Long title
Open-label, Single-arm Phase 1 Study to Evaluate the Shedding, Biodistribution, Safety and Immunogenicity of Ad26.RSV.preF Vaccine in Adults
Date receipt dossier
EudraCT number
2018-003261-34
Company / Sponsor
Janssen Vaccines & Prevention B.V.
Phase
I
Treated organism
Humans
Indication category
Infectious disease
Disease
Acute respiratory illness caused by RSV
Therapeutic approach
Prevention
Genetic modification
Replication deficient Adenovirus serotype 26 containing a deoxyribonucleic acid (DNA) transgene that encodes the pre-fusion conformation-stabilized F protein (pre-F) derived from the RSV A2 strain
Method of transfer of nucleic acid of interest
not applicable
Administered biological material
Recombinant replication deficient adenovirus serotype 26 (Ad26.RSV.preF)
Route of administration
Intramuscular
Locations in Belgium
Janssen Pharmaceutica N.V. (Jan Palfijn ziekenhuis)
Type of procedure
Contained use only
Current status
Under evaluation