NCT06128382

First-in-human Study to Evaluate the Safety and Immunogenicity of Three Dose Levels of the OVX033 Coronavirus Vaccine Candidate in Healthy Volunteers

A First-in-human Phase 1, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of Three Dose Levels of the OVX033 Vaccine, After Intramuscular Administration in Healthy Subjects Aged 18-49 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Osivax · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This first-in-human clinical trial is designed to evaluate the safety and immunogenicity of one administration of OVX033 coronavirus vaccine at different dose levels (100µg, 250µg and 500µg)

Detailed description

This trial is a first-in-human phase 1, single center, randomized, double-blind, placebo-controlled study in 48 adult subjects to evaluate the safety and immunogenicity of OVX033 sarbecovirus vaccine at different dose levels (100µg, 250µg and 500µg). One single dose of OVX033 vaccine or of Placebo will be administered intramuscularly in healthy subjects aged 18-49 years.

Conditions

• Coronavirus

Interventions

Type	Name	Description
BIOLOGICAL	OVX033	One single administration intramuscularly on Day 1
BIOLOGICAL	Saline solution	One single administration intramuscularly on Day 1

Timeline

• Start date: 2024-01-08
• Primary completion: 2024-07-08
• Completion: 2024-11-29
• First posted: 2023-11-13
• Last updated: 2025-03-24

Locations

1 site across 1 country: France