Phase I study to evaluate the safety and immunogenicity of a bivalent recombinant vaccine against human cytomegalovirus (HCMV).

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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