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

Diarrhea Infectious Clinical Trial

— CHOVAXIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04423159
• Other study ID #: CHOVAXIM
• Status: Completed
• Phase: N/A
• Start date: October 16, 2016
• Est. completion date: October 31, 2020

Study information

• Verified date: July 2022
• Source: Centre for Infectious Disease Research in Zambia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholera
• Diarrhea
• Diarrhea Infectious
• Dysentery

Intervention

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.

Locations

Country	Name	City	State
Zambia	Waya clinic	Kabwe	Central

Sponsors (3)

Lead Sponsor	Collaborator
Centre for Infectious Disease Research in Zambia	European and Developing Countries Clinical Trials Partnership (EDCTP), Johns Hopkins University

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vibriocidal	Vibriocidal Antibody Response Rates in HIV infected individuals	4 years
Secondary	Vibriocidal	Detection of vibriocidal antibodies in saliva and compare to serum at 1 year post OCV vaccination	1 year