Assessment of Protection Against Malaria by Sporozoite Challenge of Healthy Adults Vaccinated With AdCh63 ME-TRAP and MVA ME-TRAP
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Vaccine prevention (partial or complete) of malaria infection by sporozoite challenge
研究概览
简要总结
Malaria affects around 515 million people each year, about a million of whom die from the disease. It is a major problem for those who live in affected areas as well as for travellers to affected areas. There is a great need for a safe, effective malaria vaccine. The purpose of this study is to test 2 new vaccination regimes that include a new malaria vaccine candidate, for their ability to prevent malaria infection.
The vaccines are different types of virus which contain genetic information (DNA) from the malaria parasite. This genetic material is named ME-TRAP. The aim is to use these viruses to help the body make an immune response against the malaria parasite. Both viruses are inactivated so that they are unable to multiply within the body.
The first vaccine virus is a weakened version of a common cold virus. Such adenoviruses occur in many strain types and commonly infect chimpanzees as well as people and this vaccine uses a strain originally derived from a chimpanzee. The vaccine is called AdCh63 ME-TRAP.
The other virus is Modified Vaccinia Ankara Virus, (MVA), which is a safer form of the vaccine virus previously widely used for smallpox vaccination. The vaccine is called MVA ME-TRAP.
This study will enable the investigators to assess:
- The ability of different vaccine combinations to prevent malaria infection
- The safety of the vaccine combinations in healthy volunteers
- The response of the human immune system to the vaccines
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
- •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 practise effective contraception throughout 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 encoding ME-TRAP 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
- •Contraindication to both anti-malarial drugs (Riamet® and chloroquine)
- •o concomitant use with other drugs known to cause QT-interval prolongation, ( e.g. macrolides, quinolones, amiodarone etc)
- •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
- •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
- •Seropositive for hepatitis B surface antigen (HBsAg)
- •Seropositive for hepatitis C virus (antibodies to HCV)
- •Seropositive for simian adenovirus 63 (antibodies to AdCh63) at a titre > 1: 200 ( EXCEPT CONTROL VOLUNTEERS)
- •Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study.
- •History of clinical P. falciparum malaria
- •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 finding which in the opinion of the investigators would significantly increase the risk of having an adverse outcome from participating in the protocol or impair interpretation of the study data.
研究组 & 干预措施
Group 1
AdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 3 weeks after boost
干预措施: AdCh63 ME-TRAP (Biological)
Group 1
AdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 3 weeks after boost
干预措施: Sporozoite challenge (Other)
Group 2
AdCh63 ME-TRAP alone followed by sporozoite challenge 3 weeks later
干预措施: AdCh63 ME-TRAP (Biological)
Group 2
AdCh63 ME-TRAP alone followed by sporozoite challenge 3 weeks later
干预措施: Sporozoite challenge (Other)
Group 3
Non-vaccinated Control for Groups 1 and 2 challenged with sporozoite
干预措施: Sporozoite challenge (Other)
Group 4
AdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 11 weeks after boost
干预措施: AdCh63 ME-TRAP (Biological)
Group 4
AdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 11 weeks after boost
干预措施: Sporozoite challenge (Other)
Group 5
AdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 3 weeks after boost
干预措施: AdCh63 ME-TRAP (Biological)
Group 5
AdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 3 weeks after boost
干预措施: Sporozoite challenge (Other)
Group 6
Protected volunteers from Group 1 re-challenged with sporozoite after 6 months
干预措施: AdCh63 ME-TRAP (Biological)
Group 6
Protected volunteers from Group 1 re-challenged with sporozoite after 6 months
干预措施: Sporozoite challenge (Other)
Group 7
Non vaccinated control for Groups 4-6, 8-10 challenged with sporozoite
干预措施: Sporozoite challenge (Other)
Group 8
3 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 8 weeks interval each followed by sporozoite challenge 3 weeks after last vaccination
干预措施: Sporozoite challenge (Other)
Group 8
3 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 8 weeks interval each followed by sporozoite challenge 3 weeks after last vaccination
干预措施: Mixture of AdCh63 ME-TRAP and MVA ME-TRAP intramuscularly (Biological)
Group 9
2 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 8 weeks interval followed by sporozoite challenge 3 weeks after last vaccination
干预措施: Sporozoite challenge (Other)
Group 9
2 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 8 weeks interval followed by sporozoite challenge 3 weeks after last vaccination
干预措施: Mixture of AdCh63 ME-TRAP and MVA ME-TRAP intramuscularly (Biological)
Group 10
3 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 4 weeks interval each followed by sporozoite challenge 3 weeks after last vaccination
干预措施: Sporozoite challenge (Other)
Group 10
3 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 4 weeks interval each followed by sporozoite challenge 3 weeks after last vaccination
干预措施: Mixture of AdCh63 ME-TRAP and MVA ME-TRAP intramuscularly (Biological)
Group 5
AdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 3 weeks after boost
干预措施: MVA ME-TRAP (Biological)
Group 4
AdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 11 weeks after boost
干预措施: MVA ME-TRAP (Biological)
Group 1
AdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 3 weeks after boost
干预措施: MVA ME-TRAP (Biological)
结局指标
主要结局
Vaccine prevention (partial or complete) of malaria infection by sporozoite challenge
时间窗: Approxiamately 5-16 months following last intervention
次要结局
- Safety of vaccine(Approxiamately 5-16 months following last intervention)