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).
Males and females between the ages of 18 and 55 years (at the time of consent).
Healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments.
Participant with a body mass index (BMI) between 18,5 kg/m2 and 30.0 kg/m2.
Provide written informed consent before initiation of any study procedures.
Subjects previously infected by Lassa Virus.
Previous vaccination with an investigational Lassa fever vaccine.
Subjects who travelled in the past 12 months prior the first injection or plan to travel during the study in a Lassa-endemic country .
Subjects who used to live in a Lassa-endemic country, or who are regularly traveling to a Lassa-endemic country.
Sequential
Low dose MOPEVAC-Las vaccine
Biological/Vaccine2 intramuscular injections of low dose MOPEVAC-Las vaccine candidate (5 x 10\^4 FFU per injection), on days 0 and 60
Intermediate dose MOPEVAC-Las vaccine
Biological/Vaccine2 intramuscular injections of intermediate dose MOPEVAC-Las vaccine candidate (5 x 10\^5 FFU per injection), on days 0 and 60
High dose MOPEVAC-Las vaccine
Biological/Vaccine2 intramuscular injections of high dose MOPEVAC-Las vaccine candidate (5 x 10\^6 FFU per injection), on days 0 and 60
Saline Solution for Injection
Drug2 intramuscular injections of placebo on days 0 and 60
Rate of solicited and unsolicited Adverse Events (AEs) during the treatment period up to 28 days after each injection.
Measurement of functional CD4+ and CD8+ T- cells to assess cell-mediated immunity specific for MOPEVAC-Las
Measurement of anti-LASV antibodies determined by ELISA assay
Quantification of functional, neutralizing antibodies via Virus Neutralization Test (VNT)
Rate of serious adverse events (SAEs), serious adverse reactions (SARs), suspected unexpected serious adverse reactions (SUSARs) and adverse events of special interest (AESI)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
