NCT04885361

To Evaluate the Safety, and Immunogenicity of Vaccine Candidate Against COVID-19, in Healthy Adults

A Randomized, Open Label, Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of OSE-13E, a Multiepitope-based Vaccine Candidate Against COVID-19, in Healthy Adults (COVEPIT-3)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: OSE Immunotherapeutics · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The proposed study is a phase 1 study which will evaluate the safety, reactogenicity and immunogenicity of two doses regimen of CoVepiT vaccine (OSE-13E) in the population of n=48 healthy volunteers 18 to 45 (inclusive) years old, vaccinated or not by authorized COVID-19 vaccine. Study will be open label and will be randomized 1:1 in two parallel study arms receiving either one single dose or two doses separated by 21 days. First 4 subjects will serve as sentinel cohort and 7 days reactogenicity data of these subjects will be reviewed by the independent safety monitoring committee (SMC) before proceeding to the vaccination of remaining volunteers. The progress of the study will be overviewed by a safety monitoring committee (SMC). The CoVepiT vaccine is a peptide-based vaccine aiming to induce CD8+T-cell-mediated immune response against 11 different proteins of SARS-CoV-2 virus.

Conditions

• Coronavirus Disease (COVID-19)

Interventions

Type	Name	Description
BIOLOGICAL	CoVepiT (OSE13E)	Study will be open label and will be randomized 1:1 in two parallel study arms receiving either one single dose or two doses separated by 21 days.

Timeline

• Start date: 2021-05-26
• Primary completion: 2021-09-30
• Completion: 2022-03-31
• First posted: 2021-05-13
• Last updated: 2021-06-09

Locations

1 site across 1 country: Belgium