NCT05868733

A Lassa Fever Vaccine Trial in Adults and Children Residing in West Africa

A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults and Children Residing in West Africa

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 612 (estimated)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Months – 70 Years
• Healthy volunteers: Accepted

Summary

A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults and Children Residing in West Africa

Detailed description

rVSVΔG-LASV-GPC is a candidate vaccine that has been shown to be safe and protects against LF disease in animals. The vaccine was studied studied in a Phase 1 trial and has been well tolerated and immunogenic. This Phase 2 trial will add to data from the Phase 1 trial to establish a broader profile of safety and immunogenicity in adults and expand the population to include a subset of adults with HIV infection as well as older adults and healthy children, in preparation for an efficacy trial in West Africa. Primary Objective: • To evaluate the safety and tolerability of rVSVΔG-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children Secondary Objectives: • To determine binding LASV-GPC-specific antibody responses induced by rVSVΔG-LASV-GPC vaccine • To determine neutralizing LASV-GPC-specific antibody responses induced by rVSVΔG-LASV-GPC vaccine in a subset of participants in each group • To evaluate the magnitude and duration of the rVSVΔG-LASV-GPC vaccine viremia in plasma in a subset of participants. • To evaluate the magnitude and duration of the rVSVΔG-LASV-GPC vaccine shedding in saliva and urine, and possibly semen and cervicovaginal fluid, in a subset of participants Exploratory Objective • To explore the characteristics of the immune responses induced by rVSVΔG-LASV-GPC vaccine in a subset of participants

Conditions

• Lassa Fever

Interventions

Type	Name	Description
DRUG	Day 1 Lower Dose (2×106 pfu)	rVSV∆G-LASV-GPC
DRUG	Day 1 Higher Dose (1×107 pfu)	rVSV∆G-LASV-GPC
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-03-06
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2023-05-22
• Last updated: 2025-05-11

Locations

3 sites across 3 countries: Ghana, Liberia, Nigeria

Regulatory

• FDA-regulated drug study