Safety of the oral cholera vaccine in pregnancy: Retrospective findings from a subgroup following mass vaccination campaign in Dhaka, Bangladesh

• DOI: 10.1016/j.vaccine.2017.01.080
• Publication Date: 2017-02-11T13:00:48Z
• Authors: Ashraful Islam Khan; Mohammad Ali; Fahima Chowdhury; Amit Saha; Iqbal Ansary Khan; Arifuzzaman Khan; Afroza Akter; Muhammad Asaduzzaman; Md. Taufiqul Islam; Alamgir Kabir; Young Ae You; Nirod Chandra Saha; Alejandro Cravioto; John D. Clemens; Firdausi Qadri
• Keywords: Cholera vaccine

Pregnant women are vulnerable to complications of cholera. Killed oral cholera vaccines (OCV) not recommended for pregnant though there is no evidence harmful effects during pregnancy. We evaluated the effect a killed OCV, Shanchol™, on pregnancy outcomes an effectiveness trial vaccine in urban Bangladesh.Individuals ⩾1year were invited participate trial, conducted 2011 Dhaka, Bangladesh. Pregnancy by history was exclusion criterion and all reproductive age (15-49years) verbally questioned about at enrollment prior vaccination. Out 48,414 286 received OCV unknowingly while pregnant. these, we could recruit 69 defined as exposed OCV. Accordingly, selected randomly from those who did take (non-exposed OCV). adverse outcome (spontaneous miscarriages, still births, or congenital malformations) between OCV.About 16% had loss, compared 12% unvaccinated (P=0.38). One anomaly observed occurred non-exposed group. Models that adjusted baseline characteristics unbalanced groups, revealed elevation risk vaccinees versus non-vaccinees (Adj. OR (95% CI): 0.45 (0.11-1.88).No excess fetal associated with receipt this study.Clinical Trials.gov number NCT01339845.