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

This study has been completed.
Medical Research Council
University of Oxford
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine Identifier:
First received: July 18, 2005
Last updated: January 11, 2017
Last verified: January 2017
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 Intervention Phase
Biological: FP9 CS
Biological: MVA CS
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Safety and immunogenicity

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

Estimated Enrollment: 32
Study Start Date: January 2004
Estimated Study Completion Date: July 2004
  Show Detailed Description


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00121771

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
Study Chair: Adrian VS Hill, MD, Phd Centre for Human Genetics, University of Oxford
  More Information

Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine Identifier: NCT00121771     History of Changes
Other Study ID Numbers: ITDCVG28
VAC 026
Study First Received: July 18, 2005
Last Updated: January 11, 2017

Keywords provided by London School of Hygiene and Tropical Medicine:

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017