Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455852
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-07
Brief Title:
Correlates of Protection for Cholera
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Correlates of Protection for Cholera
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoP
Brief Summary:
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 measuresvariables 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
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 measuresvariables 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None