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

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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 déc 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