Status:
COMPLETED
Malaria Infection Diagnosed by Polymerase Chain Reaction (PCR) as a Means of Evaluating Pre-erythrocytic Candidate Malaria Vaccines
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Medical Research Council Unit, The Gambia
University of Oxford
Conditions:
Malaria
Eligibility:
MALE
15-45 years
Phase:
PHASE1
PHASE2
Brief Summary
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 voluntee...
Detailed Description
Objective The primary objective of the study was to determine if the very sensitive PCR technique, capable of detecting malaria parasites at low densities could be used as an economical method of und...
Eligibility Criteria
Inclusion
- Healthy volunteers aged 15-45 years
- Signed informed consent form
Exclusion
- 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
- Drug or alcohol addiction
- Egg allergy
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00121823
Start Date
June 1 2004
End Date
December 1 2004
Last Update
January 12 2017
Active Locations (1)
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1
Medical Research Council Laboratories
Banjul, The Gambia, P.O.Box 273, Banjul