Safety of a bivalent, killed, whole-cell oral cholera vaccine in pregnant women in Bangladesh: evidence from a randomized placebo-controlled trial
Abstract Background Cholera 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. M...
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| Format: | Article |
| Language: | English |
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BMC
2019-05-01
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| Series: | BMC Infectious Diseases |
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| Online Access: | http://link.springer.com/article/10.1186/s12879-019-4006-3 |
| _version_ | 1818048019126288384 |
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| author | Ashraful Islam Khan Mohammad Ali Julia Lynch Alamgir Kabir Jean-Louis Excler Md. Arifuzzaman Khan Md. Taufiqul Islam Afroza Akter Fahima Chowdhury Amit Saha Iqbal Ansary Khan Sachin N. Desai Deok Ryun Kim Nirod Chandra Saha Ajit P. Singh John D. Clemens Firdausi Qadri |
| author_facet | Ashraful Islam Khan Mohammad Ali Julia Lynch Alamgir Kabir Jean-Louis Excler Md. Arifuzzaman Khan Md. Taufiqul Islam Afroza Akter Fahima Chowdhury Amit Saha Iqbal Ansary Khan Sachin N. Desai Deok Ryun Kim Nirod Chandra Saha Ajit P. Singh John D. Clemens Firdausi Qadri |
| author_sort | Ashraful Islam Khan |
| collection | DOAJ |
| description | Abstract Background Cholera 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. Methods Study 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. Result There 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. Conclusions Our 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 registration The study is registered at (http://clinicaltrials.gov). Identifier: NCT02027207. |
| first_indexed | 2024-12-10T10:15:01Z |
| format | Article |
| id | doaj.art-730d41469bf34b4290ae59b7c5c3ca1d |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-12-10T10:15:01Z |
| publishDate | 2019-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-730d41469bf34b4290ae59b7c5c3ca1d2022-12-22T01:53:01ZengBMCBMC Infectious Diseases1471-23342019-05-011911810.1186/s12879-019-4006-3Safety of a bivalent, killed, whole-cell oral cholera vaccine in pregnant women in Bangladesh: evidence from a randomized placebo-controlled trialAshraful Islam Khan0Mohammad Ali1Julia Lynch2Alamgir Kabir3Jean-Louis Excler4Md. Arifuzzaman Khan5Md. Taufiqul Islam6Afroza Akter7Fahima Chowdhury8Amit Saha9Iqbal Ansary Khan10Sachin N. Desai11Deok Ryun Kim12Nirod Chandra Saha13Ajit P. Singh14John D. Clemens15Firdausi Qadri16International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b)Johns Hopkins Bloomberg School of Public HealthInternational Vaccine InstituteInternational Centre for Diarrhoeal Disease Research Bangladesh (icddr,b)International Vaccine InstituteInternational Centre for Diarrhoeal Disease Research Bangladesh (icddr,b)International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b)International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b)International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b)International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b)International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b)International Vaccine InstituteInternational Vaccine InstituteInternational Centre for Diarrhoeal Disease Research Bangladesh (icddr,b)International Vaccine InstituteInternational Centre for Diarrhoeal Disease Research Bangladesh (icddr,b)International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b)Abstract Background Cholera 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. Methods Study 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. Result There 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. Conclusions Our 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 registration The study is registered at (http://clinicaltrials.gov). Identifier: NCT02027207.http://link.springer.com/article/10.1186/s12879-019-4006-3OCVCholeraPregnant womenSafetyBangladesh |
| spellingShingle | Ashraful Islam Khan Mohammad Ali Julia Lynch Alamgir Kabir Jean-Louis Excler Md. Arifuzzaman Khan Md. Taufiqul Islam Afroza Akter Fahima Chowdhury Amit Saha Iqbal Ansary Khan Sachin N. Desai Deok Ryun Kim Nirod Chandra Saha Ajit P. Singh John D. Clemens Firdausi Qadri 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 OCV Cholera Pregnant women Safety Bangladesh |
| title | Safety of a bivalent, killed, whole-cell oral cholera vaccine in pregnant women in Bangladesh: evidence from a randomized placebo-controlled trial |
| title_full | Safety of a bivalent, killed, whole-cell oral cholera vaccine in pregnant women in Bangladesh: evidence from a randomized placebo-controlled trial |
| title_fullStr | Safety of a bivalent, killed, whole-cell oral cholera vaccine in pregnant women in Bangladesh: evidence from a randomized placebo-controlled trial |
| title_full_unstemmed | Safety of a bivalent, killed, whole-cell oral cholera vaccine in pregnant women in Bangladesh: evidence from a randomized placebo-controlled trial |
| title_short | Safety of a bivalent, killed, whole-cell oral cholera vaccine in pregnant women in Bangladesh: evidence from a randomized placebo-controlled trial |
| title_sort | safety of a bivalent killed whole cell oral cholera vaccine in pregnant women in bangladesh evidence from a randomized placebo controlled trial |
| topic | OCV Cholera Pregnant women Safety Bangladesh |
| url | http://link.springer.com/article/10.1186/s12879-019-4006-3 |
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