Actively Recruiting
Vaccine- and Infection-derived Correlates of Protection for Cholera
Led by Massachusetts General Hospital · Updated on 2026-04-08
1221
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
I
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating immune responses to cholera vaccines and natural infection to identify markers that predict protection against Vibrio cholerae, the bacteria that causes cholera. This trial addresses the current lack of accepted correlates of protection (CoPs), which are important for developing and licensing better cholera vaccines. The study involves healthy participants aged 2 to 80 years and aims to improve understanding of immune protection mechanisms following vaccination or natural infection. Participants will be randomly assigned to receive either a two-dose oral cholera vaccine or a typhoid conjugate vaccine as a control. The study will monitor antibody responses and immune signatures over a two-year period. Blood samples will be collected 12 times during follow-up to measure antibodies and detect any cholera infections. The researchers will compare immune responses between the vaccine and control groups, adjusting for factors like age, sex, and prior immunity. During the study, participants will provide blood samples and be monitored for cholera infection through laboratory tests such as cultures and PCR. The main outcome is occurrence of Vibrio cholerae infection during the two years post-vaccination. Researchers will analyze antibody levels and immune markers to identify which responses correlate with protection. Participants are expected to remain involved for the full two-year follow-up, allowing thorough assessment of vaccine-induced and natural immunity.
CONDITIONS
Brief Title
Vaccine- and Infection-derived Correlates of Protection for Cholera
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 2 to 80 years
- Provided informed consent (and assent if aged 11-17 years)
- Willing to participate in the study for 2 years
- No major co-morbid conditions such as immunodeficiency, diabetes, liver, kidney, heart diseases, or active cancer
You will not qualify if you...
- Diarrhea, abdominal pain, or vomiting in the past 24 hours, or diarrhea lasting more than 2 weeks in the past 6 months
- Previous receipt of any oral cholera vaccine
- Received any live or killed enteric vaccine in the last 8 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial vaccination period as per protocol
Participants receive either a 2 dose oral cholera vaccine or a typhoid conjugate vaccine and their immune responses are measured.
At least 2 visits for vaccine doses and immunoprofiling assessments
Duration - 2 years
Participants are monitored for up to 2 years to identify cholera infections and evaluate correlates of protection.
Periodic visits over 2 years for infection monitoring and immune response assessments
Trial Site Locations
Total: 1 location
1
Icddr,B
Dhaka, Bangladesh
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here