Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620003
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
A Trial to Evaluate Safety Tolerability and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral Vectored Marburg Virus Vaccine in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo-Controlled Trial to Evaluate Safety Tolerability and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral Vectored Marburg Virus Vaccine in Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 2 Randomized Double-blind Placebo-Controlled Trial to Evaluate Safety Tolerability and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral Vectored Marburg Virus Vaccine in Healthy Adults
Detailed Description:
This is a multi-center double-blinded placebo-controlled Phase II study to evaluate safety tolerability and immunogenicity of a single dose of cAd3-Marburg vaccine in healthy adults up to 70 years of age The study will enroll 200 eligible participants randomized 41 to receive the cAd3-Marburg vaccine at 10 1011 PU dose or placebo 09 sodium chloride NaCl solution at Day 1 intramuscularly in deltoid muscle Participants will be screened for eligibility up to 28 days before enrollment Safety data will be periodically reviewed by an independent DSMB Safety and immunogenicity will be assessed at Days 1 8 15 29 85 169 and will conclude at the end of study visit on Day 366 PBMCs will be collected from a subset of 40 subjects on days 1 15 29 169 and 366 to access cellular immunity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None