A Phase I Study to Assess the Safety and Immunogenicity of the Polyprotein Malaria Vaccine Candidates FP9 PP and MVA PP in Healthy Adults Using a Prime-Boost Delivery Schedule
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Immediate reactogenicity
研究概览
简要总结
This study examines two new malaria vaccines (FP9-PP and MVA-PP) in healthy human volunteers to determine their safety and ability to induce a measurable immune response against malaria.
详细描述
Malaria infection kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is clearly a great need for a safe effective malaria vaccine.
The purpose of this study is to test two candidate malaria vaccines (FP9-PP and MVA-PP) in different concentrations and combinations. These live viral vectors encode a 'polyprotein' of six fused malaria antigens expressed at liver and blood stages of the malaria parasite lifecycle. MVA-PP uses the Modified Virus Ankara vector, a weakened form of the smallpox vaccine, vaccinia. FP9-PP uses a highly attenuated avian pox virus (FP9) as the vector instead. The two vaccines will be used in combination in a 'prime boost' strategy to enhance the response of the cellular immune system.
This study will:
- Examine safety
- Examine immunogenicity
- Provide a subgroup of vaccinated volunteers to test clinical efficacy in the following malaria challenge study (VAC027.2)
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
- •Resident in or near Oxford, UK for the duration of the vaccination study
- •Willingness to allow the investigators to access hospital and General Practitioner medical notes
- •For females only, willingness to practice continuous effective contraception during the study and if participating, during the subsequent challenge study.
- •Agreement to refrain from blood donation during the course of the study
- •Written informed consent
- •Willingness to undergo an HIV test
排除标准
- •Any deviation from the protocol-defined normal range in biochemistry or haematology blood tests or in urine analysis
- •Prior receipt of an investigational malaria vaccine
- •Use of any investigational or non-registered drug, vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
- •Administration of chronic immunosuppressive drugs or other immune modifying drugs within six months of vaccination
- •History of malaria chemoprophylaxis with chloroquine within 5 months prior to the planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet within 2 weeks prior to the challenge
- •Any history of malaria
- •Travel to a malaria endemic country within the previous 6 months prior to the planned challenge
- •Planned travel to malarious areas during the study period
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
- •Evidence of cardiovascular disease
- •History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •History of haemoglobinopathies
- •History of diabetes mellitus
- •Chronic or active neurological disease
- •Chronic gastrointestinal disease
- •History of more than 2 hospitalisations for invasive bacterial infections
- •Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
- •Seropositive for hepatitis B surface antigen (HBsAg)
- •Seropositive for hepatitis C virus (antibodies to HCV)
- •Hepatomegaly, right upper quadrant abdominal pain or tenderness
- •Evidence of serious psychiatric condition
- •Any other on-going chronic illness requiring hospital specialist supervision
结局指标
主要结局
Immediate reactogenicity
Adverse events occurring before the end of the trial
Biological safety (haematological and biochemical indices)
次要结局
- T-cell immunogenicity (prime-boost groups)
- Humoral immunogenicity (prime-boost groups)
- Gene expression (prime-boost groups)