Study title:
Phase I study to evaluate the safety and immunogenicity of a bivalent recombinant vaccine against human cytomegalovirus (HCMV).
Date receipt dossier:
22 mar 2016
EudraCT number:
2016-000632-17
Company / Sponsor:
Hookipa Biotech AG
Phase:
I
Treated organism:
Humans
Indication category:
Vaccination
Disease:
Cytomegalovirus (CMV) infection
Therapeutic approach:
Prevention
Genetic modification:
Two replication-deficient lymphocytic choriomeningitidis virus (rLCMV) vectors, one expressing a truncated gBprotein of HCMV and one expressing the pp65 protein of the human CMV
Method of transfer of nucleic acid of interest:
Not applicable, rLCMV vectors
Administered biological material:
HB-101: Bivalent vaccine containing two recombinant, replication-deficient rLCMV vectors
Route of administration:
Intramuscular
Locations in Belgium:
UZ Gent
Type of procedure:
Contained use only
Current status:
Authorized