Tuberculosis (TB), Tuberculosis Vaccines
Conditions
Keywords
Tuberculosis vaccine
Brief summary
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.
Interventions
BIOLOGICALGSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342)
Intramuscular injection, 2 doses at 0, 1 month
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the Investigator believes that they can and will comply with the requirements of the protocol. * A male or female between, and including, 21 and 40 years of age at the time of the first vaccination. * Written informed consent obtained from the subject prior to any study procedure. * Free of obvious health problems as established by medical history and clinical examination before enrolment into the study. * If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. * No evidence of pulmonary pathology as confirmed by chest X-ray. * Clinically normal laboratory values for creatinine, ALT, AST and complete blood count. * Seronegative for human immunodeficiency virus-1 (HIV-1). * No history of extrapulmonary TB. * Subjects must have the appropriate PPD skin reactivity (induration measured at 48 to 72 hours after PPD skin test administration).
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. * History of previous administration of experimental Mycobacterium tuberculosis vaccines. * History of previous exposure to experimental products containing MPL or QS21. * Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the first dose of study vaccination, or planned administrations during the study period. * Participation in another experimental protocol during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * A family history of congenital or hereditary immunodeficiency. Subjects who describe a first-degree relative with clearly documented autoimmune disease will be excluded * 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. * Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies, SSRIs. * History of any neurologic disorders or seizures. * History of allergic reactions or anaphylaxis to previous immunisations. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * History of chronic alcohol consumption and/or drug abuse which in the investigators opinion would put the subject at risk. * Major congenital defects. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence, intensity and relationship to vaccination of solicited local and general symptoms | During the 7-day follow-up period following vaccination after each vaccine dose |
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms | During the 30-day follow-up period following vaccination after each vaccine dose |
| Occurrence and relationship to vaccination of serious adverse events | During the entire study period |
| Haematological and biochemical levels | At protocol defined time points |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of cytokine expression by M72-specific CD4+/CD8+ T cells by means of invitro flow cytometry | At protocol defined time points |
| Antibody titres to M72 measured by ELISA | At protocol defined time points |
Countries
South Africa
Outcome results
None listed