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Study comparing intranasal COVID-19 vaccine (LVT-001) with mRNA vaccine (bretovameran) as booster doses in healthy adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial investigates two different types of COVID-19 vaccines as booster doses in healthy adults. The study compares a new intranasal vaccine called LVT-001, which is given as a nasal spray, with Comirnaty JN.1, which is an injectable mRNA vaccine. The intranasal vaccine contains proteins from the virus that causes COVID-19, while Comirnaty JN.1 contains genetic material that helps the body produce protective proteins.

The main purpose of this study is to evaluate the safety of different doses of the intranasal vaccine and compare how well both vaccines stimulate immune responses in the nose and bloodstream. The study is divided into two parts. In the first phase, researchers will test three different strengths of the nasal vaccine. In the second phase, they will compare the nasal vaccine to the injectable mRNA vaccine.

During the study, participants will receive one booster dose of either the nasal or injectable vaccine. They will be monitored for any side effects and will provide nose swabs and blood samples to measure their immune response. The monitoring period will continue for one year after vaccination. Researchers will also track whether participants develop SARS-CoV-2 infections during this time.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial vaccination visit

    You will receive either an intranasal COVID-19 vaccine (LVT-001) or an intramuscular COVID-19 mRNA vaccine.

    After vaccination, you will need to stay at the clinical site for observation for 1.5 hours.

    The intranasal vaccine may be given in one of three doses: 20, 60, or 120 micrograms.

    You will be asked to follow protective measures (hand washing and mask wearing) from this day until day 28.

  2. Step 2

    First week monitoring

    You will need to record any injection site reactions for 7 days.

    You will need to record any general health changes for 14 days.

    A nose swab sample will be collected on day 7 to measure immune response.

  3. Step 3

    Follow-up visits

    You will need to attend visits on day 14 and day 28 for nose swab samples and blood tests.

    Additional follow-up visits will occur at 3 months, 6 months, and 12 months after vaccination.

    Each visit will include collection of nose swabs and blood samples to measure immune response.

  4. Step 4

    Ongoing monitoring

    Any unexpected health changes should be reported for 28 days after vaccination.

    If you develop COVID-19 symptoms, you will need to get tested with a PCR or antigen test.

    The total duration of participation is 12 months.

    You must not donate blood, plasma, or other bodily fluids for 1 year after vaccination if you receive the LVT-001 vaccine.

Who can join the trial?

13 criteria

  • Must provide written informed consent to participate in the study
  • Must be willing and available to follow all study requirements
  • For women who can become pregnant: must not be pregnant and use highly effective contraception throughout the study
  • Must agree not to donate blood, plasma, or other body fluids for 1 year after vaccination
  • Must stay in the area near the study site for the entire study duration
  • Must follow protective measures against COVID-19 (hand washing and mask wearing) between day 0 and day 28
  • Must agree to be registered in the Health Ministry database
  • Must have French social security coverage
  • Must be between 18-55 years old for Phase I or 18-60 years old for Phase II
  • Must be in good general health, as determined by the study doctor
  • Must have a Body Mass Index (BMI) between 18.5 and 30 kg/m² (a measurement of body fat based on height and weight)
  • Must have received either:
    • At least 3 doses of COVID-19 mRNA vaccine, with the last dose given at least 6 months before the study, OR
    • 2 doses of COVID-19 mRNA vaccine plus a confirmed COVID-19 infection at least 6 months before joining the study

Who cannot join the trial?

15 criteria

  • History of severe allergic reactions or anaphylaxis to any vaccine components
  • Pregnancy or breastfeeding
  • Active COVID-19 infection or positive test within the last 30 days
  • Participation in another clinical trial within the past 3 months
  • Any chronic medical condition that is not well-controlled
  • History of immunodeficiency disorders (conditions that weaken the immune system)
  • Use of medications that suppress the immune system
  • Bleeding disorders or use of blood thinners
  • Previous severe reaction to any COVID-19 vaccine
  • Nasal conditions that could interfere with intranasal vaccine administration
  • Fever or acute illness within 7 days before vaccination
  • History of neurological conditions (disorders affecting the brain and nervous system)
  • Active respiratory infection or significant nasal symptoms
  • Receipt of any other vaccine within 14 days before study participation
  • History of drug or alcohol abuse within the past year
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Investigated drugs

  • LVT-001

    is an intranasal vaccine for COVID-19 that contains SARS-CoV-2 N/S recombinant proteins. This vaccine is administered as a nasal spray, aiming to provide protection against COVID-19 by stimulating immune responses in the nasal passages, which is where the virus typically enters the body.

  • Pfizer-BioNTech COVID-19 vaccine

    is an mRNA vaccine that is injected into the muscle of the upper arm. This vaccine teaches the body's cells to make harmless pieces of the virus that causes COVID-19, helping the immune system learn to recognize and fight the virus.

What is already known about the treatment

  • LVT-001

    An investigational intranasal COVID-19 vaccine that expresses SARS-CoV-2 N/S recombinant proteins, administered as a nasal spray. This vaccine is currently being studied in Phase I/II clinical trials as a potential booster dose option, with testing of three different dosage levels (20 µg, 60 µg, and 120 µg). The vaccine aims to generate mucosal immune response in the nasal passages, which may provide additional protection against COVID-19 infection compared to traditional intramuscular vaccines. It represents a novel approach to COVID-19 vaccination by targeting the initial site of viral entry.

  • Pfizer-BioNTech COVID-19 Vaccine

    An intramuscular mRNA vaccine that instructs cells to produce copies of the SARS-CoV-2 spike protein, triggering an immune response. This vaccine has received widespread authorization for use globally and serves as the comparison vaccine in this clinical trial. It works by delivering genetic instructions to cells through lipid nanoparticles, prompting the body to create antibodies and T-cells against the coronavirus, and has been extensively studied in large-scale clinical trials demonstrating its safety and efficacy.

Investigated diseases

COVID-19 - A respiratory illness caused by the SARS-CoV-2 virus that primarily affects the lungs and respiratory system. The virus can spread through respiratory droplets when an infected person coughs, sneezes, or talks. Symptoms typically develop within 2-14 days after exposure and can range from mild to severe, including fever, cough, fatigue, loss of taste or smell, and breathing difficulties. The infection can affect multiple organ systems in the body, including the respiratory, cardiovascular, and nervous systems. Some people may experience long-term effects even after the initial infection has cleared. Note: Since the trial data mentions "Healthy volunteers" as the medical condition, COVID-19 is included as the relevant disease because the study focuses on COVID-19 vaccination, though the participants themselves are healthy.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-510589-17-00Protocol codeDR230330 – ANRS0514sEstimated enrolment238 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

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