Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study

Lise Grout, Isabel Martinez-Pino, Iza Ciglenecki, Sakoba Keita, Alpha Amadou Diallo, Balla Traore, Daloka Delamou, Oumar Toure, Sarala Nicholas, Barbara Rusch, Nelly Staderini, Micaela Serafini, Rebecca F. Grais, Francisco J. Luquero

Research output: Contribution to journalArticle

Abstract

Introduction: Since 2010, WHO has recommended oral cholera vaccines as an additional strategy for cholera control. During a cholera episode, pregnant women are at high risk of complications, and the risk of fetal death has been reported to be 2–36%. Due to a lack of safety data, pregnant women have been excluded from most cholera vaccination campaigns. In 2012, reactive campaigns using the bivalent killed whole-cell oral cholera vaccine (BivWC), included all people living in the targeted areas aged ≥1 year regardless of pregnancy status, were implemented in Guinea. We aimed to determine whether there was a difference in pregnancy outcomes between vaccinated and non-vaccinated pregnant women. Methods and Findings: From 11 November to 4 December 2013, we conducted a retrospective cohort study in Boffa prefecture among women who were pregnant in 2012 during or after the vaccination campaign. The primary outcome was pregnancy loss, as reported by the mother, and fetal malformations, after clinical examination. Primary exposure was the intake of the BivWC vaccine (Shanchol) during pregnancy, as determined by a vaccination card or oral history. We compared the risk of pregnancy loss between vaccinated and non-vaccinated women through binomial regression analysis. A total of 2,494 pregnancies were included in the analysis. The crude incidence of pregnancy loss was 3.7% (95%CI 2.7–4.8) for fetuses exposed to BivWC vaccine and 2.6% (0.7–4.5) for non-exposed fetuses. The incidence of malformation was 0.6% (0.1–1.0) and 1.2% (0.0–2.5) in BivWC-exposed and non-exposed fetuses, respectively. In both crude and adjusted analyses, fetal exposure to BivWC was not significantly associated with pregnancy loss (adjusted risk ratio (aRR = 1.09 [95%CI: 0.5–2.25], p = 0.818) or malformations (aRR = 0.50 [95%CI: 0.13–1.91], p = 0.314). Conclusions: In this large retrospective cohort study, we found no association between fetal exposure to BivWC and risk of pregnancy loss or malformation. Despite the weaknesses of a retrospective design, we can conclude that if a risk exists, it is very low. Additional prospective studies are warranted to add to the evidence base on OCV use during pregnancy. Pregnant women are particularly vulnerable during cholera episodes and should be included in vaccination campaigns when the risk of cholera is high, such as during outbreaks.

Original languageEnglish (US)
Article numbere0004274
JournalPLoS Neglected Tropical Diseases
Volume9
Issue number12
DOIs
StatePublished - Dec 29 2015

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Cholera Vaccines
Guinea
Mass Vaccination
Immunization Programs
Pregnancy Outcome
Cohort Studies
Retrospective Studies
Cholera
Pregnancy
Pregnant Women
Fetus
Vaccines
Fetal Death
Incidence
Disease Outbreaks
Vaccination
Odds Ratio
Regression Analysis
Mothers
Prospective Studies

ASJC Scopus subject areas

  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Grout, L., Martinez-Pino, I., Ciglenecki, I., Keita, S., Diallo, A. A., Traore, B., ... Luquero, F. J. (2015). Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study. PLoS Neglected Tropical Diseases, 9(12), [e0004274]. https://doi.org/10.1371/journal.pntd.0004274

Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea : A Retrospective Cohort Study. / Grout, Lise; Martinez-Pino, Isabel; Ciglenecki, Iza; Keita, Sakoba; Diallo, Alpha Amadou; Traore, Balla; Delamou, Daloka; Toure, Oumar; Nicholas, Sarala; Rusch, Barbara; Staderini, Nelly; Serafini, Micaela; Grais, Rebecca F.; Luquero, Francisco J.

In: PLoS Neglected Tropical Diseases, Vol. 9, No. 12, e0004274, 29.12.2015.

Research output: Contribution to journalArticle

Grout, L, Martinez-Pino, I, Ciglenecki, I, Keita, S, Diallo, AA, Traore, B, Delamou, D, Toure, O, Nicholas, S, Rusch, B, Staderini, N, Serafini, M, Grais, RF & Luquero, FJ 2015, 'Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study', PLoS Neglected Tropical Diseases, vol. 9, no. 12, e0004274. https://doi.org/10.1371/journal.pntd.0004274
Grout, Lise ; Martinez-Pino, Isabel ; Ciglenecki, Iza ; Keita, Sakoba ; Diallo, Alpha Amadou ; Traore, Balla ; Delamou, Daloka ; Toure, Oumar ; Nicholas, Sarala ; Rusch, Barbara ; Staderini, Nelly ; Serafini, Micaela ; Grais, Rebecca F. ; Luquero, Francisco J. / Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea : A Retrospective Cohort Study. In: PLoS Neglected Tropical Diseases. 2015 ; Vol. 9, No. 12.
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title = "Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study",
abstract = "Introduction: Since 2010, WHO has recommended oral cholera vaccines as an additional strategy for cholera control. During a cholera episode, pregnant women are at high risk of complications, and the risk of fetal death has been reported to be 2–36{\%}. Due to a lack of safety data, pregnant women have been excluded from most cholera vaccination campaigns. In 2012, reactive campaigns using the bivalent killed whole-cell oral cholera vaccine (BivWC), included all people living in the targeted areas aged ≥1 year regardless of pregnancy status, were implemented in Guinea. We aimed to determine whether there was a difference in pregnancy outcomes between vaccinated and non-vaccinated pregnant women. Methods and Findings: From 11 November to 4 December 2013, we conducted a retrospective cohort study in Boffa prefecture among women who were pregnant in 2012 during or after the vaccination campaign. The primary outcome was pregnancy loss, as reported by the mother, and fetal malformations, after clinical examination. Primary exposure was the intake of the BivWC vaccine (Shanchol) during pregnancy, as determined by a vaccination card or oral history. We compared the risk of pregnancy loss between vaccinated and non-vaccinated women through binomial regression analysis. A total of 2,494 pregnancies were included in the analysis. The crude incidence of pregnancy loss was 3.7{\%} (95{\%}CI 2.7–4.8) for fetuses exposed to BivWC vaccine and 2.6{\%} (0.7–4.5) for non-exposed fetuses. The incidence of malformation was 0.6{\%} (0.1–1.0) and 1.2{\%} (0.0–2.5) in BivWC-exposed and non-exposed fetuses, respectively. In both crude and adjusted analyses, fetal exposure to BivWC was not significantly associated with pregnancy loss (adjusted risk ratio (aRR = 1.09 [95{\%}CI: 0.5–2.25], p = 0.818) or malformations (aRR = 0.50 [95{\%}CI: 0.13–1.91], p = 0.314). Conclusions: In this large retrospective cohort study, we found no association between fetal exposure to BivWC and risk of pregnancy loss or malformation. Despite the weaknesses of a retrospective design, we can conclude that if a risk exists, it is very low. Additional prospective studies are warranted to add to the evidence base on OCV use during pregnancy. Pregnant women are particularly vulnerable during cholera episodes and should be included in vaccination campaigns when the risk of cholera is high, such as during outbreaks.",
author = "Lise Grout and Isabel Martinez-Pino and Iza Ciglenecki and Sakoba Keita and Diallo, {Alpha Amadou} and Balla Traore and Daloka Delamou and Oumar Toure and Sarala Nicholas and Barbara Rusch and Nelly Staderini and Micaela Serafini and Grais, {Rebecca F.} and Luquero, {Francisco J.}",
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T1 - Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea

T2 - A Retrospective Cohort Study

AU - Grout, Lise

AU - Martinez-Pino, Isabel

AU - Ciglenecki, Iza

AU - Keita, Sakoba

AU - Diallo, Alpha Amadou

AU - Traore, Balla

AU - Delamou, Daloka

AU - Toure, Oumar

AU - Nicholas, Sarala

AU - Rusch, Barbara

AU - Staderini, Nelly

AU - Serafini, Micaela

AU - Grais, Rebecca F.

AU - Luquero, Francisco J.

PY - 2015/12/29

Y1 - 2015/12/29

N2 - Introduction: Since 2010, WHO has recommended oral cholera vaccines as an additional strategy for cholera control. During a cholera episode, pregnant women are at high risk of complications, and the risk of fetal death has been reported to be 2–36%. Due to a lack of safety data, pregnant women have been excluded from most cholera vaccination campaigns. In 2012, reactive campaigns using the bivalent killed whole-cell oral cholera vaccine (BivWC), included all people living in the targeted areas aged ≥1 year regardless of pregnancy status, were implemented in Guinea. We aimed to determine whether there was a difference in pregnancy outcomes between vaccinated and non-vaccinated pregnant women. Methods and Findings: From 11 November to 4 December 2013, we conducted a retrospective cohort study in Boffa prefecture among women who were pregnant in 2012 during or after the vaccination campaign. The primary outcome was pregnancy loss, as reported by the mother, and fetal malformations, after clinical examination. Primary exposure was the intake of the BivWC vaccine (Shanchol) during pregnancy, as determined by a vaccination card or oral history. We compared the risk of pregnancy loss between vaccinated and non-vaccinated women through binomial regression analysis. A total of 2,494 pregnancies were included in the analysis. The crude incidence of pregnancy loss was 3.7% (95%CI 2.7–4.8) for fetuses exposed to BivWC vaccine and 2.6% (0.7–4.5) for non-exposed fetuses. The incidence of malformation was 0.6% (0.1–1.0) and 1.2% (0.0–2.5) in BivWC-exposed and non-exposed fetuses, respectively. In both crude and adjusted analyses, fetal exposure to BivWC was not significantly associated with pregnancy loss (adjusted risk ratio (aRR = 1.09 [95%CI: 0.5–2.25], p = 0.818) or malformations (aRR = 0.50 [95%CI: 0.13–1.91], p = 0.314). Conclusions: In this large retrospective cohort study, we found no association between fetal exposure to BivWC and risk of pregnancy loss or malformation. Despite the weaknesses of a retrospective design, we can conclude that if a risk exists, it is very low. Additional prospective studies are warranted to add to the evidence base on OCV use during pregnancy. Pregnant women are particularly vulnerable during cholera episodes and should be included in vaccination campaigns when the risk of cholera is high, such as during outbreaks.

AB - Introduction: Since 2010, WHO has recommended oral cholera vaccines as an additional strategy for cholera control. During a cholera episode, pregnant women are at high risk of complications, and the risk of fetal death has been reported to be 2–36%. Due to a lack of safety data, pregnant women have been excluded from most cholera vaccination campaigns. In 2012, reactive campaigns using the bivalent killed whole-cell oral cholera vaccine (BivWC), included all people living in the targeted areas aged ≥1 year regardless of pregnancy status, were implemented in Guinea. We aimed to determine whether there was a difference in pregnancy outcomes between vaccinated and non-vaccinated pregnant women. Methods and Findings: From 11 November to 4 December 2013, we conducted a retrospective cohort study in Boffa prefecture among women who were pregnant in 2012 during or after the vaccination campaign. The primary outcome was pregnancy loss, as reported by the mother, and fetal malformations, after clinical examination. Primary exposure was the intake of the BivWC vaccine (Shanchol) during pregnancy, as determined by a vaccination card or oral history. We compared the risk of pregnancy loss between vaccinated and non-vaccinated women through binomial regression analysis. A total of 2,494 pregnancies were included in the analysis. The crude incidence of pregnancy loss was 3.7% (95%CI 2.7–4.8) for fetuses exposed to BivWC vaccine and 2.6% (0.7–4.5) for non-exposed fetuses. The incidence of malformation was 0.6% (0.1–1.0) and 1.2% (0.0–2.5) in BivWC-exposed and non-exposed fetuses, respectively. In both crude and adjusted analyses, fetal exposure to BivWC was not significantly associated with pregnancy loss (adjusted risk ratio (aRR = 1.09 [95%CI: 0.5–2.25], p = 0.818) or malformations (aRR = 0.50 [95%CI: 0.13–1.91], p = 0.314). Conclusions: In this large retrospective cohort study, we found no association between fetal exposure to BivWC and risk of pregnancy loss or malformation. Despite the weaknesses of a retrospective design, we can conclude that if a risk exists, it is very low. Additional prospective studies are warranted to add to the evidence base on OCV use during pregnancy. Pregnant women are particularly vulnerable during cholera episodes and should be included in vaccination campaigns when the risk of cholera is high, such as during outbreaks.

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