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)
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.
• Written informed consent obtained from the participant.
• Be male or female between the ages of:
∙ ≥ 18 and ≤ 55 years for phase I
‣ ≥ 18 and ≤ 60 years for phase II.
• Good general health as determined at the discretion of the investigator (vital signs, medical history, and physical examination).
• BMI: 18,5 Kg/m2 ≤ BMI ˂30Kg/m2.
• Received at least 3 doses of a COVID-19 mRNA vaccine, last booster dose received at least 6 months prior to trial vaccine administration OR 2 doses of a COVID-19 mRNA vaccine and confirmed SARS-CoV-2 infection at least 6 months prior to inclusion in the trial.
• Has expressed interest and availability to meet the trial requirements.
• For a woman of childbearing potential, plan to be non-pregnant AND use of highly effective contraception from screening until the end of the trial.
• Agree to abstain from donating blood/plasma or any other bodily fluids from the time of vaccination until 1 year after vaccination (only for LVT-001 vaccine).
• Agree to stay in the geographical area of one of the clinical sites for the duration of the trial.
⁃ Agree to implement barrier measures as much as possible (washing hands and wearing a mask) against COVID-19 and respiratory infections between D0 and D28.
⁃ Agree to be registered in the computerized file of the Ministry of Health (VRB).
⁃ Be affiliated to French social security system.