Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342

This study has been completed.
Sponsor:
Collaborator:
Aeras
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01669096
First received: August 16, 2012
Last updated: November 27, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to assess the safety and immunogenicity of two doses of the TB vaccine administered according to a 0, 1 month schedule. In, addition, blood samples collected at different time points after vaccination will be analysed to see when exactly genes are activated by the vaccine using an assay called mRNA expression profiling. The different methods for mRNA expression profiling using whole blood samples versus Peripheral Blood Mononuclear cell(s) (PBMCs), will also be compared.


Condition Intervention Phase
Tuberculosis
Biological: GSK Biologicals' investigational TB vaccine GSK 692342
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of the Kinetics of mRNA Expression After Two Doses of GSK Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342 in Healthy Adults

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Evaluation of Interferon gamma (IFN-γ) secretion in serum [ Time Frame: Prior to dose 1 (Day 0) ] [ Designated as safety issue: No ]
  • Evaluation of Interferon gamma (IFN-γ) secretion in serum [ Time Frame: Post dose 1 (Day 7) ] [ Designated as safety issue: No ]
  • Evaluation of Interferon gamma (IFN-γ) secretion in serum [ Time Frame: Post dose 1 (Day 30) ] [ Designated as safety issue: No ]
  • Evaluation of Interferon gamma ( IFN-γ) secretion in serum [ Time Frame: Post dose 2 (Day 37) ] [ Designated as safety issue: No ]
  • Evaluation of Interferon gamma (IFN-γ ) secretion in serum [ Time Frame: Post dose 2 (Day 60) ] [ Designated as safety issue: No ]
  • Evaluation of Interferon gamma (IFN -γ) secretion in serum [ Time Frame: Post dose 2 (Day 210) ] [ Designated as safety issue: No ]
  • Evaluation of cell mediated immunogenicity (CMI) responses with respect to components of the study vaccine [ Time Frame: Prior to dose 1 (Day 0) ] [ Designated as safety issue: No ]
  • Evaluation of cell mediated immunogenicity (CMI) responses with respect to components of the study vaccine [ Time Frame: Post dose 2 (Day 60) ] [ Designated as safety issue: No ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (Day 0 to Month 7) ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general adverse events (AEs) [ Time Frame: During the 7 day follow-up period following each vaccination (day of vaccination and 6 subsequent days) ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited AEs [ Time Frame: During the 30 day follow-up period following each vaccination (day of vaccination and 29 subsequent days) ] [ Designated as safety issue: No ]
  • Occurrence of all potential Immune-Mediated Disease(s) (pIMDs) [ Time Frame: During the entire study period (Day 0 to Month 7) ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2012
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TB Group
Subjects will receive two doses of TB vaccine
Biological: GSK Biologicals' investigational TB vaccine GSK 692342
2 doses administered intramuscularly according to a 0, 1 month schedule (Day 0 and Day 30), in the deltoid region of the arm

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, 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 obtaining informed consent.
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Known BCG vaccination or presence of a BCG scar.
  • Seronegative for human immunodeficiency virus-1.
  • Female of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of screening and the day of first vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

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 (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent). Inhaled and topical steroids are allowed.
  • Administration of long-acting immune-modifying drugs starting 2 years before the first dose and planned administration during the study.
  • Planned administration/administration of a vaccine/product not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine and ending at the last study visit.
  • 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 vaccine/product (pharmaceutical product or device).
  • History of TB disease.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • QuantiFERON® TB Gold positive test result.
  • History of medically confirmed autoimmune disease.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • History of any reaction of hypersensitivity likely to be exacerbated by any component of the vaccine.
  • 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: NCT01669096

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Aeras
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01669096     History of Changes
Other Study ID Numbers: 116777, 2012-002541-37
Study First Received: August 16, 2012
Last Updated: November 27, 2013
Health Authority: Belgium: Ministry of Health

Keywords provided by GlaxoSmithKline:
adults
Tuberculosis vaccine
HIV negative
healthy
mRNA expression

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 16, 2014