Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00707967
First received: June 27, 2008
Last updated: April 14, 2011
Last verified: April 2011

June 27, 2008
April 14, 2011
June 2008
May 2009   (final data collection date for primary outcome measure)
  • 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: No ]
  • 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: 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: Prior to, one week and one month after each vaccination ] [ Designated as safety issue: No ]
  • 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. ]
  • 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. ]
  • Occurrence and relationship to vaccination of serious adverse events [ Time Frame: During the entire study period ]
  • Haematological and biochemical levels [ Time Frame: Prior to, one week and one month after each vaccination ]
Complete list of historical versions of study NCT00707967 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Antigen-specific antibody titres as measured by ELISA. [ Time Frame: Prior to each vaccination and one month and 6 months after the last dose ]
Not Provided
Not Provided
 
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine (692342) in HIV-positive Adults.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Tuberculosis (TB)
  • Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
    Intramuscular injection, 2 doses at 0, 1 month
  • Biological: Control vaccine with the adjuvant system.
    Intramuscular injection, 2 doses at 0, 1 month
  • Biological: Control vaccine with physiological saline
    Intramuscular injection, 2 doses at 0, 1 month
  • Experimental: Group A
    Subjects receiving the candidate vaccine
    Intervention: Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
  • Placebo Comparator: Group B
    Subjects receiving the adjuvant
    Intervention: Biological: Control vaccine with the adjuvant system.
  • Placebo Comparator: Group C
    Subjects receiving physiological saline
    Intervention: Biological: Control vaccine with physiological saline
Thacher EG, Cavassini M, Audran R, Thierry AC, Bollaerts A, Cohen J, Demoitié MA, Ejigu D, Mettens P, Moris P, Ofori-Anyinam O, Spertini F. Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine in HIV-infected adults on combination antiretroviral therapy: a phase I/II, randomized trial. AIDS. 2014 Jul 31;28(12):1769-81. doi: 10.1097/QAD.0000000000000343.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00707967
111517
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP