Study of Oral Cholera Vaccine and Typhoid Vaccine to Identify Immune Markers Protecting Against Cholera Infection

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.

Vaccine- and Infection-derived Correlates of Protection for Cholera