Study 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 Oth
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:
2 Dec 2019
EudraCT number:
2018-000200-41
Pharmaceutical study code:
JNJ-65195208 and JNJ-63682918 and JNJ-63682918
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