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

NCT ID: NCT00397943

Last Updated: 2019-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-15
• Study Completion Date: 2009-12-01

Brief Summary

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

Detailed 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.

Conditions

Tuberculosis

Study Design

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

Study Groups

M72/AS01B Group

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.

Group Type: EXPERIMENTAL

GSK's candidate Mycobacterium tuberculosis vaccine 692342

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses at 0, 1 month

M72/AS02A Group

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.

Group Type: EXPERIMENTAL

GSK's candidate Mycobacterium tuberculosis vaccine 692342

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses at 0, 1 month

Mtb72F/AS02A Group

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.

Group Type: ACTIVE_COMPARATOR

Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses at 0, 1 month

Non-adjuvanted Group

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.

Group Type: ACTIVE_COMPARATOR

Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses at 0, 1 month

Control Group

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.

Group Type: PLACEBO_COMPARATOR

Control vaccine with the adjuvant system.

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses at 0, 1 month

Interventions

GSK's candidate Mycobacterium tuberculosis vaccine 692342

Intramuscular injection, 2 doses at 0, 1 month

Intervention Type: BIOLOGICAL

Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system

Intramuscular injection, 2 doses at 0, 1 month

Intervention Type: BIOLOGICAL

Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline

Intramuscular injection, 2 doses at 0, 1 month

Intervention Type: BIOLOGICAL

Control vaccine with the adjuvant system.

Intramuscular injection, 2 doses at 0, 1 month

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 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

Ghent, , Belgium

Countries

Belgium

References

Leroux-Roels I, Forgus S, De Boever F, Clement F, Demoitie MA, Mettens P, Moris P, Ledent E, Leroux-Roels G, Ofori-Anyinam O; M72 Study Group. Improved CD4(+) T cell responses to Mycobacterium tuberculosis in PPD-negative adults by M72/AS01 as compared to the M72/AS02 and Mtb72F/AS02 tuberculosis candidate vaccine formulations: a randomized trial. Vaccine. 2013 Apr 19;31(17):2196-206. doi: 10.1016/j.vaccine.2012.05.035. Epub 2012 May 27.

Reference Type: BACKGROUND

PMID: 22643213 (View on PubMed)

Moris P, Bellanger A, Ofori-Anyinam O, Jongert E, Yarzabal Rodriguez JP, Janssens M. Whole blood can be used as an alternative to isolated peripheral blood mononuclear cells to measure in vitro specific T-cell responses in human samples. J Immunol Methods. 2021 May;492:112940. doi: 10.1016/j.jim.2020.112940. Epub 2021 Jan 23.

Reference Type: DERIVED

PMID: 33493551 (View on PubMed)

Other Identifiers

106228

Identifier Type: OTHER

Identifier Source: secondary_id

108736

Identifier Type: OTHER

Identifier Source: secondary_id

108738

Identifier Type: OTHER

Identifier Source: secondary_id

2005-004497-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

106227

Identifier Type: -

Identifier Source: org_study_id