NCT04794218

A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath

A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 51 Years
• Healthy volunteers: Accepted

Summary

A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health

Detailed description

This is a Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health. Approximately 110 participants (88 active product and 22 placebo recipients) will be included in the study Participants will be screened up to 42 days before IP administration and will be followed for 12 months after IP administration.

Conditions

• Lassa Fever
• Lassa Virus Infection

Interventions

Type	Name	Description
DRUG	rVSV∆G-LASV-GPC	2 × 10\^4 pfu delivered intramuscularly
DRUG	rVSV∆G-LASV-GPC	2 × 10\^5 pfu delivered intramuscularly
DRUG	rVSV∆G-LASV-GPC	2 × 10\^6 pfu delivered intramuscularly
DRUG	rVSV∆G-LASV-GPC	2 × 10\^7 pfu delivered intramuscularly
OTHER	Placebo/Diluent	N/A delivered intramuscularly

Timeline

• Start date: 2021-06-23
• Primary completion: 2023-12-19
• Completion: 2024-03-01
• First posted: 2021-03-11
• Last updated: 2024-01-18

Locations

4 sites across 2 countries: United States, Liberia

Regulatory

• FDA-regulated drug study