Last updated: 11/02/2018 23:51:18
Safety and immunogenicity of GSK Biological’s candidate tuberculosis vaccine Mtb72F/AS02A in healthy PPD-positive adults
GSK study ID
102374
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Double-blind (observer-blind), randomised, controlled, phase I/II study, to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' candidate tuberculosis vaccine, Mtb72F/AS02A administered intramuscularly at 0, 1, 2 months to healthy PPD-positive volunteers aged 18 to 50 years
Trial description: 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 PPD positivity through exposure to Mycobacterium tuberculosis.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Mtb72F/AS02A
Enrollment:
38
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 2005 to May 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
- INCLUSION CRITERIA
- Written informed consent
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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
2006-23-05
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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