Study to evaluate the efficacy of GlaxoSmithKline (GSK) Biologicals candidate tuberculosis (TB) vaccine in adults

Not Applicable

Recruiting

• Conditions: Tuberculosis

• Registration Number: PACTR201311000639144
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-06
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3506

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 (or thumb printed and witnessed) informed consent obtained from the subject.
-Baseline positive IGRA test result.
-Baseline negative HIV screen.
-Baseline negative clinical screening questionnaire and negative sputum sample for Pulmonary TB disease.
-Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination.
-Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
-Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 25 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 vaccination period and for 2 months after completion of the vaccination series.

Exclusion Criteria

-Current TB disease or history of TB disease and/or treatment for TB.
-Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
-Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each dose of vaccine.
-History of previous administration of experimental Mtb vaccines.
-Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.Inhaled and topical steroids are allowed.
-Any condition or illness or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine.
-Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
-Planned participation or participation in another experimental protocol during the study.
-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 product.
-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 or hypersensitivity likely to be exacerbated by any component of the vaccines.
-History of medically confirmed autoimmune disease.
-Pregnant or lactating female.
-Female planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination period and/or before 2 months after completion of the vaccination series.

Study & Design

• Study Type: Interventional
• Study Design: Not specified