Study in healthy adults to evaluate gene activation after vaccination with GlaxoSmithKline (GSK) Biologicals’ candidate tuberculosis (TB) vaccine GSK 692342

Phase 1

Active, not recruiting

• Conditions: Healthy volunteers (Prevention of tuberculosis [TB] disease in children, adolescents and adults); Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-002541-37-BE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-19
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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 (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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified