Condition: Healthy · Sponsor: ANRS, Emerging Infectious Diseases
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.
This description comes directly from the study's public registry record.
Alizée PERROT · 0033153948074 · cdp.clinique@anrs.fr
Yoann DESVIGNES · 0033247474632 · cpcq@chu-tours.fr
Always discuss trial participation with your own doctor first.
| CHU Dijon Bourgogne - Centre d'Investigation Clinique 1432 | Dijon, France | Not Yet Recruiting |
| HCL - Hôpital de la Croix-Rousse - Service des Maladies Infectieuses et Tropicales | Lyon, France | Not Yet Recruiting |
| APHP - Hôpital Cochin - Centre d'Investigation Clinique de Vaccinologie Cochin-Pasteur 1417 | Paris, France | Not Yet Recruiting |
| CHU de Saint-Etienne - Service des Maladies Infectieuses | Saint-Priest-en-Jarez, France | Not Yet Recruiting |
| CHRU de Tours - Centre d'Investigation Clinique 1415 | Tours, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06821126