Status:
COMPLETED
A Phase I Study of the Safety and Immunogenicity of MVA85A in Healthy Gambian Volunteers
Lead Sponsor:
University of Oxford
Conditions:
Tuberculosis
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
A Phase I study of the Safety and immunogenicity of MVA85A in healthy Gambian volunteers
Detailed Description
Study Design: The study is a non-randomized clinical trial. Twelve volunteers will be recruited. They would be given 5x107 pfu of the MVA85A vaccine intradermally. The subjects will be required to sta...
Eligibility Criteria
Inclusion
- Healthy adult male aged 18-45 years.
- Normal medical history and physical examination. Minor physical ailments e.g. Fungal skin infections, will not be sufficient to define a physical examination as abnormal.
- Normal urine dipstick, blood count, liver enzymes, and creatinine
- Frequency \<4 SFU per/well/3x105 PBMC as determined by ELISPOT with ESAT6/CFP-10 antigens and less than 100 SFU per/well/1x106 PBMC as determined by ELISPOT with PPD.
- Mantoux negative (0.0 mm induration).
- Normal Chest X-ray.
- Willing to donate blood samples as required by the protocol
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
- Serum ALT concentration \>80IU/L
- Blood transfusion within one month of the beginning of the study
- History of vaccination with any previous experimental poxvirus vaccine
- Administration of any other vaccine or immunoglobulin within two weeks before or two weeks after vaccination.
- Positive HIV antibody test, evidence of HBV (Hepatitis B vaccination is not an exclusion criteria)..
- 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
- Untreated malaria infection
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00423839
Start Date
March 1 2003
End Date
July 1 2005
Last Update
January 18 2007
Active Locations (1)
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1
MRC Labs
Fajara, Fajara, The Gambia