oral cholera vaccine, Shanchol (Shantha Biotechnics, Hydrabad, India), can protect against the disease for up to 5 years. However, cholera vaccination campaigns have often excluded pregnant women because of insufficient safety data for use during pregnancy. We did an observational cohort study to assess the safety of Shanchol during pregnancy. Methods This observational cohort study was done in two adjacent districts (Nsanje and Chikwawa) in Malawi. Individuals older than 1 year in Nsanje were offered oral cholera vaccine during a mass vaccination campaign between March 30 and April 30, 2015, but no vaccines were administered in Chikwawa. We enrolled women who were exposed to oral cholera vaccine during pregnancy in Nsanje district, and women who were pregnant in Chikwawa district (and thus not exposed to oral cholera vaccine) during the same period. The primary endpoint of our analysis was pregnancy loss (spontaneous miscarriage or stillbirth), and the secondary endpoints were neonatal deaths and malformations. We evaluated these endpoints using log-binomial regression, adjusting for the imbalanced baseline characteristics between the groups. This study is registered with ClinicalTrials.gov, number NCT02499172. Findings We recruited 900 women exposed to oral cholera vaccine and 899 women not exposed to the vaccine between June 16 and Oct 10, 2015, and analysed 835 in each group. 361 women exposed to the vaccine and 327 not exposed to the vaccine were recruited after their pregnancies had ended. The incidence of pregnancy loss was 27·54 (95% CI 18·41–41·23) per 1000 pregnancies among those exposed to the vaccine and 21·56 (13·65–34·04) per 1000 among those not exposed. The adjusted relative risk for pregnancy loss among those exposed to oral cholera vaccine was 1·24 (95% CI 0·64–2·43; p=0·52) compared with those not exposed to the vaccine. The neonatal mortality rate was 11·78 (95% CI 5·92–23·46) per 1000 livebirths for infants whose mothers were exposed to oral cholera vaccine versus 8·91 (4·02–19·77) per 1000 livebirths for infants whose mothers were not exposed to the vaccine (crude relative risk 1·32, 95% CI 0·46–3·84; p=0·60). Only three newborn babies had malformations, two in the vaccine exposure group and one in the no-exposure group, yielding a relative risk of 2·00 (95% CI 0·18–22·04; p=0·57), although this estimate is unreliable because of the small number of outcomes. Interpretation Our study provides evidence that fetal exposure to oral cholera vaccine confers no significantly increased risk of pregnancy loss, neonatal mortality, or malformation. These data, along with findings from two retrospective studies, support use of oral cholera vaccine in pregnant women in cholera-affected regions. Funding Bill & Melinda Gates Foundation.

    Citation
    Ali, M. and Nelson, A. and Luquero, F. and Azman, A. and Debes, A. and M'bang'ombe, M. and Seyama, L. et al. 2017. Safety of a killed oral cholera vaccine (Shanchol) in pregnant women in Malawi: an observational cohort study. The Lancet Infectious Diseases. 17 (5): pp. 538-544.
    Source Title
    The Lancet Infectious Diseases
    URI
    http://hdl.handle.net/20.500.11937/65928
    DOI
    10.1016/S1473-3099(16)30523-0
    Department
    School of Nursing, Midwifery and Paramedicine

    Related items

    Showing items related by title, author, creator and subject.

    • Safety of the oral cholera vaccine in pregnancy: Retrospective findings from a subgroup following mass vaccination campaign in Dhaka, Bangladesh
      Khan, A.; Ali, Mohammed; Chowdhury, F.; Saha, A.; Khan, I.; Khan, A.; Akter, A.; Asaduzzaman, M.; Islam, M.; Kabir, A.; You, Y.; Saha, N.; Cravioto, A.; Clemens, J.; Qadri, F. (2017)
      © 2017 Background Pregnant women are vulnerable to complications of cholera. Killed oral cholera vaccines (OCV) are not recommended for pregnant women though there is no evidence of harmful effects during pregnancy. We ...
    • Safety of the recombinant cholera toxin B subunit, killed whole-cell (rBS-WC) Oral Cholera vaccine in pregnancy
      Hashim, R.; Khatib, A.; Enwere, G.; Park, J.; Reyburn, R.; Ali, Mohammed; Chang, N.; Kim, D.; Ley, B.; Thriemer, K.; Lopez, A.; Clemens, J.; Deen, J.; Shin, S.; Schaetti, C.; Hutubessy, R.; Aguado, M.; Kieny, M.; Sack, D.; Obaro, S.; Shaame, A.; Ali, S.; Saleh, A.; von Seidlein, L.; Jiddawi, M. (2012)
      Introduction: Mass vaccinations are a main strategy in the deployment of oral cholera vaccines. Campaigns avoid giving vaccine to pregnant women because of the absence of safety data of the killed whole-cell oral cholera ...
    • Potential for Controlling Cholera Using a Ring Vaccination Strategy: Re-analysis of Data from a Cluster-Randomized Clinical Trial
      Ali, Mohammed; Debes, A.; Luquero, F.; Kim, D.; Park, J.; Digilio, L.; Manna, B.; Kanungo, S.; Dutta, S.; Sur, D.; Bhattacharya, S.; Sack, D. (2016)
      © 2016 Ali et al. Introduction: Vaccinating a buffer of individuals around a case (ring vaccination) has the potential to target those who are at highest risk of infection, reducing the number of doses needed to control ...
    Advanced search

    Browse

    Communities & CollectionsIssue DateAuthorsTitlesSubjectsDocument TypesThis CollectionIssue DateAuthorsTitlesSubjectsDocument Types

    My Account

    Log in

    Statistics

    Most Popular ItemsStatistics by CountryMost Popular Authors

    Connect with Curtin

    • 
    • 
    • 
    • 
    • 
    • 
    • 

    CRICOS Provider Code: 00301JABN: 99 143 842 569TEQSA: PRV12158

    Send FeedbackContact Us
    DSpace software copyright © 2002-2015  DuraSpace