Safety of a bivalent, killed, whole-cell oral cholera vaccine in pregnant women in Bangladesh: evidence from a randomized placebo-controlled trial

BMC Infectious Diseases

Ajit P. Singh¹  Jean-Louis Excler¹  Julia Lynch¹  Sachin N. Desai¹  Deok Ryun Kim¹  Mohammad Ali²  John D. Clemens³  Fahima Chowdhury³  Md. Taufiqul Islam³  Afroza Akter³  Nirod Chandra Saha³  Md. Arifuzzaman Khan³  Ashraful Islam Khan³  Amit Saha³  Firdausi Qadri³  Iqbal Ansary Khan³  Alamgir Kabir³ 

[1] 0000 0000 9629 885X, grid.30311.30, International Vaccine Institute, Seoul, South Korea;0000 0001 2171 9311, grid.21107.35, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA;0000 0004 0600 7174, grid.414142.6, International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), 68, Shaheed Tajuddin Ahmed Sarani, 1212, Mohakhali Dhaka, Bangladesh;

关键词: OCV;    Cholera;    Pregnant women;    Safety;    Bangladesh;   

DOI  :  10.1186/s12879-019-4006-3

来源: publisher

【 摘 要 】

BackgroundCholera increases the risk of harmful effects on foetuses. We prospectively followed pregnant women unaware of their pregnancy status who received a study agent in a clinical trial evaluating the association between exposure to an oral cholera vaccine (OCV) and foetal survival.MethodsStudy participants were selected from a randomized placebo-controlled trial conducted in Dhaka, Bangladesh. The vaccination campaign was conducted between January 10 and February 4, 2014. We enrolled women who were exposed to an OCV or placebo during pregnancy (Cohort 1) and women who were pregnant after the vaccination was completed (Cohort 2). Our primary endpoint was pregnancy loss (spontaneous miscarriage or stillbirth), and the secondary endpoints were preterm delivery and low birth weight. We employed a log-binomial regression to calculate the relative risk of having adverse outcomes among OCV recipients compared to that among placebo recipients.ResultThere were 231 OCV and 234 placebo recipients in Cohort 1 and 277 OCV and 299 placebo recipients in Cohort 2. In Cohort 1, the incidence of pregnancy loss was 113/1000 and 115/1000 among OCV and placebo recipients, respectively. The adjusted relative risk for pregnancy loss was 0.97 (95% CI: 0.58–1.61; p = 0.91) in Cohort 1. We did not observe any variation in the risk of pregnancy loss between the two cohorts. The risks for preterm delivery and low birth weight were not significantly different between the groups in both cohorts.ConclusionsOur study provides additional evidence that exposure to an OCV during pregnancy does not increase the risk of pregnancy loss, preterm delivery, or low birth weight, suggesting that pregnant women in cholera-affected regions should not be excluded in a mass vaccination campaign.Trial registrationThe study is registered at (http://clinicaltrials.gov). Identifier: NCT02027207.

【 授权许可】

CC BY