Safety and immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in children in a malaria endemic area

niversity of Oxford0 个研究点目标入组 36 人开始时间: 2012年2月26日最近更新: 2023年5月29日

适应症

试验速览

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•¿A male or female between, and including, 2 and 6 years of age at the time of the first vaccination.
•¿Written informed consent obtained from the subject¿s parents.
•¿Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•¿Availability for the duration of the immunization and follow-up period.

•¿Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
•¿Severe malnutrition, defined as weight-for-height z-score <-3 or oedema of both feet (WHO)
•¿Hypersensitivity to HDCRV.
•¿History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.
•¿History of splenectomy.
•¿Haemoglobin less than 9.0 g/dL
•¿Serum creatinine concentration above >130mmol/L
•¿Serum ALT concentration >69 IU/L
•¿Blood transfusion within one month of enrolment.
•¿History of vaccination with previous experimental malaria vaccines.
•¿Administration of any other vaccine or immunoglobulin within two weeks before vaccination.
•¿Current participation in another clinical trial, or within 12 weeks of this study.
•¿Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
•¿Likelihood of travel away from the study area.
•¿HIV positive.

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