Malaria Infection Diagnosed by Polymerase Chain Reaction (PCR) as a Means of Evaluating Pre-erythrocytic Candidate Malaria Vaccines
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ClinicalTrials.gov Identifier: NCT00121823
Recruitment Status :
First Posted : July 21, 2005
Last Update Posted : January 12, 2017
London School of Hygiene and Tropical Medicine
Medical Research Council Unit, The Gambia
University of Oxford
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine
The ability to test candidate pre-erythrocytic stage malaria vaccines, using a well-established sporozoite challenge model, in a field setting with group sizes of tens rather than hundreds of volunteers would greatly facilitate identification of the most promising vaccine candidates. The investigators assessed the suitability and acceptability of this method in a field trial in semi-immune volunteers exposed to natural infection during the high malaria transmission season.
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Ages Eligible for Study:
15 Years to 45 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy volunteers aged 15-45 years
Signed informed consent form
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 immunosuppression.
History of splenectomy
Haematocrit of less than 30%
Serum creatinine concentration >130mmol/L
Serum ALT concentration >80 IU/L
Blood transfusion within one month of the beginning of the study
History of vaccination with a previous experimental malaria vaccine
Administration of any other vaccine or immunoglobulin within two weeks of scheduled vaccination.
Positive HIV antibody test.
Positive colorimetric test for G-6-P-D deficiency.
Current participation in another clinical trial, or within 12 weeks of this study.
Lack of parental consent if volunteer is aged under 18
Likelihood of travel away from the study area for the duration of the study
Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial
Known allergy to sulfadoxine/pyrimethamine (SP), Artesunate or Lapdap