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RECRUITING
NCT06821126
PHASE1/PHASE2

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

Sponsor: ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

238

Start Date

2025-05-09

Completion Date

2028-03

Last Updated

2025-12-18

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

LVT-001

Intranasal administration

BIOLOGICAL

Cormirnaty

Intramuscular administration

Locations (5)

CHU Dijon Bourgogne - Centre d'Investigation Clinique 1432

Dijon, France

HCL - Hôpital de la Croix-Rousse - Service des Maladies Infectieuses et Tropicales

Lyon, France

APHP - Hôpital Cochin - Centre d'Investigation Clinique de Vaccinologie Cochin-Pasteur 1417

Paris, France

CHU de Saint-Etienne - Service des Maladies Infectieuses

Saint-Priest-en-Jarez, France

CHRU de Tours - Centre d'Investigation Clinique 1415

Tours, France