Clinical trial NCT00621322: Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults
Official title: Dose Range Study Evaluating Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccines (692342) When Administered to Healthy Adults Aged 18 to 45 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tuberculosis
Keywords: Tuberculosis vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day (Days 0-29) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Day 0 up to Day 210)
measure: Number of Subjects With Different Biochemical and Haematological Levels
timeFrame: At Day 0
measure: Number of Subjects With Different Biochemical and Haematological Levels
timeFrame: At Day 7
measure: Number of Subjects With Different Biochemical and Haematological Levels
timeFrame: At Day 30
measure: Number of Subjects With Different Biochemical and Haematological Levels
timeFrame: At Day 37
measure: Number of Subjects With Different Biochemical and Haematological Levels
timeFrame: At Day 60
Secondary outcomes:
measure: Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines
timeFrame: At Day 0, 30, 60 and 210
measure: Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule
timeFrame: At Day 0, 30, 60 and 210
measure: Anti-M72 Specific Antibody Concentrations
timeFrame: At Day 0, 30, 60 and 210
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: