EUCTR2006-001743-66-NL进行中（未招募）不适用
Phase I and IIa trial to assess the safety, immunogenicity and protective efficacy against sporozoite challenge of the candidate malaria vaccine pfLSA-3 vaccine. - LSA3-trial
INSTITUT PASTEUR, Biomedical Parasitology Unit0 个研究点开始时间: 2006年10月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Healthy male adults, aged 18 to 45 years
- •- Available for a sporozoite challenge following the immunization course
- •- Resident near the Radboud University Medical Center Nijmegen
- •- Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Any history of malaria
- •-Planned to travel to endemic malaria areas during the study period
- •-Prior administration of an investigational malaria vaccine
- •-Participation in any other clinical trial within 90 days prior to the onset of the trial
- •-Body Mass Index <20kg/m2 or > 32 kg/m2
- •-Blood pressure > 150/90 in two measurements
- •-Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers
- •-Seropositive for HIV, HBV or HCV
- •- An estimated, ten year risk of fatal cardiovascular disease of =5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system.
- •-Any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis
- •-The use of chronic medication, especially immunosuppressive agents or antibiotics
- •-Known hypersensitivity to any of the vaccine components
研究者
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