Status:
COMPLETED
Malaria Candidate Vaccines FP9 Circumsporozoite (CS) and MVA CS in Adult Gambian Men
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Medical Research Council
University of Oxford
Conditions:
Malaria
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 re...
Detailed Description
Objectives: The primary aim was the assessment of safety and reactogenicity of these vaccines in Gambian adults. The secondary aim was the assessment of immunogenicity and comparison with UK adults g...
Eligibility Criteria
Inclusion
- Healthy adult male aged 18-45 years
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2004
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00121771
Start Date
January 1 2004
End Date
July 1 2004
Last Update
January 12 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical Research Council Laboratories
Banjul, The Gambia, P.O.Box 273, Banjul