Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-01-02 @ 5:12 AM
Study NCT ID:
NCT06620003
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2024-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
Albert B. Sabin Vaccine Institute
Organization:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
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:
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 2 study to evaluate safety, tolerability, and immunogenicity of a single dose of cAd3-Marburg Vaccine in healthy adults 18 to 70 years of age, in a US-based population. The study will enroll 200 eligible participants randomized 4:1 to receive the cAd3-Marburg Vaccine at 1.0 × 10\^11 PU/dose or placebo (normal saline; 0.9% sodium chloride (NaCl) solution for injection) 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 will conclude at the end of study visit on Day366 to access cellular immunity. All participants will also be contacted telephonically on Days 4 and 42 (unless a clinic visit is medically indicated, or participant does not have a phone contact) for safety follow-up.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 75A05119C00055 | OTHER_GRANT | DHHS/ASPR-BARDA | View |