Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00621322
First received: February 12, 2008
Last updated: September 3, 2009
Last verified: September 2009
  Purpose

This observer blind study will assess the safety and immunogenicity of different formulations of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Tuberculosis (TB) Infection
Biological: Control vaccine with physiological saline
Biological: GSK Biologicals' Candidate Tuberculosis Vaccines (692342) - different formulations
Biological: Control vaccine with the adjuvant system.
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dose Range Study Evaluating Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccines (692342) When Administered to Healthy Adults Aged 18 to 45 Years.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Haematological and biochemical levels in each group. [ Time Frame: At protocol defined time points ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of any solicited local and general symptoms in each group. [ 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 any unsolicited symptoms in each group. [ 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 any serious adverse events in each group. [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]

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

Enrollment: 181
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group F Biological: Control vaccine with physiological saline
Intramuscular injection, 2 doses
Placebo Comparator: Group C Biological: Control vaccine with the adjuvant system.
Intramuscular injection, 2 doses
Experimental: Group E Biological: GSK Biologicals' Candidate Tuberculosis Vaccines (692342) - different formulations
Intramuscular injection, 2 doses
Experimental: Group D Biological: GSK Biologicals' Candidate Tuberculosis Vaccines (692342) - different formulations
Intramuscular injection, 2 doses
Experimental: Group A Biological: GSK Biologicals' Candidate Tuberculosis Vaccines (692342) - different formulations
Intramuscular injection, 2 doses
Experimental: Group B Biological: GSK Biologicals' Candidate Tuberculosis Vaccines (692342) - different formulations
Intramuscular injection, 2 doses

  Eligibility

Ages Eligible for Study:   18 Years to 45 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 should be enrolled in the study.
  • A male or female between, and including, 18 and 45 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.
  • No history of extrapulmonary TB.
  • Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and urinalysis.
  • Seronegative for human immunodeficiency virus-1 and -2 (HIV-1 and -2) antibodies.
  • Subjects must have a PPD positive skin reactivity 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 vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • 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, with the exception of vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies and SSRIs.
  • 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.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • A family history (first generation) of congenital or hereditary immunodeficiency.
  • 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 any neurological 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.
  • 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: NCT00621322

Locations
Philippines
GSK Investigational Site
Manila, Philippines, 1000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00621322     History of Changes
Other Study ID Numbers: 110345
Study First Received: February 12, 2008
Last Updated: September 3, 2009
Health Authority: Philippines: Bureau of Food and Drugs

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 September 18, 2014