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

NCT06128382 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-03-24

No results posted yet for this study

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)

Conditions

  • Coronavirus

Interventions

BIOLOGICAL

OVX033

One single administration intramuscularly on Day 1

BIOLOGICAL

Saline solution

One single administration intramuscularly on Day 1

Sponsors & Collaborators

  • CIC 1417 Cochin Pasteur Hôpital Cochin Paris France

    collaborator UNKNOWN

  • Osivax

    lead INDUSTRY

Principal Investigators

  • Odile Launay, MD · CIC Cochin Pasteur CIC 1417 Hôpital Cochin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2024-07-08
Completion
2024-11-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06128382 on ClinicalTrials.gov