PACTR201310000683408Other未知
Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A With Alhydrogel® Or GLA-SE As Adjuvant: A Staggered, Antigen And Adjuvant Dose-Finding, Randomized, Multi-Centre Phase Ia/Ib Trial
适应症
试验速览
- 阶段
- 未知
- 状态
- Other
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Year(s) 至 45 Year(s)（—）
- 性别
- All
入选标准
- •Healthy volunteers aged 18-45 years
- •General good health based on history and clinical examinationWritten informed consent obtained before any study procedure
- •Female volunteers practicing contraception before and up to 13 weeks after the last immunisation
- •Available to participate in follow-up for the duration of study (34 weeks)
- •Reachable by phone during the whole study period
- •Phase Ib inclusion criteria
- •Healthy male volunteers aged 18-45 years
- •General good health based on history and clinical examination
- •Written informed consent obtained before any study procedure
- •Available to participate in follow-up for the duration of study (34 weeks)
- •Reachable by phone during the whole study period
- •Having always lived in an area of low malaria transmission
排除标准
- •Previous participation in any malaria vaccine trial
- •Symptoms, physical signs or laboratory values suggestive of systemic disorders which could interfere with the interpretation of the trial results or compromise the health of the volunteers
- •Any clinically significant laboratory abnormalities on screened blood samples
- •Enrolment in any other clinical trial during the whole trial period
- •Intake of chronic medication, especially immunosuppressive agents during the 13 weeks preceding the screening visit or during the trial period except topical and inhaled steroids
- •Volunteers unable to be closely followed for social, geographic or psychological reasons
- •Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
- •Known hypersensitivity to any of the vaccine components
- •Vaccination or infusion of gammaglobulin from 4 weeks prior to the first vaccination and up to 6 weeks after the third vaccination
- •Additional Phase Ia exclusion criteria
- •Positive pregnancy test for females
- •Actively breast feeding females
- •Any history of malaria
- •History of living in a malaria endemic area for more than five (5) years OR living in a malaria endemic area in early childhood.
- •Known exposure to malaria in the previous six (6) months
- •P27A ELISA positive OR parasite ELISA antibody positive AND Known exposure to malaria in a malaria endemic area
- •P27A ELISA positive AND parasite ELISA antibody positive (with or without history of stay in a malaria endemic area)
- •Intention to travel to malaria endemic countries during the study period
- •Positive HIV, HBV or HCV tests
- •Additional Phase Ib exclusion criteria
- •Previous vaccination with the control vaccine
- •Positive HIV, HCV test or HBVsAg positive
- •Malaria parasite positivity by microscopy and/or RDT
- •Having had a history of confirmed malaria episode in the last five year
研究者
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