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

Immunogenicity to Cholera Vaccine Within a Population at Risk in Zambia: Mapping the Kinetics of Immune Responses Over Time

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.

Study Overview

• Status: Completed
• Conditions: Diarrhea Infectious
• Intervention / Treatment: Biological: OCV Vaccine

Detailed Description

Cholera is caused by toxigenic strains of Vibrio cholerae O1 and O139 and is characterised by sudden onset of acute watery diarrhoea that can lead to severe dehydration and ultimately death if not treated. Zambia, has continued to experience cholera outbreaks in several parts of the country. In order to curb the disease outbreaks, the World Health Organisation (WHO) recommended introducing cholera vaccination as a supplementary cholera control measure together with other prevention and control strategies, in endemic areas as well as in other places at risk for cholera outbreaks. OCV has recently been introduced to Zambia where a large population was vaccinated with 1 dose of Shanchol®, and about 6 months later over 70% individuals traced to receive a second dose.

Considering the annual outbreaks of cholera in Zambia, there is urgent need to determine whether Shanchol® is able to elicit a sufficient and specific immunological response in individuals who received OCV in Zambia. This study will also help the investigator understand whether there are immune response differences based on genetics and may indicate whether some people may need more vaccine regimens than others.

Objective 1: To profile cholera specific antibody status of a population at risk of cholera before and after receiving 1st and 2nd dose of shanchol ® oral cholera vaccine (OCV) Objective 2: To profile and characterize cholera specific B and T lymphocyte phenotypes among the immunized Zambians Objective 3: Develop and evaluate a non-invasive proxy measure of OCV immune responses Objective 4: To measure the protective value of immunizing HIV-infected individuals through measurement of the neutralization capabilities OCV generated antibodies Objective 5: To assess the impact of ABO blood groups on cholera antibody generation

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Central
    • Kabwe, Central, Zambia, 10101
      • Waya clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OCV vaccine; 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; 2 doses of OCV were administered to all enrolled participants 1st dose administered at baseline and second dose administered 28 days post 1st dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vibriocidal	Vibriocidal Antibody Response Rates in HIV infected individuals	4 years
Vibriocidal	Detection of vibriocidal antibodies in saliva and compare to serum at 1 year post OCV vaccination	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2016
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Diarrhea; HIV; Vaccines
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vibrio Infections; Diarrhea; Cholera; Dysentery
• Other Study ID Numbers: CHOVAXIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No