New mRNA vaccine against COVID-19 (NeomiVac001)
What is the purpose of this trial?
We need to develop new technologies to achieve rapid clinical development of safe and effective 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 this technology can be used on newer variants of COVID-19 and/or different diseases. This could rapidly accelerate the development of new vaccines against future pandemics and greatly reduce the time taken for new mRNA vaccines to reach patients. There is also potential for this technology to produce vaccines that tackle infections that cannot be treated with current antibiotics due to antibacterial resistance. This could transform the ability to treat bacterial infections globally and save millions of lives.
Whilst NeomiVac is frozen and stored at -80 °C, preliminary data show it may have the potential to be stable for longer at fridge temperature compared with existing mRNA vaccines. If the long-term stability at fridge temperature is confirmed, it would greatly reduce cost, and simplify distribution of mRNA vaccines globally, specifically in low- and middle income countries, where there may be limited facilities and infrastructure available.
The purpose of this study is to test NeomiVac for the first time in healthy volunteers aged 18 64 years. 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.
Am I eligible to participate?
Full eligibility details are contained in the Participant Information Sheet.
What does the trial involve?
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Participant Info Sheet |
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Pre-Screening Questionnaire |
https://app.onlinesurveys.jisc.ac.uk/s/oxford/neomivac001-duplicate |
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Who can take part? |
Healthy adult volunteers aged 18-64 |
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Vaccine being tested |
A single dose of NeomiVac, a new mRNA vaccine at either: a low, medium, or higher dose |
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Total participants |
36 participants |
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Study Aims |
To test safety and immune responses to this vaccine |
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Trial Site |
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital, Oxford, OX3 7LE |
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Reimbursement: |
Up to £975 |
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Risks of participation: |
Symptoms after vaccination such as arm pain and fever may occur and resolve within a few days. A full discussion of risks, including potential rare but serious reactions is contained in the trial information sheet. |
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Benefits of participation: |
Participating in this trial will help our research into the rapid development of a safe and effective vaccines against COVID-19 emerging variants and other infectious diseases. |
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Investigator |
Dr Paola Cicconi (Chief Investigator) |
FAQs
Is there any reimbursement for the trial?
Yes, you will be reimbursed at set rates for your time and inconvenience for all visits attended up to £975.
What happens if I sign up but don’t want to carry on with the study?
Participation is voluntary and you are free to change your mind and withdraw at any time.
What’s next?
Please ensure you read the full Participant Information Sheet.
**Screening is currently paused for this study**
If you are interested in taking part, please click here to apply via the pre-screening questionnaire
If you have any other questions about participating then don’t hesitate to contact the trial team by email at vaccinetrials@ndm.ox.ac.uk