A Phase I Study to Assess the Safety and Immunogenicity of Novel Schedules for Vaccination With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Vaccine Safety
研究概览
简要总结
This is an open label phase I study, to assess the safety and immunogenicity of novel schedules for vaccination with the candidate malaria vaccines AdCh63 ME-TRAP and MVA ME-TRAP. These vaccines have been evaluated previously in a number of clinical trials proved to be safe and capable of inducing protective cellular immune response following challenge with the parasite. All volunteers recruited will be healthy adults. They will be primed with AdCh63 ME-TRAP administered intramuscularly and boosted several times with AdCh63 ME-TRAP and MVA ME-TRAP according to various schedules.. Safety data will be collected for each of the seven regimens. Secondary aims of this study will be to assess the immune responses generated by each of these regimes.
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 their medical history with their General Practitioner
- •For female volunteers, willingness to practice continuous effective contraception during the study
- •Agreement to refrain from blood donation during the course of the study
- •Written informed consent
排除标准
- •Participation in another research study involving 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)
- •Pregnancy, lactation, or intention to become pregnant during the study
- •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 relation to vaccination
- •Any history of malaria Travel to a malaria endemic region during the study period or within the six months preceding enrolment in the study
- •History of serious psychiatric condition that may 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 five years preceding enrolment -Seropositive for hepatitis B surface antigen (HBsAg)
- •Seropositive for hepatitis C virus (antibodies to HCV)
- •Any relevant history of cancer (excludes basal cell carcinoma of the skin and cervical carcinoma in situ)
- •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 study data
结局指标
主要结局
Vaccine Safety
时间窗: Participants will be followed for the duration of the study, an expected average of 21 months
To assess the safety of vaccination of healthy adults with AdCh63 ME-TRAP and MVA ME-TRAP according to vaccination schedules 1 to 7
次要结局
- Vaccine immunogenicity(Participants will be followed for the duration of the study, an expected average of 21months)