Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01424501
First received: August 25, 2011
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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 immunodeficiency virus (HIV) negative adults who have received treatment for TB disease (denoted TB-treated cohort) or are currently receiving treatment for TB disease (denoted TB-treatment cohort). For comparative purposes, subjects who have never had TB disease (denoted TB-naïve cohort) will also be enrolled.


Condition Intervention Phase
Tuberculosis
Biological: GSK Biologicals' investigational TB vaccine GSK 692342
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342 When Administered to Adults With TB Disease

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of solicited adverse events (AEs). [ Time Frame: During the 7-day follow-up period following vaccination (day of vaccination and 6 subsequent days after each vaccine dose). ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited AEs. [ Time Frame: During the 30-day follow-up period following vaccination (day of vaccination and 29 subsequent days after each vaccine dose). ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events (SAEs). [ Time Frame: From screening (between Day -59 and Day -3) up to Day 210. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cell mediated immunogenicity (CMI) with respect to components of the study vaccine [ Time Frame: Prior to dose 1 (Day 0), post dose 1 (Days 7 and 30) and post dose 2 (Days 37, 60 and 210) ] [ Designated as safety issue: No ]
  • Humoral immunogenicity with respect to components of the study vaccine in terms of antibody concentrations [ Time Frame: Prior to dose 1 (Day 0), post dose 1 (Day 30) and post dose 2 (Days 60 and 210) ] [ Designated as safety issue: No ]
  • Humoral immunogenicity with respect to components of the study vaccine in seropositivity rates [ Time Frame: Prior to dose 1 (Day 0), post dose 1 (Day 30) and post dose 2 (Days 60 and 210) ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects from TB-treated cohort will receive 2 doses of GSK's investigational vaccine GSK 692342.
Biological: GSK Biologicals' investigational TB vaccine GSK 692342
Intramuscular injection, 2 doses
Placebo Comparator: Group B
Subjects from TB-treated cohort will receive 2 doses of physiological Saline.
Biological: Placebo
Intramuscular injection, 2 doses
Experimental: Group C
Subjects from TB-treatment cohort will receive 2 doses of GSK's investigational vaccine GSK 692342.
Biological: GSK Biologicals' investigational TB vaccine GSK 692342
Intramuscular injection, 2 doses
Placebo Comparator: Group D
Subjects from TB-treatment cohort will receive 2 doses of physiological Saline.
Biological: Placebo
Intramuscular injection, 2 doses
Experimental: Group E
Subjects from TB-naive cohort will receive 2 doses of GSK's investigational vaccine GSK 692342.
Biological: GSK Biologicals' investigational TB vaccine GSK 692342
Intramuscular injection, 2 doses
Placebo Comparator: Group F
Subjects from TB-naive cohort will receive 2 doses of physiological Saline.
Biological: Placebo
Intramuscular injection, 2 doses

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

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424501

Locations
Estonia
GSK Investigational Site
Tallinn, Estonia, 10117
GSK Investigational Site
Tartu, Estonia, 51014
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan
GSK Investigational Site
Taipei, Taiwan, 220
GSK Investigational Site
Taoyuan Hsien, Taiwan, 333
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01424501     History of Changes
Other Study ID Numbers: 114886
Study First Received: August 25, 2011
Last Updated: February 13, 2014
Health Authority: Taiwan: Department of Health, Executive Yuan, R.O.C.

Keywords provided by GlaxoSmithKline:
Tuberculosis vaccine
HIV-negative
tuberculosis treatment

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 23, 2014