Status:
TERMINATED
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease
Lead Sponsor:
GlaxoSmithKline
Conditions:
Tuberculosis
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
Brief Summary
This study will assess the safety and immunogenicity of GSK Biologicals' investigational tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months to human immunodefi...
Detailed Description
A Protocol Amendment 1, May 2012, was made following the decision to add a second country in the study (i.e. Estonia).
Eligibility Criteria
Inclusion
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- A male or female between, and including, 18 and 59 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
- Seronegative for HIV- 1 and -2 antibodies.
- No history of or current extrapulmonary tuberculosis TB. Additionally, based on medical history,
- Subjects in the TB-naive cohort must
- have no active pulmonary disease as indicated by chest X-ray.
- have no signs and symptoms of TB.
- have no history of chemoprophylaxis or treatment for TB.
- Subjects in the TB-treated cohort must
- have a history of successful treatment for pulmonary TB (completed at least 1 year prior to vaccination).
- have no active pulmonary disease on chest X-ray.
- Subjects in the TB-treatment cohort must - have documented treatment for pulmonary TB (smear- or culture confirmed) ongoing for 2-4 months prior to vaccination.
Exclusion
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Any chronic drug therapy to be continued during the study period, which in the opinion of the investigator could adversely interfere with the vaccine.
- History of previous administration of experimental TB vaccines.
- History of previous exposure to components of the investigational vaccine within 30 days preceding the first dose of study vaccine.
- Administration of any immunoglobulins, any immunotherapy and/or any blood products within the 3 months preceding the first dose of study vaccination, or planned administrations during the study period.
- Planned participation or participation in another experimental protocol during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- History of chronic alcohol and/or drug abuse.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects.
- Pregnant female, lactating female or female planning to become pregnant or discontinue contraceptive precautions during the active phase of the study (from study start till 2 months after dose 2).
- Additionally, for the TB naïve and TB treated cohorts:
- \- Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or laboratory screening tests
- Additionally, for the TB treatment cohort:
- Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or laboratory screening tests. Individuals with grade 3 levels will be excluded.
- Failure to convert while on anti-TB treatment at the end of the second month of anti-TB therapy.
Key Trial Info
Start Date :
November 14 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2014
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT01424501
Start Date
November 14 2011
End Date
April 10 2014
Last Update
August 20 2018
Active Locations (6)
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1
GSK Investigational Site
Tallinn, Estonia, 10117
2
GSK Investigational Site
Tartu, Estonia, 51014
3
GSK Investigational Site
Taipei, Taiwan, 100
4
GSK Investigational Site
Taipei, Taiwan, 220