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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00121823
First Posted: July 21, 2005
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medical Research Council Unit, The Gambia
University of Oxford
Wellcome Trust
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine
  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
Intervention Model: Single Group Assignment
Masking: Single
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 Brian Greenwood, London School of Hygiene and Tropical Medicine:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121823


Locations
Gambia
Medical Research Council Laboratories
Banjul, Gambia, P.O.Box 273, Banjul
Sponsors and Collaborators
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

Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00121823     History of Changes
Other Study ID Numbers: ITDCVG37
VAC 029
First Submitted: July 18, 2005
First Posted: July 21, 2005
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
Malaria
PCR
Vaccines
Acceptability

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs