A phase 1, randomized, placebo-controlled trial, to evaluate the optimal dose of MV-LASV, a new vaccine against LASSA virus infection, regarding safety, tolerability and immunogenicity in healthy volunteers, consisting of an unblinded dose escalation and

Study title: 
A phase 1, randomized, placebo-controlled trial, to evaluate the optimal dose of MV-LASV, a new vaccine against LASSA virus infection, regarding safety, tolerability and immunogenicity in healthy volunteers, consisting of an unblinded dose escalation and
Long title: 
A phase 1, randomized, placebo-controlled trial, to evaluate the optimal dose of MV-LASV, a new vaccine against LASSA virus infection, regarding safety, tolerability and immunogenicity in healthy volunteers, consisting of an unblinded dose escalation and an observer-blinded treatment phase.
Date receipt dossier: 
23 Jul 2019
EudraCT number: 
2018-003647-40
Pharmaceutical study code: 
MV-LASV
Company / Sponsor: 
Themis Bioscience GmbH
Phase: 
I
Treated organism: 
Humans
Indication category: 
Infectious disease
Disease: 
LASSA virus infection
Therapeutic approach: 
Prevention
Genetic modification: 
Recombinant measles virus vaccine strain (Schwarz strain) expressing the envelop glycoprotein GPC and the nucleoprotein NP with a mutated exonuclease domein (GCP-rNP) from Lassavirus
Method of transfer of nucleic acid of interest: 
Not applicable
Administered biological material: 
Recombinant measles virus vaccine strain (Schwarz strain) expressing GCP-rNP from Lassavirus
Route of administration: 
Intramuscular
Locations in Belgium: 
U Antwerpen
Type of procedure: 
Contained use only
Current status: 
Authorized