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
ISRCTN Number
ISRCTN13564930
Research summary
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.Summary of Results:
Plain English Summary
What was the purpose of this study?
This study tested a new experimental COVID 19 vaccine called NeomiVac. The main aim was to find out whether NeomiVac is safe and acceptable when given as a single injection to healthy adults. The study also looked at how the immune system responded to the vaccine.
Why was this study carried out?
COVID 19 continues to change over time, with new variants appearing. Some newer vaccines are being developed to target these variants more specifically. NeomiVac is an mRNA vaccine designed to target the Omicron variant of SARS CoV 2.
Before any new vaccine can be tested in large numbers of people, early phase studies are needed to understand safety and side effects.
Who took part?
• 36 healthy adults aged between 18 and 64 years took part in the study.
• All participants lived in the UK.
• All had previously received COVID 19 vaccines.
• Around three quarters of participants had previously had COVID 19.
• Everyone who enrolled completed the full study follow up.
What happened during the study?
This was an early stage (Phase 1) study carried out at one research centre in Oxford, UK.
Each participant received one injection of NeomiVac into a muscle. Different dose levels were tested to help understand safety at increasing amounts:
• 25 micrograms
• 50 micrograms
• 100 micrograms
Participants were followed for around six months. During this time, researchers:
• Asked participants about side effects
• Checked their general health
• Took blood samples to monitor safety and immune responsesWhat were the main findings?
Side effects and safety
• Most side effects were mild or moderate and did not last long.
• The most common side effect was pain where the injection was given, especially at higher doses.
• Some participants reported headache, tiredness, muscle aches, or feeling feverish for a short time.
• No severe allergic reactions linked to the vaccine occurred.
• No participants died during the study.
Blood test findings
• Some participants had temporary changes in blood test results, such as small changes in red or white blood cells.
• Most changes were mild, caused no symptoms, and returned to normal without treatment.
• One participant had a temporary low potassium level, which resolved and was not thought to be related to the vaccine.
• Mild changes in liver blood tests were seen in a small number of participants and were not considered clinically serious.
What do these results mean?
In this small early stage study, NeomiVac was generally safe and tolerated at all doses tested. The types of side effects seen were similar to those reported with other mRNA COVID 19 vaccines.
This study was not designed to show whether the vaccine prevents COVID 19, and it was too small to identify rare side effects. Larger studies would be needed to answer these questions.
What happens next?
The results from this study may help researchers decide whether further studies of NeomiVac should be carried out. Future research would involve more participants and could look at safety in a wider range of people, as well as how well the vaccine works.
Compliance Statement
This lay summary has been prepared in accordance with Health Research Authority guidance on plain English summaries and is intended for a non specialist public audience. It provides a balanced and accurate overview of the study purpose, conduct and findings, without overstating benefits or implications.REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0136
Date of REC Opinion
19 Apr 2024
REC opinion
Favourable Opinion