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drugset / Trial / NCT06821126

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

NCT06821126 ↗

Phase 1/2 Recruiting 238 enrolled ANRS, Emerging Infectious Diseases BioMAP - UMR ISP 1282 - Tours University - INRAE · collabI-REIVAC Innovative Clinical Research Network In Vaccinology · collabINSERM CIC 1415 · collabINSERM U1259 MAVIVHe · collabLovalTech · collabUMS 54 MART · collabUniversity Hospital, Tours (Cosponsor) · collabVirology unit, University Hospital, Tours · collab
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2025-05-09
Primary completion
2026-10
Completion
2028-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cormirnaty Unknown — Intramuscular
Subject LVT-001 Vaccine 20 ug Intranasal
Subject LVT-001 Vaccine 60 ug Intranasal
Subject LVT-001 Vaccine 120 ug Intranasal

Indications

No indication recorded.