EUCTR2016-001718-31-GB进行中（未招募）1 期
A Phase I/IIa clinical trial to assess the safety, immunogenicity and efficacy of the blood-stage Plasmodium falciparum malaria vaccine candidate RH5.1/AS01 - Safety, immunogenicity and efficacy of RH5.1/AS01 (VAC063)
niversity of Oxford, CTRG0 个研究点目标入组 84 人开始时间: 2016年7月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •The volunteer must satisfy all the following criteria to be eligible for the study:
- •Healthy adults aged 18 to 45 years.
- •Able and willing (in the Investigator’s opinion) to comply with all study requirements.
- •Willing to allow the Investigators to discuss the volunteer’s medical history with their General Practitioner (GP).
- •For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination, and on the day prior to blood-stage CHMI, and prior to the start of antimalarial treatment for Group 5-9 volunteers.
- •Agreement to refrain from blood donation during the course of the study.
- •Provide written informed consent.
- •Additional Inclusion Criteria for Groups 5 - 9
- •Agreement to permanently refrain from blood donation, as per current UK Blood Transfusion and Tissue Transplantation Services guidelines.
- •Reachable (24 hours a day) by mobile phone during the period between CHMI and completion of antimalarial treatment.
- •Willingness to take a curative anti-malaria regimen following CHMI.
- •Answer all questions on the informed consent questionnaire correctly.
- •For Groups 7-8: completion of primary challenge, curative antimalarials and follow-up (up until at least the C+28 visit)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 84
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The volunteer may not enter the study if any of the following apply:
- •Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.
- •Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data. For Group 7 volunteers undergoing re-challenge, this exclusion criterion does not extend to the RH5.1/AS01B vaccine previously received.
- •Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
- •Any confirmed or suspected 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.
- •Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
- •Chronic use of antibiotics with antimalarial effects (e.g. tetracyclines for dermatologic patients, sulfa for recurrent urinary tract infections, etc.).
- •History of malaria chemoprophylaxis within 60 days prior to vaccination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Any history of anaphylaxis in relation to vaccination.
- •History of splenectomy.
- •Pregnancy, lactation or willingness/intention to become pregnant during the study.
- •History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- •History of serious psychiatric condition likely to affect participation in the study.
- •Any other serious chronic illness requiring hospital specialist supervision.
- •Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.
- •Suspected or known injecting drug abuse in the 5 years preceding enrolment.
- •Seropositive for hepatitis B surface antigen (HBsAg).
- •Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV RNA PCR at screening for this study).
- •History of clinical malaria (any species). (Not applicable to Groups 7 and 8).
- •Travel to a malaria endemic region during the study period or within the previous six months.
- •Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis.
- •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.
研究者
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