NCT05724472

Evaluation of Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine in Adults With Good General Health

A Phase 1, Single-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine at 3 Dose Levels in Adults in Good General Health

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Single-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine at 3 Dose Levels in Adults in Good General Health

Detailed description

The purpose of this study is to provide the needed safety and immunogenicity data to support rapid deployment of the SEBOV vaccine against an ongoing or future outbreak. The intervention will be a single dose and will either be study vaccine named rVSVΔG-SEBOV-GP Vaccine, or placebo (a placebo is an inactive substance or other intervention that looks the same as and is given the same way as study vaccine or treatment being tested) There are 3 group in this study, each group has different vaccine doses. Group 1 starts with the lowest dose of the study vaccine and each subsequent group Groups 2 and Group 3 gets a higher dose of the study vaccine. Approximately 36 participants will be included in the study. The participant will be unaware of the treatment given between placebo and study vaccine. Participants will be screened up to 14 days before IP administration and will be followed for 6 months after IP administration. The anticipated study duration for each participant in Groups 1 through 3 is approximately 6.5 months from screening through last study visit.

Conditions

• Ebola Sudan Virus Disease

Interventions

Type	Name	Description
DRUG	rVSV∆G-SEBOV-GP Vaccine or Placebo	rVSV∆G-SEBOV-GP Vaccine or Placebo

Timeline

• Start date: 2023-06-19
• Primary completion: 2024-01-09
• Completion: 2024-01-09
• First posted: 2023-02-13
• Last updated: 2024-11-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study