Safety and Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Given at 0,1 Months to Healthy Adults

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Tuberculosis

Treatments: Biological: Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system; Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342; Biological: Control vaccine with the adjuvant system.; Biological: Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00397943

2005-004497-24 (EudraCT Number)

106227

108738 (Other Identifier)

106228 (Other Identifier)

108736 (Other Identifier)

Details and patient eligibility

About

This study will assess the safety and immunogenicity of 2 different formulations of tuberculosis vaccine GSK692342 in healthy adults.

Full description

The study is designed to have a vaccination phase (includes screening, 2 doses of vaccine 1 month apart and follow-up until 1 month post dose 2), which will be performed in an observer blinded manner. This will be followed by 3 years of follow-up which will continue in an open manner.

No new subjects will be recruited at the follow-up phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Enrollment: 110 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that they 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 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 entering into the study.
• Subjects must have PPD negative skin reactivity (0 mm induration 48 to 72 hours after PPD skin test administration).
• Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and differential, haemoglobin, platelet count and urinalysis.
• Seronegative for human immunodeficiency virus-1 and 2 (HIV 1/2) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies
• If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
• No evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past TB infection/disease) as confirmed by chest X-ray.

Exclusion criteria

• History of previous exposure to experimental products containing components of the experimental vaccine.
• 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 6 months prior to the first vaccine dose.
• Any chronic drug therapy to be continued during the study period. Vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies, SSRIs (e.g. Prozac, Zoloft, Paxil), NSAIDs (nonsteroidal anti-inflammatory drugs e.g. aspirin, ibuprofen), and acetaminophen are allowed.
• History of documented exposure to Mycobacterium tuberculosis.
• History of prior vaccination with experimental Mycobacterium tuberculosis vaccines.
• Administration of any immunoglobulins, any immunotherapy and/or any blood products within the 3 months preceding the first dose of study vaccination, or planned administrations during the study period.
• Participation in another experimental protocol during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition; or family history of congenital or hereditary immunodeficiency.
• History of hypersensitivity to vaccines or vaccine components
• 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.
• Volunteers with a personal history of autoimmune disease or who describe a first-degree relative with clearly documented autoimmune disease.
• History of any neurological disorders or seizures.
• History of chronic alcohol consumption and/or drug abuse.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects.
• Pregnant female, lactating female or female planning to become pregnant or planning to discontinue contraceptive precautions.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 5 patient groups, including a placebo group

M72/AS01B Group

Experimental group

Description:

Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.

Treatment:

Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342

M72/AS02A Group

Experimental group

Description:

Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.

Treatment:

Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342

Mtb72F/AS02A Group

Active Comparator group

Description:

Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.

Treatment:

Biological: Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system

Non-adjuvanted Group

Active Comparator group

Description:

Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.

Treatment:

Biological: Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline

Control Group

Placebo Comparator group

Description:

Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.

Treatment:

Biological: Control vaccine with the adjuvant system.