Malaria Candidate Vaccines FP9 Circumsporozoite (CS) and MVA CS in Adult Gambian Men
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Safety and immunogenicity
- Comparison of immunogenicity with non-immune UK adults
Estimated Enrollment: | 32 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | July 2004 |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders 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
Gambia | |
Medical Research Council Laboratories | |
Banjul, Gambia, P.O.Box 273, Banjul |
Study Chair: | Adrian VS Hill, MD, Phd | Centre for Human Genetics, University of Oxford |
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 October 16, 2012