This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine administered at 0, 1 months to healthy adults living in a TB-endemic region. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
45
Intramuscular injection, 2 doses at 0, 1 month
GSK Investigational Site
Worcester, Western Province, South Africa
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
Time frame: During the 7-day follow-up period following vaccination after each vaccine dose
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Time frame: During the 30-day follow-up period following vaccination after each vaccine dose
Occurrence and relationship to vaccination of serious adverse events
Time frame: During the entire study period
Haematological and biochemical levels
Time frame: At protocol defined time points
Analysis of cytokine expression by M72-specific CD4+/CD8+ T cells by means of invitro flow cytometry
Time frame: At protocol defined time points
Antibody titres to M72 measured by ELISA
Time frame: At protocol defined time points
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