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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine (692342) in HIV-positive Adults.

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 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 ]

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 ]

Enrollment: 37
Study Start Date: June 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects receiving the candidate vaccine
Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Intramuscular injection, 2 doses at 0, 1 month
Placebo Comparator: Group B
Subjects receiving the adjuvant
Biological: Control vaccine with the adjuvant system.
Intramuscular injection, 2 doses at 0, 1 month
Placebo Comparator: Group C
Subjects receiving physiological saline
Biological: Control vaccine with physiological saline
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
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: NCT00707967

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

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00707967     History of Changes
Other Study ID Numbers: 111517
Study First Received: June 27, 2008
Last Updated: April 14, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by GlaxoSmithKline:
Tuberculosis vaccine

Additional relevant MeSH terms:
HIV Seropositivity
Tuberculosis
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 26, 2014