Immunologic Responses to a Live Attenuated Oral Cholera Vaccine

Cholera Clinical Trial

Official title: Immunologic Responses to a Live Attenuated Oral Cholera Vaccine

Status Recruiting

Clinical Trial Summary

The primary objective of this study is to evaluate the antibody response to the cholera vaccine, Vaxchora®, in healthy subjects.

Investigators also seek to evaluate additional markers of the adaptive immune response including plasmablasts, activated B cells, memory B cells, and T cell responses in healthy subjects receiving cholera vaccine, produce monoclonal antibodies against cholera, and evaluate the safety and reactogenicity in healthy subjects receiving cholera vaccine.

Clinical Trial Description

Cholera is a life-threatening illness that causes diarrhea. Cholera is caused by eating or drinking the Vibrio cholera bacteria. Each year, there are about 1.3 to 4.0 million cases of cholera worldwide, resulting in 21,000 to 143,000 deaths. The bacteria is spread through water or food that has stool in it. Up to 50 countries with limited access to clean water are more likely to have outbreaks. In the United States most cases are linked to travel to these countries; however, there are 10-15 cases acquired in the United States each year because of undercooked seafood. Cholera spreads very easily. Illness from Cholera can vary from no symptoms to severe watery diarrhea that can cause death by dehydration in a healthy person within hours.

Vaxchora is a live attenuated cholera vaccine that protects against some cholera strains. It has been approved by the FDA since June 2016. Since October, 2016, this vaccine has been recommended for certain travelers 18 through 64 years of age going to cholera-affected areas. The purpose of this study is to look at the immune responses to the FDA approved cholera vaccine (Vaxchora®). ;

Related Conditions & MeSH terms

• Cholera

• NCT number: NCT03251495
• Study type: Interventional
• Source: Emory University
• Contact: Nadine Rouphael, MD
• Phone: 404-712-1370
• Email: nroupha@emory.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: August 29, 2017
• Completion date: June 30, 2025