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

Study acronym: MUCOBOOST
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary endpoints revised (6)
    • Start date changed from estimate of May 2025 to May 9, 2025
    • Secondary endpoints revised (13)
    • Eligibility criteria expanded, about 4 words
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 5 of 5 sites
    v3
  3. Start date: Mar 2025 to May 2025v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Healthy
Related terms COVID-19
Enrollment 238 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov