Cholera Clinical Trial
Official title:
Correlates of Protection for Cholera
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01895855 -
Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera
|
Phase 3 | |
| Completed |
NCT01339845 -
Introduction of Cholera Vaccine in Bangladesh
|
N/A | |
| Recruiting |
NCT05829772 -
Impact Study of Cholera Vaccination in Endemic Areas - Seroprevalence
|
||
| Completed |
NCT04760236 -
Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™
|
Phase 3 | |
| Recruiting |
NCT04326478 -
Single Dose Azithromycin to Prevent Cholera in Children
|
Phase 2 | |
| Recruiting |
NCT06104345 -
Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines
|
Phase 4 | |
| Completed |
NCT02928341 -
Impact Evaluation of Urban Water Supply Improvements on Cholera and Other Diarrhoeal Diseases in Uvira, Democratic Republic of Congo
|
N/A | |
| Completed |
NCT02864433 -
Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts
|
||
| Recruiting |
NCT06003816 -
Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)
|
N/A | |
| Not yet recruiting |
NCT05771779 -
Co-administration Study of OCV, TCV and MR
|
Phase 3 | |
| Completed |
NCT04150250 -
Cholera Anti-Secretory Treatment Trial
|
Phase 2 | |
| Terminated |
NCT00624975 -
Safety and Immunogenicity of Peru-15 Vaccine When Given With Measles Vaccine in Healthy Indian and Bangladeshi Infants
|
Phase 2 | |
| Completed |
NCT00226616 -
Zinc Supplementation in Cholera Patients
|
Phase 3 | |
| Completed |
NCT03373669 -
Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine
|
Phase 4 | |
| Completed |
NCT02100631 -
A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults
|
Phase 3 | |
| Completed |
NCT02094586 -
A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
|
Phase 3 | |
| Completed |
NCT01823939 -
PK Study of iOWH032 in Adult Male/Female Healthy Volunteers & Adult Males With Cholera
|
Phase 1 | |
| Completed |
NCT01365442 -
Pilot Introduction of Oral Cholera Vaccine in Orissa, India
|
N/A | |
| Completed |
NCT00128011 -
Safety and Immunogenicity of a New Formulation of a Bivalent Killed, Whole-Cell Oral Cholera Vaccine
|
Phase 2 | |
| Completed |
NCT00672308 -
Efficacy of Benefiber-Added, Reduced-Osmolarity WHO-ORS in the Treatment of Cholera in Adults
|
Phase 2 |