NCT02181088已完成1 期
A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of New Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 RH5 Alone and With MVA RH5
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- To assess the safety of ChAd63 RH5 when administered alone and in heterologous prime-boost with MVA RH5
研究概览
简要总结
The purpose of this study is to assess two new malaria vaccines, ChAd63 RH5 and MVA RH5, at different doses and alone or in combination. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. We will do this by giving volunteers one or two vaccinations, doing blood tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use these vaccines in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18 to 50 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
- •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
- •Agreement to refrain from blood donation during the course of the study
- •Provide written informed consent
排除标准
- •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.
- •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 human immunodeficiency virus (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)
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products.
- •Any history of anaphylaxis in reaction to vaccination
- •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
- •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)
- •History of clinical malaria (any species)
- •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
- •Inability of the study team to contact the volunteer's general practitioner (GP) to confirm medical history and safety to participate
结局指标
主要结局
To assess the safety of ChAd63 RH5 when administered alone and in heterologous prime-boost with MVA RH5
时间窗: 240 days
Occurrence of solicited and unsolicited adverse events will be monitored at each clinic visit from diary cards, clinical review, clinical examination (including observations) and laboratory results.
次要结局
- To assess the cellular and humoral immunogenicity of ChAd63 RH5 when administered alone, and in heterologous prime-boost with MVA RH5 in healthy volunteers.(240 days)
研究者
研究点 (3)
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