Study Comparing Safety and Immunogenicity of Intranasal COVID-19 Vaccine and mRNA Booster in Healthy Adults
NCT06821126 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 238
Last updated 2025-12-18
Summary
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 level.
Based on cumulative data collected up to Day 28 visit from the last included participant in the Phase I, the go/no-go decision for Phase II and selection of the optimal dose will be performed.
Phase II will then evaluate the immunogenicity of the selected intranasal dose of LVT-001 vaccine, compared to the standard of care of intramuscular COVID-19 mRNA Pfizer-BioNTech booster.
Conditions
- Healthy
Interventions
- BIOLOGICAL
-
LVT-001
Intranasal administration
- BIOLOGICAL
-
Cormirnaty
Intramuscular administration
Sponsors & Collaborators
-
University Hospital, Tours (Cosponsor)
collaborator UNKNOWN -
UMS 54 MART
collaborator UNKNOWN -
INSERM CIC 1415
collaborator UNKNOWN -
LovalTech
collaborator UNKNOWN -
INSERM U1259 MAVIVHe
collaborator UNKNOWN -
BioMAP - UMR ISP 1282 - Tours University - INRAE
collaborator UNKNOWN -
Virology unit, University Hospital, Tours
collaborator UNKNOWN -
I-REIVAC Innovative Clinical Research Network In Vaccinology
collaborator UNKNOWN -
ANRS, Emerging Infectious Diseases
lead OTHER_GOV
Principal Investigators
-
Zoha MAAKAROUN-VERMESSE, Dr. · University Hospital, Tours
-
Odile LAUNAY, Prof. · Cochin Hospital, Paris, France
-
Isabelle DIMIER-POISSON, Prof. · University, Tours, France
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-05-09
- Primary Completion
- 2026-10-31
- Completion
- 2028-03-31
Countries
- France
Study Locations
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