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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

Page last updated: August 20, 2015

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