Correlates of Protection for Cholera

Cholera Clinical Trial

— CoP  

Official title:

Correlates of Protection for Cholera

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455852
• Other study ID #: PR-24048
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: September 30, 2029

Study information

• Verified date: June 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Vibrio cholerae causes millions of cholera cases and thousands of deaths annually. Vaccines are in short supply. There is no agreement on how to introduce new vaccines or evaluate their effectiveness, and the lack of 'correlates of protection' (CoPs) against cholera is a major obstacle to vaccine development. CoPs are markers of effective immune response to vaccination. While other infectious diseases have well established CoPs, none are widely accepted for cholera.

Relevance: Lack of accepted CoPs impedes development of cholera vaccines, limiting progress toward improved vaccines, slowing the licensure of new vaccines, and contributing to the current vaccine shortage; an immediate obstacle to achieving reductions in cholera-related illness and deaths. The identification of new CoPs will speed the development of improved cholera vaccines and provide a pathway to their licensure and use.

Hypothesis: We hypothesize that some individuals who receive inactivated oral cholera vaccine (OCV) will develop antibody responses which predict protection against V. cholerae infection and that specific immune responses distinguish individuals who are protected against cholera by prior natural infection from those who are protected from OCVs.

Objectives: We will administer an OCV or typhoid vaccine (TCV) control and monitor antibody responses to identify better CoPs for cholera following both vaccination and natural infection.

Methods: We will randomize 1219 individuals; 554 will receive an inactivated bivalent OCV, 665 will receive a TCV control. We will collect 12 blood samples over two-years following vaccination to measure antibodies against V. cholerae and to monitor for re-infection.

Outcome measures/variables: The endpoint of interest is V. cholerae infection after vaccination. We define infection as positive culture or PCR for V. cholerae or seroconversion events observed over the 2-year follow up period.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1219
• Est. completion date: September 30, 2029
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

Inclusion criteria

1. Ages 2 - 80 years.

2. Informed consent from study participants and guardian in case of children (2-17 years) and assent from children aged 11-17 years.

3. Intention to participate in the study for a 2-year period.

4. No major co-morbid conditions, per the supervising clinician investigator, including underlying immunodeficiency, diabetes, liver diseases, renal disease, cardiac disease, and/or active malignancy.

Exclusion criteria

1. Suffering from diarrhoea or abdominal pain or vomiting in the past 24 hours or diarrhoea lasting for more than 2 weeks in the past 6 months.

2. History of taking another oral cholera vaccine.

3. History of taking any other live or killed enteric vaccine in the last 8 weeks.

Related Conditions & MeSH terms

• Cholera

Intervention

Biological:
• oral cholera vaccine or typhoid conjugate vaccine
One group will receive a 2 dose oral cholera vaccine, the other a typhoid conjugate vaccine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	International Centre for Diarrhoeal Disease Research, Bangladesh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vibrio cholerae infection	Serologic, PCR or culture evidence of infection	2 years