ISRCTN95289709进行中（未招募）1 期
Phase I clinical trial to assess the safety and immunogenicity of the malaria vaccine candidate RH5.1 soluble protein in Matrix-MTM using two dosing regimens
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 23
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 adult aged 18 to 50 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 GP
- •4. Participants of childbearing potential only: must practice continuous effective contraception for the duration of the study (see section 9.9)
- •5. Agreement to refrain from blood donation for the duration of the study
- •6. Able and willing to provide written informed consent to participate in the trial
排除标准
- •1. History of clinical malaria (any species) or previous participation in any malaria (vaccine) trial or controlled human malaria infection (CHMI) study
- •2. Travel to a clearly malaria endemic locality during the study period or within the preceding 6 months
- •3. Use of immunoglobulins or blood products (e.g. blood transfusion) in the last 3 months
- •4. Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each study vaccination, with the exception of COVID-19 vaccines, which should not be received between 14 days before to 7 days after any study vaccination
- •5. Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period
- •6. Concurrent involvement in another clinical trial involving an investigational product or planned involvement during the study period
- •7. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data, as assessed by the Investigator
- •8. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- •9. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- •10. Any history of anaphylaxis
- •11. Pregnancy, lactation or intention to become pregnant during the study
- •12. Body mass index of <18.5 or >35
- •13. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •14. History of serious psychiatric condition that may affect participation in the study
- •15. Any other serious chronic illness requiring hospital specialist supervision
- •16. Suspected or known current alcohol misuse as defined by an alcohol intake of greater than 25 standard UK units every week
- •17. Suspected or known injecting drug use in the 5 years preceding enrolment
- •18. Hepatitis B surface antigen (HBsAg) detected in serum
- •19. Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless volunteer has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV ribonucleic acid (RNA) PCR at screening for this study)
- •20. Volunteers unable to be closely followed for social, geographic or psychological reasons.
- •21. Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat tests will be requested. Procedures for identifying laboratory values meeting exclusion criteria are shown in SOP VC027
- •22. 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 or impair interpretation of the study data
- •23. Inability of the study team to contact the volunteer’s GP to confirm medical history and safety to participate
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