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NOT YET RECRUITING
NCT07833436
PHASE1

A Trial to Evaluate the Safety, Immunogenicity and the Optimal Dose of MOPEVAC-Las Vaccine Candidate Against Lassa Fever

Sponsor: Institut Pasteur

View on ClinicalTrials.gov

Summary

Lassa fever is an acute viral disease belonging to the category of viral hemorrhagic fevers. It is endemic in West Africa. Outbreaks occur every year, and it is estimated that between 100 000 and 300 000 individuals are infected each year, with a fatality rate for symptomatic cases that ranges between 15 and 30%. There is no efficient treatment against the disease, as ribavirin, the only licensed therapy, is at best poorly efficient. MOPEVAC-Las is a live-attenuated vaccine candidate targeting Lassa virus. The objective of this phase 1 clinical trial is to evaluate the safety of the MOPEVAC-Las vaccine candidate on healthy volunteers. It will also evaluate the immunogenicity and optimal dose of the vaccine candidate. The main questions it aims to answer are: * What are the safety and tolerability of the MOPEVAC-Las vaccine candidate following two intramuscular injections in healthy volunteers ? * Are cell-mediated immunity and humoral immunity induced by the MOPEVAC-Las vaccine ? * What is the optimal dose of MOPEVAC-Las vaccine regarding safety, tolerability and immunogenicity ? Researchers will compare the MOPEVAC-Las vaccine candidate to a placebo (a look-alike substance that contains no drug).

Official title: A Randomized, Placebo-controlled Trial, to Evaluate the Safety, Immunogenicity and the Optimal Dose of MOPEVAC-Las Vaccine Candidate Against Lassa Fever, in Healthy Volunteers Consisting of an Unblinded Dose Escalation and a Blinded Treatment Phase

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2026-09-15

Completion Date

2028-12

Last Updated

2026-09-25

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Low dose MOPEVAC-Las vaccine

2 intramuscular injections of low dose MOPEVAC-Las vaccine candidate (5 x 10\^4 FFU per injection), on days 0 and 60

BIOLOGICAL

Intermediate dose MOPEVAC-Las vaccine

2 intramuscular injections of intermediate dose MOPEVAC-Las vaccine candidate (5 x 10\^5 FFU per injection), on days 0 and 60

BIOLOGICAL

High dose MOPEVAC-Las vaccine

2 intramuscular injections of high dose MOPEVAC-Las vaccine candidate (5 x 10\^6 FFU per injection), on days 0 and 60

DRUG

Saline Solution for Injection

2 intramuscular injections of placebo on days 0 and 60

Locations (1)

Centre d'Investigation Clinique en Vaccinologie Cochin-Pasteur

Paris, France