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.

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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