Study Comparing Safety and Immunogenicity of Intranasal COVID-19 Vaccine and mRNA Booster in Healthy Adults

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.

NCT Number	NCT06821126
Lead Sponsor	ANRS, Emerging Infectious Diseases Collaborators: University Hospital, Tours (Cosponsor), UMS 54 MART, INSERM CIC 1415, LovalTech, INSERM U1259 MAVIVHe, BioMAP - UMR ISP 1282 - Tours University - INRAE, Virology unit, University Hospital, Tours, I-REIVAC Innovative Clinical Research Network In Vaccinology
Conditions	Healthy
Enrollment	238 participants
Start Date	2025-05-09
Primary Completion	2026-10 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2025-12-18