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: 2012年3月19日

适应症

试验速览

暂无简介。

•- 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

发起方

INSTITUT PASTEUR, Biomedical Parasitology Unit