A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of New Plasmodium Vivax Malaria Vaccine Candidates ChAd63 PvDBP Alone and With MVA PvDBP
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The safety in healthy volunteers of two new candidate malaria vaccines, ChAd63 PvDBP administered alone, and with MVA PvDBP, in a prime-boost regime.
研究概览
简要总结
This is an open label phase Ia study, to assess the safety of two novel malaria vaccines, ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can importantly also induce antibodies. Previous clinical trials using this regimen expressing ME-TRAP, AMA1 & MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide comparability with previous ChAd63-MVA trials, we propose to use a similar administration schedule.
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 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 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, Kathon.
- •History of clinically significant contact dermatitis.
- •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) with positive PCR for hepatitis C at screening.
- •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 GP to confirm medical history and safety to participate.
结局指标
主要结局
The safety in healthy volunteers of two new candidate malaria vaccines, ChAd63 PvDBP administered alone, and with MVA PvDBP, in a prime-boost regime.
时间窗: Up to 20 weeks post first vaccination
To assess the safety of ChAd63 PvDBP when administered alone and in heterologous prime-boost with MVA PvDBP. Safety will be assessed by the frequency, incidence and nature of adverse events and serious adverse events arising during the study as well as abnormalities in Hematology and Biochemistry lab tests.
次要结局
- The humoral and cellular immunogenicity of ChAd63 PvDBP, when administered to healthy volunteers alone and with MVA PvDBP.(U to 20 weeks post first vaccination.)