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

This study has been completed.
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Medical Research Council
University of Oxford
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00121771
First received: July 18, 2005
Last updated: August 3, 2005
Last verified: July 2005
  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
Endpoint Classification: Safety Study
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 Gates Malaria Partnership:

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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: NCT00121771

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

No publications provided

ClinicalTrials.gov Identifier: NCT00121771     History of Changes
Other Study ID Numbers: ITDCVG28, VAC 026
Study First Received: July 18, 2005
Last Updated: August 3, 2005
Health Authority: Gambia: Department of State for Health and Social Welfare

Keywords provided by Gates Malaria Partnership:
Malaria
Vaccines
Safety
Immunogenicity

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on September 16, 2014