A randomized, double-blind, placebo-controlled Phase 1/2a study to evaluate the safety, reactogenicity, and immunogenicity of Ad26COVS1 in adults aged 18 to 65 years, inclusive and adults aged 65 years and older.

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Study title: 
A randomized, double-blind, placebo-controlled Phase 1/2a study to evaluate the safety, reactogenicity, and immunogenicity of Ad26COVS1 in adults aged 18 to 65 years, inclusive and adults aged 65 years and older.
Long title: 
A randomized, double-blind, placebo-controlled Phase 1/2a study to evaluate the safety, reactogenicity, and immunogenicity of Ad26COVS1 in adults aged 18 to 65 years, inclusive and adults aged 65 years and older.
Date receipt dossier: 
25 juin 2020
EU record number: 
J&JBE-018_004
EudraCT number: 
2020-001483-28
Pharmaceutical study code: 
Ad26-COVID19
Company / Sponsor: 
Janssen Vaccines & Prevention B.V.
Phase: 
I/II a
Treated organism: 
Humans
Indication category: 
Infectious disease
Disease: 
COVID-19
Therapeutic approach: 
Prevention
Genetic modification: 
Recombinant Adenoviral vector serotype 26 expressing the spike glycoprotein 1 from SARS-CoV2
Method of transfer of nucleic acid of interest: 
Not applicable
Administered biological material: 
Recombinant Adenoviral vector serotype 26 expressing the spike glycoprotein 1 from SARS-CoV2
Route of administration: 
Intramuscular
Locations in Belgium: 
Janssen Pharmaceutica N.V., Clinical Pharmacology Unit (Jan Palfijn ziekenhuis)
Type of procedure: 
Contained use only
Current status: 
Under evaluation