Cholera Clinical Trial
Official title:
Safety and Immunogenicity of a Killed, Oral Cholera Vaccine in Indian Subjects in Eastern Kolkata, West Bengal
The purpose of the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal, India.
Cholera remains to be a serious public health problem worldwide. In the mid-1980s following
technology transfer from Sweden, Vietnamese scientists developed and produced an oral killed
monovalent cholera vaccine for Vietnam's public health programs. A 2-dose regimen of this
vaccine has been shown to be safe and efficacious. Subsequently, a bivalent vaccine was
developed containing the newly emergent O139 V. cholerae. This vaccine has several
advantages over the existing Swedish vaccine. It confers protection against the El Tor
biotype in younger children, is considerably less expensive, does not require a buffer
during administration and does not require strict cold chain requirements. However, this
vaccine is not licensed for use in countries other than Vietnam.
Through IVI, an agreement between VABIOTECH in Hanoi and Shantha Biotechnics PVT, LTD in
India has been reached that will make the bivalent vaccine available in India. A
double-blind randomized phase III trial in a cholera-endemic area would be necessary to
demonstrate the efficacy of this vaccine in other settings. This would pave the way for the
introduction of the vaccine into the national immunization programme in India and the
internationalization of this vaccine and licensure in other countries where it is needed.
Prior to the phase III trial, a phase II study will be performed among adults and children.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| 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 | |
| Not yet recruiting |
NCT06455852 -
Correlates of Protection for Cholera
|
N/A | |
| 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 |
NCT02094586 -
A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
|
Phase 3 | |
| Completed |
NCT02100631 -
A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older 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 |