ISRCTN13726895进行中（未招募）未知
A first-in-person trial of a modified Vaccina Ankara vectored anti-Zika vaccine MVAZIKB administered on two occasions 28 days apart at dose levels of 5x10e7 and 1x10e8 plaque-forming units in healthy adults
niversity of Liverpool0 个研究点目标入组 18 人开始时间: 2022年7月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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
- •Patients eligible for the trial must comply with all of the following at screening. Inclusion criteria as per protocol provided in brackets:
- •1. A male or female adult between 18 and 59 years of age at consent
- •4. No planned re-location or foreign travel during the study period
- •7. If female, negative pregnancy test at the point of screening and dosing
- •8. If female, prepared to use an efficacious method of contraception during the study from screening and until 28 days after the last vaccine dose for women of childbearing potential
排除标准
- •Any patient meeting any of the criteria listed below at baseline will be excluded from study participation. Exclusion criteria as per protocol provided in brackets:
- •1. Use of any investigational or non-registered drug within 5 half-lives of the drug, or 30 days preceding administration of study vaccine, whichever is longer
- •3. Receipt of any biologic agents with mechanisms of action that might affect the immune system, at the discretion of the CI and local PI
- •4. Administration of immunosuppressants or other immune-modifying drugs within a period of six months before vaccination or at any time during the study period; participants who have received these agents may also be excluded at the discretion of the CI and local PI.
- •5. Any confirmed or suspected immunosuppressive or immunodeficient condition.
- •6. A family history of congenital or hereditary immunodeficiency.
- •7. Any antiviral drug therapy within a period of 5 drug half-lives or 30 days before vaccination, whichever is longer,
- •8. History of significant allergic reactions likely to be exacerbated by any component of the study vaccine, especially allergic disease or reactions to any previous dose of any vaccine.
- •9. Any history of anaphylaxis
- •10. Residence of >6 continuous weeks or 3 months in total in any country where Zika or dengue virus infection is plausible or likely.
- •11. History of proven or strongly suspected flavivirus infection.
- •12. Acute disease (for example acute infection) at the time of enrolment or vaccination, if symptoms are rated as anything more significant than a mild adverse event. Entry into the study and/or vaccination may be deferred until the illness has resolved for at least one week.
- •13. Acute or chronic, clinically significant in the opinion of the investigator, disease in any organ system, as determined by history, physical examination or laboratory testing.
- •14. Presence of any inflammatory condition that might require immunomodulatory therapy.
- •15. Recent blood donation (inclusion can be delayed under these circumstances; the participant should be enrolled 16 weeks after their last blood donation. Each participant should give no more than 470 ml per 16 weeks, so regular blood donation should be suspended during the study and can re-commence 1 month after the last study sample).
- •16. Prior receipt of a vaccinia based vaccine at any time
- •17. Administration of immunoglobulins or other blood products containing immunoglobulin within the three months preceding the planned administration of vaccine
- •18. Administration of any other vaccine (e.g. COVID vaccine) within 30 days of vaccination with MVAZIKZB. In this event, screening can by carried out, and dosing can be delayed until 30 days have elapsed.
- •19. Any autoimmune condition except mild dermatological problems including psoriasis, vitiligo, and mild eczema, asthma, hay fever.
- •20. History of allergic disease or reactions to vaccine or egg allergy.
- •21. Any history of angioedema
- •22. History of cancer
- •23. History of serious psychiatric condition likely to affect participation in the study.
- •24. Bleeding disorder or prior history of significant bleeding or bruising following intramuscular injection.
- •25. Extreme body mass index greater than 40KG per metre squared or less than 18 kilogrammes per metre squared
- •26. Suspected or known current alcohol abuse defined by greater than 42 units per week.
- •27. Suspected or known injecting drug use
研究者
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