Assessment of protection against malaria by sporozoite challenge of healthy adults vaccinated with the virosomal vaccine PEV3A and FP9-MVA ME-TRAP - Efficacy of the malaria vaccines PEV3A and FP9-MVA ME-TRAP

niversity of Oxford0 个研究点目标入组 48 人开始时间: 2005年5月11日最近更新: 2019年11月25日

适应症

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•Healthy adults aged 18 to 50 years
•Written informed consent
•Resident in or near Oxford for the duration of the vaccination study
•For females only, willingness to practice continuous effective contraception during the study and during the subsequent challenge study
•Agreement to refrain from blood donation during the course of the study
•Willingness to undergo an HIV test
•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

•Abnormal biochemistry or haematology blood tests or urine analysis (see Appendix A of trial protocol)
•Use of any investigational or non-registered drug, live 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 immunosuppressants or other immune modifying drugs within 6 months of vaccination
•Any history of malaria, travel to a malaria endemic country within the previous 3 months prior to the study
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV and asplenia
•Seropositive for hepatitis B or C
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
•Any on-going chronic illness requiring hospital specialist supervision

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