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

Date receipt dossier

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

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