ISRCTN14935155进行中（未招募）1 期
A phase I study to assess the safety and immunogenicity of an MVA-based vaccine for Crimean-Congo Haemorrhagic Fever (MVA-CCHF)
niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 18 人开始时间: 2021年11月10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
- 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
- •1. Healthy adults aged 18 to 45 years
- •2. Able and willing (in the Investigator’s opinion) to comply with all study requirements
- •3. Willing to allow the Investigators to discuss the volunteer’s medical history with their General Practitioner (GP)
- •4. Willingness to practice continuous effective contraception (see below) during the study and (for females only) a negative pregnancy test on the day(s) of screening and vaccination
- •5. Agreement to refrain from blood donation during the course of the study
- •6. Provide written informed consent
- •7. Female volunteers of childbearing potential are required to use an effective form of contraception for the duration of their participation in the study. Acceptable forms of contraception for female volunteers are as follows:
- •7.1.Established use of oral, injected or implanted hormonal methods of contraception
- •7.2. Placement of an intrauterine device or intrauterine system
- •7.3. Total abdominal hysterectomy or surgical sterilisation
- •7.4. Barrier methods of contraception (condom or occlusive cap with spermicide)
- •7.5. Male sterilisation if the vasectomised partner is the sole partner for the subject
- •7.6. True abstinence when this is in line with the preferred and usual lifestyle of the subject
排除标准
- •Current exclusion criteria as of 06/04/2023:
- •1. Participation in another research study involving receipt of an investigational product in the 30 days preceding receipt of MVA-CCHF, or planned use during the study period
- •2. Prior receipt of an MVA based vaccine or other investigational vaccine likely to impact on interpretation of the trial data, as assessed by the investigator
- •3. Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe
- •4. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- •5. Confirmed or under investigation for immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 20 mg/day (for adult subjects), or equivalent. Inhaled and topical steroids are allowed
- •6. Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab)
- •7. History of CCHF anti-viral treatment within 60 days prior to vaccination
- •8. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- •9. Any history of anaphylaxis in relation to vaccination
- •10. Pregnancy, lactation or willingness/intention to become pregnant during the study
- •11. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •12. History of serious psychiatric condition likely to affect participation in the study
- •13. Any other serious, chronic illness requiring hospital specialist supervision
- •14. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
- •15. Suspected or known injecting drug abuse in the 5 years preceding enrolment
- •16. Seropositive for hepatitis B surface antigen (HBsAg)
- •17. Seropositive for hepatitis C virus (antibodies to HCV)
- •18. Known positive HIV test
- •19. History of clinical CCHF
- •20. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
- •21. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study/comply with study requirements or impair interpretation of the study data
- •22. Inability of the study team to contact the volunteer’s GP to confirm medical history and safety to participate
- •Previous exclusion criteria:
- •1. Participation in another research study involving receipt of an investigational product in the 30 days preceding receipt of MVA-CCHF, or planned use during the study period
- •2. Prior receipt of an MVA based vaccine or other investigational vaccine likely to impact on interpretation of the trial data, as assessed by the investigator
- •3. Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe
- •4. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- •5. Confirmed or under investigation for immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication during the pe
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