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