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
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 April 23, 2014