TY - JOUR
T1 - Safety of the oral cholera vaccine in pregnancy
T2 - Retrospective findings from a subgroup following mass vaccination campaign in Dhaka, Bangladesh
AU - Khan, Ashraful Islam
AU - Ali, Mohammad
AU - Chowdhury, Fahima
AU - Saha, Amit
AU - Khan, Iqbal Ansary
AU - Khan, Arifuzzaman
AU - Akter, Afroza
AU - Asaduzzaman, Muhammad
AU - Islam, Md Taufiqul
AU - Kabir, Alamgir
AU - You, Young Ae
AU - Saha, Nirod Chandra
AU - Cravioto, Alejandro
AU - Clemens, John D.
AU - Qadri, Firdausi
N1 - Funding Information:
This study was supported by a Grant OPP50419 from the Bill & Melinda Gates Foundation Additionally the study was also supported by core grants to the icddr,b. icddr,b also gratefully acknowledges the following donors who provide unrestricted support: Government of the People's Republic of Bangladesh; Global Affairs Canada (GAC); Swedish International Development Cooperation Agency (Sida) and the Department for International Development, (UKAid). Shantha-Sanofi provided vaccine for the study at a discretionary price. We are grateful to the people of Mirpur where our study is being undertaken; to the field, laboratory and data management staff who provided tremendous effort to make the study successful; and to the people who provided valuable support in our study.
Publisher Copyright:
© 2017
PY - 2017/3/13
Y1 - 2017/3/13
N2 - 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 evaluated the effect of a killed OCV, Shanchol™, on pregnancy outcomes during an effectiveness trial of the vaccine in urban Bangladesh. Methodology Individuals ⩾1 year were invited to participate in the trial, conducted in 2011 in Dhaka, Bangladesh. Pregnancy by history was an exclusion criterion and all women of reproductive age (15–49 years) were verbally questioned about pregnancy at enrollment and prior to vaccination. Out of 48,414 women of reproductive age 286 women received the OCV unknowingly while pregnant. Out of these, we could recruit 69 women defined as exposed to OCV. Accordingly, we selected 69 pregnant women randomly from those who did not take the OCV (non-exposed to OCV). We evaluated adverse pregnancy outcome (spontaneous miscarriages, still births, or congenital malformations) between those who were exposed to OCV and those who were not exposed to OCV. Results About 16% of pregnant women exposed to OCV had pregnancy loss, as compared to 12% of unvaccinated pregnant women (P = 0.38). One congenital anomaly was observed and occurred in women non-exposed to OCV group. Models that adjusted for baseline characteristics that were unbalanced between the exposed and non-exposed groups, revealed a no elevation of risk of adverse pregnancy outcomes in vaccinees versus non-vaccinees (Adj. OR (95% CI): 0.45 (0.11–1.88). Conclusions No excess of adverse fetal outcomes associated with receipt of OCV was observed in this study. Trial registration: Clinical Trials.gov number NCT01339845.
AB - 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 evaluated the effect of a killed OCV, Shanchol™, on pregnancy outcomes during an effectiveness trial of the vaccine in urban Bangladesh. Methodology Individuals ⩾1 year were invited to participate in the trial, conducted in 2011 in Dhaka, Bangladesh. Pregnancy by history was an exclusion criterion and all women of reproductive age (15–49 years) were verbally questioned about pregnancy at enrollment and prior to vaccination. Out of 48,414 women of reproductive age 286 women received the OCV unknowingly while pregnant. Out of these, we could recruit 69 women defined as exposed to OCV. Accordingly, we selected 69 pregnant women randomly from those who did not take the OCV (non-exposed to OCV). We evaluated adverse pregnancy outcome (spontaneous miscarriages, still births, or congenital malformations) between those who were exposed to OCV and those who were not exposed to OCV. Results About 16% of pregnant women exposed to OCV had pregnancy loss, as compared to 12% of unvaccinated pregnant women (P = 0.38). One congenital anomaly was observed and occurred in women non-exposed to OCV group. Models that adjusted for baseline characteristics that were unbalanced between the exposed and non-exposed groups, revealed a no elevation of risk of adverse pregnancy outcomes in vaccinees versus non-vaccinees (Adj. OR (95% CI): 0.45 (0.11–1.88). Conclusions No excess of adverse fetal outcomes associated with receipt of OCV was observed in this study. Trial registration: Clinical Trials.gov number NCT01339845.
KW - Oral cholera vaccine
KW - Pregnancy
KW - Shanchol™
KW - Vaccination
UR - http://www.scopus.com/inward/record.url?scp=85012012648&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85012012648&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2017.01.080
DO - 10.1016/j.vaccine.2017.01.080
M3 - Article
C2 - 28196715
AN - SCOPUS:85012012648
SN - 0264-410X
VL - 35
SP - 1538
EP - 1543
JO - Vaccine
JF - Vaccine
IS - 11
ER -