Lassa Fever

C105 - Phase 2 Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of rVSVΔG- LASVGPC Vaccine in Adults and Children Residing in West Africa study

Objectives

Primary

• To evaluate the safety and tolerability of rVSVΔG-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children

Secondary

• To determine LASV-GPC-specific antibody responses induced by rVSVΔG-LASV-GPC vaccine
• To determine neutralizing LASVGPC-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

• To explore the characteristics of the immune responses induced by rVSVΔGLASV-GPC vaccine in a subset of participants

Sponsor

IAVI

Country

Liberia, Ghana & Nigeria

Status

Enrollment

Tentative End date

September 2027

Who's involved outside MSF?

Epicentre, IAVI, CEPI, IQVIA,

Our role

External Monitoring

Since the isolation of the Lassa mammarenavirus (LASV) in 1969, the disease has continued to cause seasonal morbidity and mortality. 300'000 annual infections are estimated in West Africa, making LASV a primary cause of haemorrhagic fever worldwide. A crucial step to assess the feasibility and prepare for potential future Lassa vaccine efficacy trials is to gather epidemiological data on the background rates of infection and disease due to LASV in endemic areas, because incidence & spatial distribution of Lassa Fever (LF) is likely to be significantly underestimated based on existing data, due to gaps in diagnostics, surveillance and access to health services. The aim of this project, "Prospective Multi-site cohort study to estimate the incidence of infection and disease due to Lassa Fever Virus in westafrican countries", is to conduct epidemiological cohort study that will assess LF disease and LASV incidence to determine the feasibility of future Phase IIb or III clinical trials for assessing the efficacy of LF vaccine or therapeutic candidates. Strategic aims are to

1. provide information on prevalence and incidence and to inform the design of future studies,
2. Identify sites, 
3. Assess and strengthen the site and investigator capability and capacity.

Objective

For each Lassa-endemic country participating in the study, separately :

1. to assess the incidence rate of symptomatic confirmed LF ;
2. to estimate the incidence rate of LASV infection.

Methodology

A prospective multisite cohort study:

1. LF disease cohort: data on LF cases, signs & symptoms will be collected in a standardized manner
2. LASV infection cohort: data on study participant LASV serostatus will be collected

Who's Involved Besides MSF?

CEPI, BNITM, P95, Nigeria, Benin, Sierra Leone, Liberia, Guinea, Tulane University, NCDC, and Others

Country

Nigeria, Benin, Sierra Leone, Liberia, Guinea

Status

Recruitment and follow-up ongoing

Tentative End date

December 2024

Our Role

Scientific Oversight, Data Management, Statistics