Malaria Infection Diagnosed by Polymerase Chain Reaction (PCR) as a Means of Evaluating Pre-Erythrocytic Candidate Malaria Vaccines

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014