Status:
COMPLETED
Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02 in Healthy PPD-negative Adults.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Tuberculosis (TB)
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Vaccination against tuberculosis (TB) /healthy PPD-negative adults aged 18 to 45 years.Three doses of primary vaccination followed by a booster dose after completion of primary vaccination course. Boo...
Detailed Description
The safety and immunogenicity of 2 antigen doses in PPD-negative adults will be evaluated. In addition, 2 active comparator groups of volunteers will receive the vaccine alone without an immunostimula...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Written informed consent
- Healthy PPD-negative volunteers aged 18 to 45 years
- No evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past TB infection/disease) as confirmed by chest X-ray.
- Seronegative for HIV 1 and 2, HBsAg, and HCV
- Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, complete blood count (CBC) and differential, haemoglobin, platelet count and urinalysis.
- Females : Non pregnant, must use adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
- EXCLUSION CRITERIA:
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
- History of prior Bacillus Calmette-Guérin (BCG) vaccination.
- History of documented exposure to Mycobacterium tuberculosis
- History of prior vaccination with experimental Mycobacterium Tuberculosis vaccines or experimental products containing MPL or QS21.
- Any confirmed or suspected immunosuppressive or immunodeficient condition; or family history of congenital or hereditary immunodeficiency.
- History of hypersensitivity to vaccines or vaccine components
- History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00291889
Start Date
July 1 2004
End Date
May 1 2005
Last Update
May 30 2017
Active Locations (1)
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1
GSK Investigational Site
Ghent, Belgium, 9000