International AIDS Vaccine Initiative
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
Lassa Fever
Day 1 Lower Dose (2×106 pfu)
Day 1 Higher Dose (1×107 pfu)
Placebo
Phase 2
rVSVΔG-LASV-GPC is a candidate vaccine that has been shown to be safe and protects against LF disease in animals. The vaccine is now being studied in an ongoing Phase 1 trial and has to date 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}}
Study Type : | Interventional |
Estimated Enrollment : | 612 participants |
Masking : | Triple |
Masking Description : | Study staff and participants will be blinded in terms of active product versus placebo. |
Primary Purpose : | Prevention |
Official Title : | 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 |
Actual Study Start Date : | March 6, 2024 |
Estimated Primary Completion Date : | August 2026 |
Estimated Study Completion Date : | February 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1A Healthy Adults, 18-70yrs |
Drug: Day 1 Lower Dose (2×106 pfu) Drug: Placebo |
Experimental: Cohort 2A HIV-infected Adults, 18-50yrs |
Drug: Day 1 Lower Dose (2×106 pfu) Drug: Placebo |
Experimental: Cohort 3A Adolescents, 12 17yrs |
Drug: Day 1 Lower Dose (2×106 pfu) Drug: Placebo |
Experimental: Cohort 4A Children, 6-11yrs |
Drug: Day 1 Lower Dose (2×106 pfu) Drug: Placebo |
Experimental: Cohort 5A Children, 18mos-5yrs |
Drug: Day 1 Lower Dose (2×106 pfu) Drug: Placebo |
Experimental: Cohort 1B Healthy Adults, 18-70yrs |
Drug: Day 1 Higher Dose (1×107 pfu) Drug: Placebo |
Experimental: Cohort 2B HIV-infected Adults,18-50yrs |
Drug: Day 1 Higher Dose (1×107 pfu) Drug: Placebo |
Experimental: Cohort 3B Adolescents, 12 17yrs |
Drug: Day 1 Higher Dose (1×107 pfu) Drug: Placebo |
Experimental: Cohort 4B Children, 6-11yrs |
Drug: Day 1 Higher Dose (1×107 pfu) Drug: Placebo |
Experimental: Cohort 5B Children, 18mos-5yrs |
Drug: Day 1 Higher Dose (1×107 pfu) Drug: Placebo |
Ages Eligible for Study: | 18 Months to 70 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Noguchi Memorial Institute for Medical Research (NMIMR)
Accra, Ghana,
Recruiting
PREVAIL_ John F. Kennedy Medical Center (JFK)
Monrovia, Liberia,
Recruiting
Walter Reed Program - Nigeria
Wuse, Nigeria,