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.
≥ 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).
Temperature ≥ 38.0°C or symptoms of acute self-limiting illness such as upper respiratory tract infection or gastroenteritis within three days prior to vaccine dose.
Any form of contraindication to the trial vaccines tested.
History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might alter nasal mucosa and affect vaccine response.
A piercing or obstruction in the nostrils that could impede vaccine administration.
Parallel
LVT-001
Biological/VaccineIntranasal administration
Cormirnaty
Biological/VaccineIntramuscular administration
Phase I: Proportion of participants experiencing an immediate adverse event
Phase I: Proportion of participants experiencing solicited local reactogenicity
Vaccines are associated with a number of well-characterised reactions referred to as "solicited adverse events"
Phase I: Proportion of participants experiencing solicited systemic signs and symptoms
Vaccines are associated with a number of well-characterised reactions referred to as "solicited adverse events"
Phase I: Proportion of participants experiencing an unsolicited adverse events
Unsolisited adverse events (AEs) are AEs other than solicited AEs
Crude variation of the mucosal humoral immune response specific to the vaccine N/S recombinant protein
sIgA from nose swabs measured by ELISA
Neutralizing capacity of the mucosal humoral immune response specific to the vaccine N/S recombinant protein
Neutralizing Ig from nose swabs measured by PRNT and VLP assays
Crude variation of the systemic humoral immune response specific to the vaccine N/S recombinant protein
Serum anti-S and anti-N IgG measured by ELISA
Neutralizing capacity of the systemic humoral immune response specific to the vaccine N/S recombinant protein
Neutralizing serum IgG measured by PRNT and VLP assays
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ANRS, Emerging Infectious Diseases
Lead sponsor
University Hospital, Tours (Cosponsor)
Collaborator
UMS 54 MART
Collaborator
INSERM CIC 1415
Collaborator
LovalTech
Collaborator
INSERM U1259 MAVIVHe
Collaborator
BioMAP - UMR ISP 1282 - Tours University - INRAE
Collaborator
Virology unit, University Hospital, Tours
Collaborator
I-REIVAC Innovative Clinical Research Network In Vaccinology
Collaborator
