Vaccine- and Infection-derived Correlates of Protection for Cholera.

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jun 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how our bodies respond to a cholera vaccine, specifically looking for markers that show when a person is protected from cholera infection. Cholera is caused by the bacteria Vibrio cholerae, which can lead to severe illness and even death. Currently, there aren't accepted ways to measure if a vaccine will be effective, which makes it hard to develop new and better vaccines. By examining how different individuals respond to the inactivated oral cholera vaccine (OCV) and comparing them to a control group receiving a typhoid vaccine, researchers hope to identify important immune responses that can help speed up the creation of effective cholera vaccines.

To participate in this trial, individuals aged 2 to 80 years can enroll, as long as they are healthy and free from certain medical conditions like diabetes or cancer. Participants will be randomly assigned to receive either the cholera vaccine or the control vaccine, and they will provide blood samples over a two-year period to help researchers track their immune responses and check for any signs of cholera infection. This study is not yet recruiting participants, but it aims to contribute significantly to our understanding of cholera immunity and vaccine development, ultimately helping to reduce cholera-related illness and deaths.

Gender

ALL

Eligibility criteria

• • 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.