Immunological Characteristics of a Population at Risk of Cholera After Oral Cholera Vaccine (CHOVAXIM)

NCT04423159 | Completed

• 1 other identifier: CHOVAXIM
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to find out if individuals who received first and second dose of Oral Cholera Vaccine (OCV) in Lukanga Swamps, Central Province of Zambia have developed protection against future attacks to cholera. The investigators also want to investigate whether vitamin A deficiency and being HIV positive increases the chances of suffering from cholera.

Conditions

Diarrhea Infectious

Keywords

Diarrhea; HIV; Vaccines

Outcome Measures

Primary Outcomes (1)

• Vibriocidal

  The primary aim of this project is to determine changes in the vibriocidal geometric mean titers at 6, 12, 24, 30, 36, 42 and 48 months (GMT) in participants who receive the second dose of oral cholera vaccine (OCV) at 28 days .

  4 years

Secondary Outcomes (2)

• Vibriocidal

  4 years

• Vibriocidal

  1 year

Study Arms (1)

OCV vaccine

EXPERIMENTAL

Shanchol 1.5mL to be administered orally. Each dose contains V.cholerae O1 Inaba El Tor Strain, Inaba classical strain, ogawa classical strain and O139 strain. As well as Thiomersal and a buffer

Biological: OCV Vaccine

Interventions

OCV Vaccine BIOLOGICAL

2 doses of OCV were administered to all enrolled participants 1st dose administered at baseline and second dose administered 28 days post 1st dose.

OCV vaccine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 18-65 years are eligible to participate.
• Participant is a resident of the study area. Residence was defined as individuals living in the study area for the past 1 year.
• Written consent provided by participant.

You may not qualify if:

• Participant aged less than 18 years
• Refuses to consent to participate
• Pregnancy
• Participant has acute medical illness prior to receipt of oral cholera vaccine -Participant has a history of hospitalization for cholera in the past one week

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead
• Johns Hopkins University: collaborator
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator

Study Sites (1)

Waya clinic

Kabwe, Central Province, 10101, Zambia

Location

MeSH Terms

Conditions

Dysentery; Diarrhea

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pre/post-vaccine study involving a cohort of individuals receiving an oral cholera vaccine in response to a cholera outbreak in the Lukanga Swamps.

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 9, 2020
• Study Start: October 16, 2016
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)