Malaria Infection Diagnosed by Polymerase Chain Reaction (PCR) as a Means of Evaluating Pre-Erythrocytic Candidate Malaria Vaccines
This study has been completed.
Sponsor:
Gates Malaria Partnership
Collaborators:
London School of Hygiene and Tropical Medicine
Medical Research Council Unit, The Gambia
University of Oxford
Wellcome Trust
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00121823
First received: July 18, 2005
Last updated: July 22, 2005
Last verified: July 2005
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria |
Biological: FP9 ME-TRAP Biological: MVA ME-TRAP |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Prevention |
| Official Title: | Malaria Infection Diagnosed by PCR as a Means of Evaluating Pre-Erythrocytic Candidate Malaria Vaccines |
Resource links provided by NLM:
Further study details as provided by Gates Malaria Partnership:
Primary Outcome Measures:
- Suitability and acceptability of study method
Secondary Outcome Measures:
- Prevention of malaria parasitaemia
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | December 2004 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 15 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy volunteers aged 15-45 years
- Signed informed consent form
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121823
Locations
| Gambia | |
| Medical Research Council Laboratories | |
| Banjul, Gambia, P.O.Box 273, Banjul | |
Sponsors and Collaborators
Gates Malaria Partnership
London School of Hygiene and Tropical Medicine
Medical Research Council Unit, The Gambia
University of Oxford
Wellcome Trust
Investigators
| Study Chair: | Adrian VS Hill, Phd | University of Oxford |
| Study Director: | Brian M Greenwood, MD | Gates Malaria Partnership |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00121823 History of Changes |
| Other Study ID Numbers: | ITDCVG37, VAC 029 |
| Study First Received: | July 18, 2005 |
| Last Updated: | July 22, 2005 |
| Health Authority: | Gambia: Department of State for Health and Social Welfare |
Keywords provided by Gates Malaria Partnership:
|
Malaria PCR Vaccines Acceptability |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013