Study Comparing Safety and Immunogenicity of Intranasal COVID-19 Vaccine and mRNA Booster in Healthy Adults
Recruiting
Phase 1
Phase 2
Interventional Study
Healthy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 238 (estimated)
- Sponsor
- ANRS, Emerging Infectious Diseases · Government
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About This Trial
This Phase I/II trial in France evaluates safety and immunogenicity of a booster dose of an intranasal COVID-19 vaccine (LVT-001) versus a booster dose of a COVID-19 mRNA vaccine (Pfizer-BioNTech) in healthy adult volunteers.
As a first-in-human trial, Phase I will assess the safety and immunogenicity of three escalating doses of the LVT-001 vaccine across 3 cohorts of 12 volunteers per dose leve…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Written informed consent obtained from the participant.
2. Be male or female between the ages of:
1. ≥ 18 and ≤ 55 years for phase I
2. ≥ 18 and ≤ 60 years for phase II.
3. Good general health as determined at the discretion of the investigator (vital signs, medical hi…
Contacts