ISRCTN13564930进行中（未招募）1 期
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
eoVac Ltd.0 个研究点目标入组 36 人开始时间: 2024年4月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
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