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Clinical Trial 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


Clinical Trial 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, in Uganda and Kenya. The study will enroll 125 eligible participants randomized 4:1 to receive the cAd3-Marburg vaccine at 1.0 × 10^11 PU dose or placebo (0.9% sodium chloride (NaCl) solution) at Day 1, intramuscularly in deltoid muscle. Participants will be screened for eligibility up to 28 days before enrollment. Enrollment will be staggered, starting with healthy adults 18 to 50 years of age (inclusive). Upon enrollment of minimum 25 younger adult participants (sentinel), the safety data up to 7 days post vaccination of these 25 sentinel participants will be reviewed by the independent DSMB. Progression to enrollment of the older adults (>50 to 70 years of age) will be dependent on the unblinded review of the Data Safety Monitoring Board (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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05817422
Study type Interventional
Source Albert B. Sabin Vaccine Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 19, 2023
Completion date May 1, 2025

See also
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Completed NCT00605514 - Ebola and Marburg Virus Vaccines Phase 1
Recruiting NCT06265012 - Study to Evaluate the Recombinant Vesicular Stomatitis Virus (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects Phase 1
Completed NCT00997607 - Evaluating an Ebola and a Marburg Vaccine in Uganda Phase 1
Completed NCT03800173 - A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430 Phase 1