A study of a next generation mRNA-LNP vaccine against SARS-CoV-2
Research type
Research Study
Full title
A Phase I Monotherapy Study to Evaluate the Safety, Tolerability and Immunogenicity of a Candidate Next Generation Lipid Nanoparticle (LNP) mRNA Vaccine Against SARS-CoV-2 (NeomiVac) in UK Healthy Adult Volunteers
IRAS ID
1006703
Contact name
Eran Eilat
Contact email
Sponsor organisation
NeoVac Ltd
Research summary
We need to develop new technologies to achieve rapid clinical development of safe and efficacious vaccines. We are carrying out a clinical trial of a new mRNA vaccine targeting the Omicron BA.1 variant of COVID-19 called NeomiVac. If NeomiVac is shown to be safe and capable of inducing an immune response, then the mRNA molecule in the formulation will be updated to tackle newer variants of concern (as has been done with the Pfizer-BioNTech and Moderna vaccines) and/or different diseases. This could rapidly accelerate the development of new vaccines and greatly reduce the time taken for new mRNA vaccines to reach patients.
The purpose of this study is to test NeomiVac for the first time in healthy volunteers. The trial will give us valuable information on the safety of the vaccine and the immune response it creates in healthy volunteers and will involve giving participants one dose of the vaccine and then following them up over 6 months.
We plan to recruit 36 people aged between 18-64 in good health. We will be testing three different doses of the vaccine: low, medium and higher dose.
We will vaccinate individuals in the low dose group first and review them for safety before starting any of the medium dose group vaccinations. Likewise, the medium dose participants will be vaccinated and reviewed for safety before we start vaccinating the higher dose group.
After pre-vaccination (screening) and vaccination visits, all participants will return to the clinic for 6 follow up visits over 6 months. They will be assessed at each visit for safety and to take blood tests to measure their immune responses.
The study is sponsored and funded by NeoVac Ltd. It is being carried out by Oxford University researchers based at the Clinical Trial Unit of the Jenner Institute, the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford.REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0375
Date of REC Opinion
29 Jan 2024
REC opinion
Further Information Unfavourable Opinion