A Phase 1/2 interventional study of LVT-001 and Cormirnaty in Healthy, sponsored by ANRS, Emerging Infectious Diseases. Recruiting at 5 sites in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 1/2, Interventional, and Prevention
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 is a randomized, comparative, multicenter, open-label, phase I/II trial in France evaluating the 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.
Phase I dose escalating - Primary Objective: To evaluate the safety of three escalating doses of a boost of an intranasal COVID-19 vaccine (LVT-001) expressing SARS-CoV-2 N/S recombinant protein in healthy volunteers.
Phase II superiority trial - Primary Objective: To evaluate, using nasal swabs, the superiority of a booster dose of the selected intranasal COVID-19 vaccine (LVT-001) expressing SARS-COV-2 N/S recombinant protein versus a booster dose of the intramuscular COVID-19 mRNA vaccine (Pfizer-BioNTech) in healthy adult volunteers in term of mucosal humoral immune response at Day 28.
Trial population: A total of 36 and 202 healthy volunteers will be enrolled in Phase I and Phase II, respectively.
Interventions:
Phase I: The investigational medicinal product is the intranasal recombinant protein vaccine LVT-001 administered at Day 0 in each nostril:
Phase II: Two investigational medicinal products will be compared:
Expected Outcomes and Safety Considerations:
In Phase I, healthy participants are not expected to benefit directly from the trial aside from the potential theoretical benefit of a mucosal immune response against SARS-CoV-2. Currently, no clinical trial data exist for a nasal protein vaccine in humans.
The anticipated risks primarily include local nasal reactions and systemic reactions similar to those observed with other vaccines. Any adverse events following vaccination are expected to be manageable with routine care, as determined by investigators.
Given that this is the first human trial of a nasal protein vaccine, the dose-escalation design ensures a safety margin, allowing for careful monitoring before progressing to the next cohort.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 238 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Be male or female between the ages of:
Exclusion Criteria:
Participation in another trial within 60 days prior to the enrolment visit or planned participation during the present trial period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
Note: Participation in an observational study is allowed.
One booster dose of the intranasal vaccine LVT-001 administered as a nasal spray in each nostril at Day 0. Phase I - 3 cohortes with dose escalation (low, middle and high doses) Phase II - 1 arm at the selected dose
Biological: LVT-001
One booster dose of the intramuscular COVID-19 mRNA vaccine (Pfizer-BioNTech - recommended at the beginning of the Phase II in France) at Day 0.
Biological: Cormirnaty
Intranasal administration
Intramuscular administration
Phase I: Proportion of participants experiencing an immediate adverse event
Time frame: Within an hour and half following the vaccination at Day 0
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"
Time frame: Between Day 0 and Day 7 (Day 0 is the day of the vaccination)
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"
Time frame: Between Day 0 and Day 14 (Day 0 is the day of the vaccination)
Phase I: Proportion of participants experiencing an unsolicited adverse events
Unsolisited adverse events (AEs) are AEs other than solicited AEs
Time frame: Between Day 0 and Day 28 (Day 0 is the day of the vaccination)
Phase I: Proportion of participants experiencing serious adverse events (SAEs), serious adverse reactions (SARs), suspected unexpected serious adverse reactions (SUSARs) and adverse events of special interest (AESI) respectively throughout the study
Time frame: Between Day 0 to Month 12 (Day 0 is the day of the vaccination)
Phase II: Crude variation of the mucosal humoral immune response specific to the vaccine N/S recombinant protein in each arm
sIgA from nose swabs measured by ELISA
Time frame: Between Day 0 and Day 28 (Day 0 is the day of the vaccination)
Crude variation of the mucosal humoral immune response specific to the vaccine N/S recombinant protein
sIgA from nose swabs measured by ELISA
Time frame: Between Day 0 and Day 7 (Phase I), Day 14, D28 (Phase I), Month 3, Month 6 and Month 12 (Day 0 is the day of the vaccination)
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
Time frame: At Day 0, Day 7 (Phase I), Day 14, Day 28, Month 3, Month 6, Month 12 (Day 0 is the day of the vaccination)
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
Time frame: At Day 0, Day 7 (Phase I), Day 14, Day 28, Month 3, Month 6, Month 12 (Day 0 is the day of the vaccination)
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
Time frame: at Day 0, Day 7 (Phase I), Day 14, Day 28, Month 3, Month 6, Month 12 (Day 0 is the day of the vaccination)
Percentage of responder against N and S antigens
Quantification of IFN-gamma specifically secreted by T lymphocytes following exposure to antigens N and S measured by ELISpot SARS-CoV-2 assay (subset of participants recruited only in the Tours site for feasibility reason - Phase I: 6 participants in each dose group. Phase II: 40 participants)
Time frame: at Day 0, Day 7 (Phase I), Day 14, Day 28, Month 3, Month 6, Month 12 (Day 0 is the day of the vaccination)
Proportion of participants with COVID-19 infections confirmed by a positive PCR test or a positive antigen test in each arm
Time frame: Between Day 0 and Month 12 (Day 0 is the day of the vaccination)
Description of variant types identified on participants with a positive PCR test
Time frame: In case of positive PCR test between the vaccination on Day 0 and Month 12
Proportion of participants with serious COVID-19 infections defined as a hospitalization and/or death due to the COVID-19
Time frame: Between Day 0 and Month 12 in each arm (Day 0 is the day of the vaccination)
Phase II: Proportion of participants experiencing an immediate AE
Time frame: Within one hour following the vaccination at Day 0
Phase II: Proportion of participants experiencing solicited local reactogenicity
Vaccines are associated with a number of well-characterised reactions referred to as "solicited adverse events"
Time frame: Between Day 0 and Day 7 (Day 0 is the day of the vaccination)
Phase II: 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"
Time frame: Between Day 0 and Day 14 (Day 0 is the day of the vaccination)
Phase II: Proportion of participants experiencing an unsolicited adverse events
Unsolisited adverse events (AEs) are AEs other than solicited AEs
Time frame: Between Day 0 and Day 28 (Day 0 is the day of the vaccination)
Phase II: Proportion of participants experiencing serious adverse events (SAEs), serious adverse reactions (SARs), suspected unexpected serious adverse reactions (SUSARs) and adverse events of special interest (AESI) respectively throughout the study
Time frame: Between Day 0 and Month 12 (Day 0 is the day of the vaccination)
Plan to share: Undecided
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ANRS, Emerging Infectious Diseases