Immunogenicity and Safety of a Candidate Tuberculosis (TB) Vaccine Given to Healthy Adults in a TB-endemic Region

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00600782
First received: January 15, 2008
Last updated: September 3, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Tuberculosis (TB)
Biological: GSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of GSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342) When Administered to Healthy Adults Aged 21 to 40 Years.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: During the 30-day follow-up period following vaccination after each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence and relationship to vaccination of serious adverse events [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
  • Haematological and biochemical levels [ Time Frame: At protocol defined time points ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of cytokine expression by M72-specific CD4+/CD8+ T cells by means of invitro flow cytometry [ Time Frame: At protocol defined time points ] [ Designated as safety issue: No ]
  • Antibody titres to M72 measured by ELISA [ Time Frame: At protocol defined time points ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: February 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
These subjects were further stratified into 3 groups according to the size of their PPD skin test reactions
Biological: GSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342)
Intramuscular injection, 2 doses at 0, 1 month

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600782

Locations
South Africa
GSK Investigational Site
Worcester, Western Province, South Africa, 6850
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00600782     History of Changes
Other Study ID Numbers: 110347
Study First Received: January 15, 2008
Last Updated: September 3, 2009
Health Authority: South Africa: Medicines Control Council

Keywords provided by GlaxoSmithKline:
Tuberculosis vaccine

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

ClinicalTrials.gov processed this record on July 29, 2014