Status:
COMPLETED
Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02A in Healthy PPD-positive Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Tuberculosis (TB)
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety, reactogenicity and immunogenicity of Mtb72F/AS02A in healthy European volunteers who are PPD-positive either via previous vaccination with BCG and/or conversion to...
Detailed Description
The BCG vaccine has been widely available for several decades. It is easy and cheap to produce, and when given to neonates or young children it is effective in preventing severe manifestations of dise...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Written informed consent
- Healthy PPD-positive volunteers aged 18 to 50 years
- No active pulmonary disease as confirmed by chest X-ray
- No history of extrapulmonary TB
- 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 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 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00146744
Start Date
July 1 2005
End Date
May 1 2006
Last Update
May 30 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Lausanne, Switzerland, 1011