Long title
A randomized Double-blind, Placebo-controlled First-in-Human, Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Otherwise Healthy Women with HPV16 or 18 Infection of the Cervix.
Date receipt dossier
EudraCT number
2018-000200-41
Company / Sponsor
Janssen-Cilag International NV
Phase
I/II a
Treated organism
Humans
Indication category
Infectious disease
Disease
Human papillomavirus
Therapeutic approach
Prevention
Genetic modification
Recombinant Adenovirus serotype 26 and MVA Bavarian Nordic strain
Method of transfer of nucleic acid of interest
Not applicable
Administered biological material
Recombinant Ad26 expressing HPV16/18 E6 en E7 antigens and MVA Bavarian Nordic strain expressing HPV16/18 E6 en E7 antigens
Route of administration
Intramuscular
Locations in Belgium
UZ Leuven
Type of procedure
Contained use only
Current status
Authorized
Pharmaceutical study code
JNJ-65195208 and JNJ-63682918 and JNJ-63682918