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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00121771
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
University of Oxford
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine
  Purpose
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
Malaria Biological: FP9 CS Biological: MVA CS Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Brian Greenwood, 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

  Eligibility

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
Criteria

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
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): NCT00121771


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
University of Oxford
Investigators
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
ClinicalTrials.gov Identifier: NCT00121771     History of Changes
Other Study ID Numbers: ITDCVG28
VAC 026
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
Vaccines
Safety
Immunogenicity

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