Study title:
Open-label, Single-arm Phase 1 Study to Evaluate the Shedding, Biodistribution, Safety and Immunogenicity of Ad26.RSV.preF Vaccine in Adults
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:
5 oct 2018
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