Follow-up of Pregnant Women After a Mass Vaccination of Oral Cholera Vaccine (ShancholTM) in Nsanje Malawi

NCT02499172 | Terminated Results

• 1 other identifier: 00006369
• Study Type: interventional
• Target: 2,758
• Locations: 1 country
• Sites: 1

Brief Summary

This study, to be carried out immediately following an emergency, reactive cholera vaccination campaign in Nsanje District, Malawi, will be a cohort study to estimate the safety of killed oral cholera vaccine (OCV), in pregnant women as measured by ShancholTM, on pregnancy outcomes and birth defects. While limited evidence which suggests that the vaccine is safe in pregnant women, this setting will allow investigators to answer this question in a community where more than 100,000 people will receive vaccine with no restrictions on pregnancy status. In past cholera vaccine campaigns including clinical trials, pregnant women were excluded due to lack of safety data. However, in this campaign, the decision by the Ministry of Health is that the benefits of offering vaccine to all individuals regardless of pregnancy status far outweigh any theoretical risk. Here the investigators specifically propose to: Specific Objective 1: To conduct surveillance of pregnant women to detect adverse pregnancy outcomes within communities in Nsanje District, Malawi that received oral cholera vaccine in a reactive vaccination campaign that started on 30 March 2015. Through household surveying and enrollment of pregnant women with monthly follow-up visits, the investigators will determine the cumulative incidence of adverse pregnancy outcomes among vaccinated and unvaccinated women in Nsanje and Chikwawa Districts, Malawi. Specific Objective 2: To compare the cumulative incidence of pregnancy loss (miscarriage and stillbirth) of women who received oral cholera vaccine while they were pregnant to women who were vaccinated and became pregnant after the end of the final round of vaccination in Nsanje and Chikwawa Districts, Malawi. Specific Objective 3: To compare the incidence of newborn malformations in a cohort of infants that had fetal exposure to oral cholera vaccine compared to those without such exposure in Nsanje and Chikwawa Districts, Malawi.

Conditions

Miscarriage; Stillbirth; Cholera

Keywords

Adverse pregnancy outcome

Outcome Measures

Primary Outcomes (1)

• Adverse Pregnancy Outcome

  The primary analysis will compare adverse pregnancy outcome (miscarriage and stillbirth) in Cohorts 1 and 3.

  Upto 42 weeks from the date of last menstrual period

Study Arms (4)

Cohort 1

EXPERIMENTAL

Cohort 1: Women who were pregnant and received at least one dose of ShancholTM during the mass OCV vaccination campaign.

Biological: Shanchol

Cohort 2

NO INTERVENTION

Cohort 2: Women who received at least one dose and who became pregnant after the mass vaccination campaign; hence their fetuses were not exposed to the vaccine.

Cohort 3

NO INTERVENTION

Cohort 3: Women who were pregnant in Chikwawa District at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.

Cohort 4

NO INTERVENTION

Cohort 4: Women who become pregnant in Chikwawa District after the vaccination campaign in Nsanje District, and who did not receive the vaccine during the campaign.

Interventions

Shanchol BIOLOGICAL

Cohort 1

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women aged 15-49 years old at time of consent (all cohorts)
• Urine sample provided if pregnancy test required (Not required if experienced delivery outcome between March 30 and enrollment date, OR visibly pregnant AND has due date indicated in Health Passport) (all cohorts)
• Received at least one dose of OCV in 2015 (must be verified with OCV Vaccination Card) (Cohorts 1 \& 2)
• Estimated last menstruation at least 3 weeks before the first dose of OCV received (Nsanje) or before March 30, 2015 (Chikwawa) (Cohorts 1 \& 3)
• Estimated last menstruation at least 2 weeks after the final dose of OCV received (Nsanje) or after the last day of OCV Round 2 (Chikwawa) (Cohorts 2 \& 4)
• Residing in Nsanje or Chikwawa Districts since the first day of the vaccination campaign (30 March 2015) (Cohorts 2 \& 3)
• Provides informed consent (with additional consent by the parent or legal guardian for unmarried \<18 years old) (All Cohorts)

You may not qualify if:

• Received at least one dose of OCV in 2015 (Cohorts 3 \& 4)
• An otherwise eligible pregnant women who is unable to be contacted after the second attempt within 48 hours after the first attempt to enroll (All cohorts)

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Ministry of Health, Malawi: collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Ali M, Nelson A, Luquero FJ, Azman AS, Debes AK, M'bang'ombe MM, Seyama L, Kachale E, Zuze K, Malichi D, Zulu F, Msyamboza KP, Kabuluzi S, Sack DA. Safety of a killed oral cholera vaccine (Shanchol) in pregnant women in Malawi: an observational cohort study. Lancet Infect Dis. 2017 May;17(5):538-544. doi: 10.1016/S1473-3099(16)30523-0. Epub 2017 Feb 2.

  PMID: 28161570 DERIVED

MeSH Terms

Conditions

Abortion, Spontaneous; Stillbirth; Cholera

Interventions

shanchol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

All the participants could not be followed up due to financial reason

Results Point of Contact

• Title: Dr. Mohammad Ali
• Organization: Johns Hopkins Bloomberg School of Public Health

mali25@jhu.edu

410-502-3154

Study Officials

• Mohammad Ali, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 16, 2015
• Study Start: June 1, 2015
• Primary Completion: October 30, 2016
• Study Completion: October 30, 2016
• Last Updated: January 3, 2024
• Results First Posted: April 16, 2019

Record last verified: 2024-01

Locations

US (1)