Study title:
A phase IIa partial blind, placebo-controlled clinical trial to evaluate the safety and immunogenicity of the Ad5-EBOV in healthy adults aged between 18 and 60 years in Belgium.
Long title:
A phase IIa partial blind, placebo-controlled clinical trial to evaluate the safety and immunogenicity of the Ad5-EBOV in healthy adults aged between 18 and 60 years in Belgium.
Date receipt dossier:
13 Mar 2019
EU record number:
EBOVEU001
EudraCT number:
2018-003912-29
Pharmaceutical study code:
Ad5-EBOV
Company / Sponsor:
Bejing Institute of Biotechnology, CanSino Biologics Inc,
Phase:
IIa
Treated organism:
Humans
Indication category:
Infectious disease
Disease:
Ebola virus infection
Therapeutic approach:
Prevention
Genetic modification:
Recombinant Adenoviral vector serotype 5 expressing the envelop glycoprotein from Ebola virus (Zaïre-Makona)
Method of transfer of nucleic acid of interest:
Not applicable
Administered biological material:
Recombinant Adenoviral vector serotype 5 expressing the envelop glycoprotein from Ebola virus (Zaïre-Makona)
Route of administration:
Intradermal & Intramuscular
Locations in Belgium:
U Antwerpen
Type of procedure:
Contained use only
Current status:
Authorized