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Malaria Candidate Vaccines FP9 Circumsporozoite (CS) and MVA CS in Adult Gambian Men

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. Identifier: NCT00121771
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : January 12, 2017
Medical Research Council
University of Oxford
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine

Brief Summary:
Animal and human studies have shown that the prime-boost immunization strategy using malaria antigens expressed in plasmid or viral vectors induces strong cellular immune responses. An immunization regimen with the malaria vaccines DNA ME-TRAP followed by MVA ME-TRAP induced strong T cell responses in adults in the United Kingdom (UK) and in the Gambia but did not provide significant clinical protection against infection. The investigators assessed two new vaccines which utilize a similar immunization strategy but a different malaria antigen, a circumsporozoite (CS) protein. The entire CS protein was expressed either in a modified vaccinia virus Ankara (MVA) CS, or an attenuated fowlpox virus strain (FP9) CS.

Condition or disease Intervention/treatment Phase
Malaria Biological: FP9 CS Biological: MVA CS Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 1 Trial of the Malaria Candidate Vaccines FP9 CS and MVA CS in Adult Gambian Men Aged 18 - 45 Years
Study Start Date : January 2004
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Primary Outcome Measures :
  1. Safety and immunogenicity

Secondary Outcome Measures :
  1. Comparison of immunogenicity with non-immune UK adults

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy adult male aged 18-45 years

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 immunocompromise
  • History of splenectomy
  • Haematocrit of less than 30%
  • Serum creatinine concentration >130mmol/L
  • Serum ALT concentration >42IU/L
  • Blood transfusion within one month of the beginning of the study
  • Administration of any other vaccine or immunoglobulin within two weeks before scheduled MVA vaccination
  • Positive HIV antibody test
  • Current participation in another clinical trial, or within 12 weeks of this study
  • Any other finding which, in the opinion of the investigators, would increase the risk of an adverse outcome from participation in the trial
  • Likelihood of travel away from the study area for the duration of the study

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 identifier (NCT number): NCT00121771

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Medical Research Council Laboratories
Banjul, Gambia, P.O.Box 273, Banjul
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Medical Research Council
University of Oxford
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Study Chair: Adrian VS Hill, MD, Phd Centre for Human Genetics, University of Oxford

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Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine Identifier: NCT00121771     History of Changes
Other Study ID Numbers: ITDCVG28
VAC 026
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:

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