Malaria Candidate Vaccines FP9 Circumsporozoite (CS) and MVA CS in Adult Gambian Men
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ClinicalTrials.gov Identifier: NCT00121771
Recruitment Status :
First Posted : July 21, 2005
Last Update Posted : January 12, 2017
London School of Hygiene and Tropical Medicine
Medical Research Council
University of Oxford
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine
Animal and human studies have shown that the prime-boost immunization strategy using malaria antigens expressed in plasmid or viral vectors induces strong cellular immune responses. An immunization regimen with the malaria vaccines DNA ME-TRAP followed by MVA ME-TRAP induced strong T cell responses in adults in the United Kingdom (UK) and in the Gambia but did not provide significant clinical protection against infection. The investigators assessed two new vaccines which utilize a similar immunization strategy but a different malaria antigen, a circumsporozoite (CS) protein. The entire CS protein was expressed either in a modified vaccinia virus Ankara (MVA) CS, or an attenuated fowlpox virus strain (FP9) CS.
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy adult male aged 18-45 years
Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease or neurological illness
Any clinical evidence of immunosuppression such as oral candida, stomatitis, aphthous or septic ulceration, septic skin lesions or any clinical or laboratory evidence of infection or immunocompromise
History of splenectomy
Haematocrit of less than 30%
Serum creatinine concentration >130mmol/L
Serum ALT concentration >42IU/L
Blood transfusion within one month of the beginning of the study
Administration of any other vaccine or immunoglobulin within two weeks before scheduled MVA vaccination
Positive HIV antibody test
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 for the duration of the study