Tuberculosis (TB)
Conditions
Keywords
Tuberculosis vaccine
Brief summary
This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals' candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.
Interventions
Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high)
Sponsors
Corixa Corporation
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female between 18 and 40 years of age at the time of screening * Negative PPD skin test at screening. * Subjects must have chest X-ray showing no evidence of pulmonary pathology. * Female subjects of childbearing potential must have a negative serum pregnancy test at screening, must not be breast-feeding and are required to use adequate contraception from enrolment till 1 month after dose 3. * Screening laboratory values must be within the laboratory normal ranges. * Negative for human immunodeficiency virus-1 and 2 (HIV 1/2) antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. * Subjects must give written informed consent. * Subjects must be willing to make all evaluation visits, be readily reachable by telephone or personal contact by the study site personnel and have a permanent address. * Subjects' resting seated vital signs must be within the protocol-defined ranges.
Exclusion criteria
* History of prior Bacillus Calmette-Guérin (BCG) vaccinations. * History of documented exposure to Mycobacterium tuberculosis. * History of previous administration of experimental Mycobacterium tuberculosis vaccines or previous exposure to experimental products containing components of the experimental vaccine. * History of employment in a healthcare facility in a capacity that had direct or indirect contact with TB patients. * Administration of any immunoglobulins or any immunotherapy within the 3 months preceding the first dose of study vaccination, and/or any blood products within the 4 months preceding HIV screening, or planned administrations during the study period. * Use of St. John's Wort within six months of the Day 0 visit or planned administrations during the study period. * Participation in another experimental protocol and/or receipt of any investigational products within 30 days prior to Day 0. * History of autoimmune disease or causes of immunosuppressive states. * 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. * History of significant psychiatric illness. * Current drug or alcohol abuse * History of previous anaphylaxis or severe allergic reaction to vaccines or any other allergen. * Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol. * Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements (including mineral preparations such as calcium carbonate), herbal medications except St. John's Wort, birth control pills, anti-histamines for seasonal allergies, SSRIs (e.g. Prozac, Zoloft, Paxil), NSAIDs (e.g. aspirin, ibuprofen), and acetominophen. * Chronic administration (defined as more than 14 days total) of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. * History of chronic or intermittently recurring illnesses such as migraine headaches, diabetes, heart disease, and asthma. * Current administration of anti-TB prophylaxis or therapy. * History of administration of a live attenuated virus vaccine within 30 days of enrollment. * History of administration of a subunit or killed vaccine within 14 days of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chest X-ray findings | At study start and study end |
| Laboratory measurements of serum chemistry and hematology | At study start, prior to each vaccination and 1 and 6 months after dose 3 |
| Resting vital signs (blood pressure, pulse, temperature) | At study start, prior to each vaccination and 1 and 6 months after dose 3 |
| Occurrence of dose limiting toxicity | From study start up to Day 56. |
| Occurrence of serious adverse events | During the entire study period. |
| Occurrence of adverse events | At each visit |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of PPD skin reactivity | At study start and study end |
| Evaluation of T cell and antibody responses to the fusion protein and to each of the three Mycobacterium tuberculosis antigen domains. | Prior to each vaccination and 1 and 6 months after dose 3 |
Countries
United States
Outcome results
None listed