Table of Contents
- Trial overview
- Who is being studied
- What is being tested
- Trial phases and design
- What outcomes are measured
- What this trial means for patients
Trial overview
NCT06821126 is an interventional study of LVT-001 in healthy adults.[1] It is a randomized, controlled, multicenter Phase 1/2 trial with 238 planned participants.[1] The study is authorised.[1]
The trial compares an intranasal booster dose of LVT-001 with a COVID-19 mRNA booster given by injection into the muscle.[1] The main goal is to study safety and the immune response after vaccination.[1]
Who is being studied
The target population is healthy volunteers, meaning adults without the condition being treated in the study.[1] The brief summary says the trial is in healthy adult volunteers.[1]
No other detailed eligibility rules are given in the source data.[1] 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.[1]
What is being tested
The study tests LVT-001 as an intranasal COVID-19 vaccine booster.[1] “Intranasal” means it is given through the nose.[1]
The trial also compares LVT-001 with Comirnaty JN.1, a COVID-19 mRNA vaccine given by intramuscular injection.[1] This comparison helps researchers see whether the nasal booster gives a stronger response in the nose lining, which is called the mucosa.[1]
In Phase 1, the study evaluates three booster doses of LVT-001: 20 µg, 60 µg, and 120 µg.[1] In Phase 2, it compares the immune response after the nasal booster with the response after the injected mRNA booster.[1]
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.[1] Phase 1 is mainly about safety, while Phase 2 looks at whether the booster creates a better mucosal immune response.[1]
The study is randomized and controlled.[1] Randomized means participants are assigned to study groups by chance, and controlled means the trial includes a comparison group.[1] It is also multicenter, so it is carried out at more than one study site.[1]
What outcomes are measured
The Phase 1 outcomes focus on safety after vaccination.[1] 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.[1]
Reactogenicity means the expected short-term reactions after a vaccine, such as local or body-wide symptoms.[1] The study also tracks serious adverse events, serious adverse reactions, suspected unexpected serious adverse reactions, and adverse events of special interest.[1]
The Phase 2 outcome measures the change in mucosal humoral immune response from day 0 to day 28.[1] This is measured by ELISA using IgA from nose swabs.[1] IgA is a type of antibody, and nose swabs help show how the immune system responds in the nose lining.[1]
What this trial means for patients
This trial is not about treating people who are already sick with COVID-19.[1] It is about testing a booster vaccine approach in healthy adults and learning whether a nasal booster can produce a useful immune response.[1]
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.[1] 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.[1]
