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

EU record number

J&JBE-018_004

EudraCT number

2020-001483-28

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

Pharmaceutical study code

Ad26-COVID19

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