NCT06036602

Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults

A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Albert B. Sabin Vaccine Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus 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-Sudan Ebolavirus 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-Sudan Ebolavirus 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 Data Safety Monitoring Board (DSMB). Progression to enrollment of the older adults (\>50 to 70 years of age) will be dependent on the unblinded review of the 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.

Conditions

• Ebola Sudan Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	cAD3-Sudan Ebolavirus Vaccine	The recombinant chimpanzee adenovirus Type 3-vectored Sudan Ebolavirus vaccine, (cAd3-EBO S) is composed of a cAd3 vector that expresses wild type glycoprotein (WT GP) from the Sudan Gulu ebolavirus strain.
OTHER	Placebo	0.9% NaCl solution for injection.

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-11-08
• Completion: 2025-11-08
• First posted: 2023-09-14
• Last updated: 2026-03-04

Locations

2 sites across 2 countries: Kenya, Uganda

Regulatory

• FDA-regulated drug study