In short
Clinical trials are investigating LVT-001 as an intranasal COVID-19 vaccine booster in healthy adults. These studies aim to assess safety and immune response, and to compare it with an intramuscular mRNA COVID-19 booster. The trial is in Phase 1/2 and includes healthy volunteers.
Key points
- LVT-001 is being studied in a Phase 1/2 clinical trial in healthy adult volunteers. The trial tests LVT-001 as an intranasal COVID-19 booster and compares it with an intramuscular mRNA booster. Researchers are mainly looking at safety in Phase 1 and immune response in Phase 2. Safety outcomes include immediate and later side effects, serious adverse events, and other important safety events. The immune outcome focuses on mucosal humoral response, measured with IgA from nose swabs. The trial is authorised and includes 238 participants.
Trial overview
NCT06821126 is an interventional study of LVT-001 in healthy adults. It is a randomized, controlled, multicenter Phase 1/2 trial with 238 planned participants. The study is authorised.
The trial compares an intranasal booster dose of LVT-001 with a COVID-19 mRNA booster given by injection into the muscle. The main goal is to study safety and the immune response after vaccination.
Who is being studied
The target population is healthy volunteers, meaning adults without the condition being treated in the study. The brief summary says the trial is in healthy adult volunteers.
No other detailed eligibility rules are given in the source data. Based on the available information, the study is focused on people who can safely join a vaccine booster trial and help researchers compare two booster approaches.
What is being tested
The study tests LVT-001 as an intranasal COVID-19 vaccine booster. “Intranasal” means it is given through the nose.
The trial also compares LVT-001 with Comirnaty JN.1, a COVID-19 mRNA vaccine given by intramuscular injection. This comparison helps researchers see whether the nasal booster gives a stronger response in the nose lining, which is called the mucosa.
In Phase 1, the study evaluates three booster doses of LVT-001: 20 µg, 60 µg, and 120 µg. In Phase 2, it compares the immune response after the nasal booster with the response after the injected mRNA booster.
Trial phases and design
This is a Phase 1/2 study, which means it combines early safety testing with a more detailed look at immune response. Phase 1 is mainly about safety, while Phase 2 looks at whether the booster creates a better mucosal immune response.
The study is randomized and controlled. Randomized means participants are assigned to study groups by chance, and controlled means the trial includes a comparison group. It is also multicenter, so it is carried out at more than one study site.
What outcomes are measured
The Phase 1 outcomes focus on safety after vaccination. Researchers measure immediate adverse events within 1.5 hours, solicited local reactogenicity and systemic signs and symptoms over 7 to 14 days, unsolicited adverse events up to 28 days, and serious safety events throughout the trial.
Reactogenicity means the expected short-term reactions after a vaccine, such as local or body-wide symptoms. The study also tracks serious adverse events, serious adverse reactions, suspected unexpected serious adverse reactions, and adverse events of special interest.
The Phase 2 outcome measures the change in mucosal humoral immune response from day 0 to day 28. This is measured by ELISA using IgA from nose swabs. IgA is a type of antibody, and nose swabs help show how the immune system responds in the nose lining.
What this trial means for patients
This trial is not about treating people who are already sick with COVID-19. It is about testing a booster vaccine approach in healthy adults and learning whether a nasal booster can produce a useful immune response.
The study may help answer two important questions: first, whether LVT-001 is safe enough to keep studying, and second, whether it may work better than a standard injected booster for immune protection in the nose. Because the trial is still in Phase 1/2, it is an early step in research and is mainly designed to gather safety and immune-response data.