Last updated: 11/02/2018 23:44:07
Safety and immunogenicity of GSK Biological’s candidate tuberculosis vaccine Mtb72F/AS02 in healthy PPD-negative adults.
GSK study ID
102039
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Evaluate the safety, reactogenicity & immunogenicity of 2 antigen dose levels of GSK Biologicals’ candidate tuberculosis vaccine, Mtb72F/AS02 to healthy PPD-negative volunteers aged 18 to 45 yrs
Trial description: 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. Booster vaccination will be given only to subjects receiving the candidate tuberculosis vaccines and not to the subjects receiving active comparators or control.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Mtb72F/AS02.
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Tuberculosis (TB)
Product
SB692342
Collaborators
Not applicable
Study date(s)
July 2004 to May 2005
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- Written informed consent
- Healthy PPD-negative volunteers aged 18 to 45 years
- 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.
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-05-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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