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HealthyPhase 1/2MUCOBOOSTNCT06821126

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

A Phase 1/2 study testing LVT-001 and Cormirnaty in people with Healthy, run by ANRS, Emerging Infectious Diseases at 5 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LVT-001 and Cormirnaty
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
5 sitesFrance
Study dates
9 May 2025to Mar 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 ˂30 kg/m².
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.
  • Previous nasal surgery or nasal cauterization.
  • History of frequent epistaxis.
Show all 28Show fewer
  • Virologically documented (PCR or antigenic test) history of COVID-19 in the past 6 months.
  • Positive COVID-19 PCR test at screening visit.
  • Medical problems due to alcohol.
  • Illicit drug use within the past 12 months.
  • 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.
  • Received influenza vaccination within 14 days prior to trial vaccination, or any other licensed vaccine within 4 weeks prior to study vaccination.
  • Vaccination with a COVID-19 vaccine other than mRNA vaccine.
  • Known sensitivity to any of the ingredients of the trial vaccines.
  • Known allergic reaction to plastic.
  • Positive serology for hepatitis B (HBsAg), C (anti-HCV antibodies) and HIV 1-2.
  • History of severe adverse events following vaccine administration including anaphylactic reaction and associated symptoms such as rash, breathing problems, angioedema, and abdominal pain, or a history of allergic reaction that could be triggered by a component of the SARS-CoV-2 vaccine at the time of the first vaccine administration.
  • Pregnancy positive test (βHCG test) or pregnancy or breastfeeding.
  • Received immunoglobulin or other blood products within three months prior to inclusion or planned administration before the trial completion.
  • Received an immunosuppressive therapy for underlying disease or a treatment with immunosuppressive or cytotoxic drugs or a cancer chemotherapy or radiation therapy within the previous 36 months.
  • Received drugs such as corticosteroids at a dosage > 10 mg prednisone equivalent/day or inhalers corticosteroids, within 3 months prior to inclusion (excluding corticosteroid topical preparations for cutaneous application).
  • Abnormal and deemed clinically significant result by the investigator following the routine analyzes carried out at the time of the screening visit (any grade 4 biological result, even if deemed not clinically significant by the investigator, constitutes an exclusion criterion).
  • History of severe psychiatric disorders that may affect participation in the trial.
  • Any other serious chronic illness requiring immediate monitoring by a hospital specialist.
  • Any other condition that, in the opinion of the investigator, would compromise the safety or rights of a volunteer participating in the trial or render the subject unable to comply with the protocol.
  • Phase II only: Participants included in phase I will not be included in phase II.
  • Participants under legal protection (e.g., guardianship, tutorship).

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alizée PERROT contact

0033153948074

cdp.clinique@anrs.fr

Yoann DESVIGNES contact

0033247474632

cpcq@chu-tours.fr

5 sites in 1 country

France5 sites, 5 recruiting

  • CHU Dijon Bourgogne - Centre d'Investigation Clinique 1432

    Dijon, 21079

    Ines BEN GHEZALA, Dr., +33380281453, ines.ben-ghezala@chu-dijon.fr

    Not yet recruiting

  • HCL - Hôpital de la Croix-Rousse - Service des Maladies Infectieuses et Tropicales

    Lyon, 69004

    Anne CONRAD, Dr., +33472071107, anne.conrad@chu-lyon.fr

    Not yet recruiting

  • APHP - Hôpital Cochin - Centre d'Investigation Clinique de Vaccinologie Cochin-Pasteur 1417

    Paris, 75679

    Odile LAUNAY, Prof., +33158412860, odile.launay@aphp.fr

    Not yet recruiting

  • CHU de Saint-Etienne - Service des Maladies Infectieuses

    Saint-Priest-en-Jarez, 42270

    Elisabeth BOTELHO NEVERS, Prof., +33477829234, elisabeth.botelho-nevers@chu-st-etienne.fr

    Not yet recruiting

  • CHRU de Tours - Centre d'Investigation Clinique 1415

    Tours, 37044

    Zoha MAAKAROUN-VERMESSE, Dr., +33247476972, z.maakaroun-vermesse@chu-tours.fr

    Recruiting

Other trials in France

About this study

Official title: 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.

Read more

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.

Read the detailed description

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:

  • Cohort A (12 participants): 20 µg
  • Cohort B (12 participants): 60 µg
  • Cohort C (12 participants): 120 µg

Phase II: Two investigational medicinal products will be compared:

  • The selected dose of the intranasal recombinant protein vaccine LVT-001, administered at Day 0 in each nostril.
  • The intramuscular COVID-19 mRNA vaccine (Pfizer-BioNTech), administered as the standard of care booster.

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.

Conditions
Healthy
Being tested
LVT-001, Cormirnaty
Keywords
COVID-19, Healthy, Nasal, vaccine, intranasal
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LVT-001Biological

    Intranasal administration

  • CormirnatyBiological

    Intramuscular administration

Study groups in NCT06821126
Study groupRoleWhat they receive
LVT-001ExperimentalOne 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
Receives: Biological: LVT-001
ComirnatyActive comparatorOne booster dose of the intramuscular COVID-19 mRNA vaccine (Pfizer-BioNTech - recommended at the beginning of the Phase II in France) at Day 0.
Receives: Biological: Cormirnaty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Proportion of participants experiencing an immediate adverse event

    Measured: Within an hour and half following the vaccination at Day 0

  2. 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"

    Measured: Between Day 0 and Day 7 (Day 0 is the day of the vaccination)

  3. 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"

    Measured: Between Day 0 and Day 14 (Day 0 is the day of the vaccination)

  4. Phase I: Proportion of participants experiencing an unsolicited adverse events

    Unsolisited adverse events (AEs) are AEs other than solicited AEs

    Measured: Between Day 0 and Day 28 (Day 0 is the day of the vaccination)

  5. 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

    Measured: Between Day 0 to Month 12 (Day 0 is the day of the vaccination)

  6. 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

    Measured: Between Day 0 and Day 28 (Day 0 is the day of the vaccination)

Secondary outcomes (13)

  1. Crude variation of the mucosal humoral immune response specific to the vaccine N/S recombinant protein

    sIgA from nose swabs measured by ELISA

    Measured: 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)

  2. 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

    Measured: 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)

  3. 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

    Measured: 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)

  4. 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

    Measured: 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)

  5. 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)

    Measured: 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)

  6. Proportion of participants with COVID-19 infections confirmed by a positive PCR test or a positive antigen test in each arm

    Measured: Between Day 0 and Month 12 (Day 0 is the day of the vaccination)

  7. Description of variant types identified on participants with a positive PCR test

    Measured: In case of positive PCR test between the vaccination on Day 0 and Month 12

  8. Proportion of participants with serious COVID-19 infections defined as a hospitalization and/or death due to the COVID-19

    Measured: Between Day 0 and Month 12 in each arm (Day 0 is the day of the vaccination)

  9. Phase II: Proportion of participants experiencing an immediate AE

    Measured: Within one hour following the vaccination at Day 0

  10. 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"

    Measured: Between Day 0 and Day 7 (Day 0 is the day of the vaccination)

  11. 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"

    Measured: Between Day 0 and Day 14 (Day 0 is the day of the vaccination)

  12. Phase II: Proportion of participants experiencing an unsolicited adverse events

    Unsolisited adverse events (AEs) are AEs other than solicited AEs

    Measured: Between Day 0 and Day 28 (Day 0 is the day of the vaccination)

  13. 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

    Measured: Between Day 0 and Month 12 (Day 0 is the day of the vaccination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2025
  2. Study start9 May 2025
  3. Primary completionOct 2026 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase I : Dose escalation Phase II : open label, superiority, controlled, randomized
Masking
None (open label)
Enrolment
238 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06821126
Sponsor's protocol ID
DR230330 - ANRS0514s MUCOBOOST
Other IDs
2024-510589-17-00
Acronym
MUCOBOOST
Status last verified
Dec 2025
First submitted
28 Jan 2025
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LVT-001 and Cormirnaty in people with Healthy, run by ANRS, Emerging Infectious Diseases at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alizée PERROT (0033153948074, cdp.clinique@anrs.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Proportion of participants experiencing an immediate adverse event (time frame: Within an hour and half following the vaccination at Day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06821126.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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