Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults

NCT ID: NCT00621322

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-03
• Study Completion Date: 2009-04-03

Brief Summary

This observer blind study will assess the safety and immunogenicity of different formulations of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control Group

Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.

Group Type: PLACEBO_COMPARATOR

GSK Biologicals' AS01B adjuvant

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

GSK692342_F1 Group

Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.

Group Type: ACTIVE_COMPARATOR

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

GSK692342_F2 Group

Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.

Group Type: EXPERIMENTAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

GSK692342_F3 Group

Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.

Group Type: EXPERIMENTAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

GSK692342_F4D1 Group

Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.

Group Type: EXPERIMENTAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

GSK692342_F4D2 Group

Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.

Group Type: EXPERIMENTAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

Interventions

GSK Biologicals' AS01B adjuvant

Intramuscular injection, 2 doses

Intervention Type: BIOLOGICAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1

Intramuscular injection, 2 doses

Intervention Type: BIOLOGICAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2

Intramuscular injection, 2 doses

Intervention Type: BIOLOGICAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3

Intramuscular injection, 2 doses

Intervention Type: BIOLOGICAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1

Intramuscular injection, 2 doses

Intervention Type: BIOLOGICAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2

Intramuscular injection, 2 doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 18 and 45 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject prior to any study procedure.
• Free of obvious health problems as established by medical history and clinical examination before enrolment into the study.
• If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
• No evidence of pulmonary pathology as confirmed by chest X-ray.
• No history of extrapulmonary TB.
• Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and urinalysis.
• Seronegative for human immunodeficiency virus-1 and -2 (HIV-1 and -2) antibodies.
• Subjects must have a PPD positive skin reactivity 48 to 72 hours after PPD skin test administration.

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 of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies and SSRIs.
• History of previous administration of experimental Mycobacterium tuberculosis vaccines.
• History of previous exposure to experimental products containing MPL or QS21.
• Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the first dose of study vaccination, or planned administrations during the study period.
• 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 (pharmaceutical product or device).
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• A family history (first generation) of congenital or hereditary immunodeficiency.
• History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
• History of any neurological disorders or seizures.
• History of allergic reactions or anaphylaxis to previous immunisations.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• History of chronic alcohol consumption and/or drug abuse.
• Major congenital defects.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Manila, , Philippines

Countries

Philippines

Other Identifiers

110345

Identifier Type: -

Identifier Source: org_study_id