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
EudraCT number
2018-003647-40
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
Pharmaceutical study code
MV-LASV