RecruitingPhase 1Phase 2NCT06821126

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

Randomized, Controlled, Multicenter Phase I/II Study Comparing the Safety and Immunogenicity of a Booster Dose of an Intranasal COVID-19 Vaccine Expressing SARS-CoV-2 N/S Recombinant Proteins With a Booster Dose of COVID-19 mRNA Vaccine in Healthy Adults (MUCOBOOST)

Sponsor

ANRS, Emerging Infectious Diseases

Enrollment

238 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Cormirnaty and a biological treatment called LVT-001 for people with healthy. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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