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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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6 May 2024 |
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Main ID: |
ISRCTN13564930 |
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Date of registration:
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23/04/2024 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A study of a next generation mRNA-LNP vaccine against SARS-CoV-2
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Scientific title:
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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 |
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Date of first enrolment:
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15/05/2024 |
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Target sample size:
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36 |
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Recruitment status: |
Ongoing |
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URL:
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https://www.isrctn.com/ISRCTN13564930 |
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Study type:
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Interventional |
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Study design:
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Interventional non randomized (Safety)
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Phase:
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Phase I
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Countries of recruitment
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England
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United Kingdom
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Contacts
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Name:
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NeoVac Clinical Trial Department
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Address:
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NeoVac Ltd, Atlas Building, Fermi Avenue, Harwell Campus
OX11 0QX
Didcot
United Kingdom |
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Telephone:
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+44 7791011763 |
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Email:
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clinicaltrials@neovac.co.uk |
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Affiliation:
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Healthy adults aged 18 to 64 years.
2. Able and willing (in the Investigator’s opinion) to comply with all study requirements.
3. Willing to allow confirmation of their past medical history either through provision of a GP medical record summary, allowing investigators to obtain a copy of their medical history from their GP practice or by providing an alternative acceptable means of confirming their past medical history.
4. Agreement to refrain from blood donation during the course of the study.
5. Provide written informed consent.
6. For women of childbearing potential only: Willingness to practice continuous effective contraception for the duration of the trial.
7. For women of childbearing potential only: A negative pregnancy test on the day of both screening and vaccination.
8. Considered healthy with no current conditions that may significantly impair participant safety or influence study results, in the opinion of the Investigator.
Exclusion criteria: 1. A history of COVID-19 infection (confirmed either by lateral flow test or PCR) within 30 days of the study vaccination.
2. Participation in another research study involving receipt of an investigational product in the 90 days preceding enrolment or during the trial follow up period.
3. Receipt of any COVID vaccine during the 3 months prior to screening and planned receipt of another COVID vaccine for 3 months after receiving the trial vaccine.
4. Planned or actual receipt of any non-COVID vaccines administered within 14 days (before or after) enrolment EXCEPT for live vaccines, which must not be given within 30 days of the trial vaccine.
5. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
6. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) systemically active immunosuppressant medication within the past 6 months.
7. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
8. History of allergy to polyethylene glycol (PEG)
9. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
10. History of anaphylaxis in relation to vaccination.
11. History of myocarditis, pericarditis, or any active known heart disease.
12. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
13. History of serious psychiatric condition likely to affect participation in the study.
14. Ongoing or planned pregnancy or breastfeeding during the trial follow up period.
15. Bleeding disorder (e.g. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
16. Detectable circulating hepatitis B surface antigen (HBsAg).
17. Seropositive for hepatitis C virus (antibodies to HCV).
18. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis.
19. Participant has any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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COVID-19
Infections and Infestations
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Intervention(s)
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A total of 36 participants will take part in this open-label study. Each participant will be allocated to one of 3 treatment Cohorts in a sequential manner. All participants will receive a dose of NeomiVac and there is no placebo cohort.
Cohort 1: The first 6 eligible participants will receive a single low dose of NeomiVac (25 micrograms).
Cohort 2: The next 15 eligible participants will receive a single medium dose of NeomiVac (50 micrograms)
Cohort 3: The final 15 eligible participants will receive a single high dose of NeomiVac (100 micrograms).
All vaccinations will be administered via intramuscular injection. There will be safety reviews after the first and third participant in each cohort is vaccinated to confirm it is safe to vaccinate the remainder of the cohort at the tested dose. There will also be safety reviews 7 days after the last participant from each cohort is vaccinated before proceeding to the next cohort with a higher dose.
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Primary Outcome(s)
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Incidence of safety and reactogenicity events for approximately 6 months following the vaccination:
1. Adverse events and/or adverse events leading to study discontinuation
2. Serious adverse events
3. Grade =3 local and systemic reactions
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Secondary Outcome(s)
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1. Binding IgG antibody levels to S protein to the Omicron variant and relevant subvariants and to Wuhan at baseline, D14, D28, D56 and D182
2. Neutralising antibody levels to Omicron and Wuhan live virus (variants and relevant subvariants) at baseline, D14,D28, D56 and D182
3. Antigen-specific T cell responses to S antigen by IFN-gamma ELISPOT assays at baseline and at D14, D28, D56 and D182
4. Incidence of Grade =1 abnormalities in LFTs (ALT/AST/GGT) at baseline and at D3, D7, D14, D28, D56 and D182 timepoints
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Secondary ID(s)
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NeomiVac001, IRAS 1006703
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Nil known
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Source(s) of Monetary Support
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NeoVac Ltd.
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Ethics review
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Status: Approved
Approval date: 19/04/2024
Contact:
oxforda.rec@hra.nhs.uk
South Central – Oxford A Research Ethics Committee; ref: 24/SC/0136
+44 207 104 8272
oxforda.rec@hra.nhs.uk
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2025 |
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URL:
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