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Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-Positive Adults.
This study is ongoing, but not recruiting participants.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00707967
  Purpose

This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.


Condition Intervention Phase
Tuberculosis (TB)
Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Biological: Control vaccine with the adjuvant system.
Biological: Control vaccine with physiological saline
Phase II

MedlinePlus related topics: AIDS Tuberculosis
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title: Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine (692342) in HIV-Positive Adults.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence, intensity and relationship to vaccination of solicited local and general adverse events [ Time Frame: During the 7-day follow-up period following vaccination after each vaccine dose. ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity and relationship to vaccination of unsolicited adverse events. [ Time Frame: During the 30-day follow-up period following vaccination after each vaccine dose. ] [ Designated as safety issue: Yes ]
  • Occurrence and relationship to vaccination of serious adverse events [ Time Frame: During the entire study period ] [ Designated as safety issue: Yes ]
  • Haematological and biochemical levels [ Time Frame: Prior to, one week and one month after each vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of cytokine/activation marker expression by antigen-specific CD4+/CD8+ T cells by means of in vitro flow cytometry. [ Time Frame: Prior to each vaccination and one month and 6 months after the last dose ] [ Designated as safety issue: No ]
  • Antigen-specific antibody titres as measured by ELISA. [ Time Frame: Prior to each vaccination and one month and 6 months after the last dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group B: Placebo Comparator
Subjects receiving the adjuvant
Biological: Control vaccine with the adjuvant system.
Intramuscular injection, 2 doses at 0, 1 month
Group C: Placebo Comparator
Subjects receiving physiological saline
Biological: Control vaccine with physiological saline
Intramuscular injection, 2 doses at 0, 1 month
Group A: Experimental
Subjects receiving the candidate vaccine
Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Intramuscular injection, 2 doses at 0, 1 month

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, 18 and 50 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject prior to any study procedure.
  • Subjects must be HIV-positive and must have:

    • received Highly Active Antiretroviral therapy for a minimum of 12 consecutive months prior to screening
    • documented suppressed HIV-1 RNA levels following HAART-treatment.
    • a protocol defined CD4+ T cell count at screening
  • If the subject is female, she must be of non-childbearing potential, or 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 vaccination.
  • Clinically acceptable laboratory values prior to randomisation as determined by the Investigator.
  • No evidence of TB disease with no pulmonary pathology as confirmed by chest X-ray.
  • No history of extrapulmonary TB.
  • No history of chemotherapy for TB.

Exclusion Criteria:

  • Any change in antiretroviral drug regimen within 12 weeks prior to screening.
  • 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.
  • 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.
  • History of previous administration of experimental Mycobacterium tuberculosis vaccines.
  • History of previous exposure to experimental products containing components of the experimental vaccine.
  • Chronic administration of immunosuppressive or other immune-modifying drugs within six months prior to the first vaccine dose.
  • 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.
  • Any condition or illness (acute, chronic or history) or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine.
  • Planned participation or participation in another experimental protocol during the study period.
  • A family history of congenital or hereditary immunodeficiency. •Any chronic drug therapy, other than HAART or prophylaxis for opportunistic HIV-related infections to be continued during the study period. Vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies and SSRIs are allowed.
  • Subjects taking any of the following medication: systemic steroids, interleukins, systemic interferons or systemic chemotherapy.
  • History of allergic reactions or anaphylaxis to any vaccine.
  • 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 Investigator's opinion would put the subject at risk.
  • Pregnant female, lactating female or female planning to become pregnant or stop contraception.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707967

Locations
Switzerland
GSK Investigational Site
Lausanne, Switzerland, 1011
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: 111517
Study First Received: June 27, 2008
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00707967  
Health Authority: Switzerland: Swissmedic

Keywords provided by GlaxoSmithKline:
Tuberculosis vaccine

Study placed in the following topic categories:
Bacterial Infections
Gram-Positive Bacterial Infections
HIV Seropositivity
HIV Infections
Acquired Immunodeficiency Syndrome
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009