Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tuberculosis
Intervention: GSK Biologicals' investigational TB vaccine GSK 692342 (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: Evaluation of the Kinetics of mRNA Expression After Two Doses of GSK Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342 in Healthy Adults
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Description of (messenger) Ribonucleic Acid (mRNA) signatures in Peripheral Blood Mononuclear cell(s) (PBMCs)Description of (messenger) Ribonucleic Acid (mRNA) signatures in Peripheral Blood Mononuclear cell(s) (PBMCs) Description of (messenger) Ribonucleic Acid (mRNA) signatures in Peripheral Blood Mononuclear cell(s) (PBMCs) Description of mRNA signatures in whole blood Description of mRNA signatures in whole blood Description of mRNA signatures in whole blood Description of mRNA signatures in whole blood Description of mRNA signatures in whole blood Description of mRNA signatures in whole blood Description of mRNA signatures in whole blood Evaluation of Interferon gamma (IFN-γ) secretion in serum Evaluation of Interferon gamma (IFN-γ) secretion in serum Evaluation of Interferon gamma (IFN-γ) secretion in serum Evaluation of Interferon gamma ( IFN-γ) secretion in serum Evaluation of Interferon gamma (IFN-γ ) secretion in serum Evaluation of Interferon gamma (IFN -γ) secretion in serum Evaluation of cell mediated immunogenicity (CMI) responses with respect to components of the study vaccine Evaluation of cell mediated immunogenicity (CMI) responses with respect to components of the study vaccine Occurrence of Serious Adverse Events (SAEs) Occurrence of solicited local and general adverse events (AEs) Occurrence of unsolicited AEs Occurrence of all potential Immune-Mediated Disease(s) (pIMDs)
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Investigational Site, Gent 9000, Belgium
Additional Information
Starting date: August 2012
Last updated: November 13, 2014
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