Last updated: 11/07/2018 02:56:12
Safety and immunogenicity study of GSK Biologicals tuberculosis vaccines (692342) to healthy adults
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
Number of subjects with solicited general symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 30-day (Days 0-29) post-vaccination period
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (from Day 0 up to Day 210)
Number of subjects with different biochemical and haematological levels
Timeframe: At Day 0
Number of subjects with different biochemical and haematological levels
Timeframe: At Day 7
Number of subjects with different biochemical and haematological levels
Timeframe: At Day 30
Number of subjects with different biochemical and haematological levels
Timeframe: At Day 37
Number of subjects with different biochemical and haematological levels
Timeframe: At Day 60
Secondary outcomes:
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
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
Anti-M72 specific antibody concentrations
Timeframe: At Day 0, 30, 60 and 210
Interventions:
Biological/vaccine: GSK Biologicals' AS01B adjuvant
Biological/vaccine: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) – Formulation 1
Biological/vaccine: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) – Formulation 2
Biological/vaccine: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) – Formulation 3
Biological/vaccine: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) – Formulation 4 - Dosage 1
Biological/vaccine: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) – Formulation 4 - Dosage 2
Enrollment:
180
Observational study model:
Not applicable
Primary completion date:
2009-03-04
Time perspective:
Not applicable
Clinical publications:
Montoya J et al. (2013) A randomized, controlled dose-finding Phase II study of the M72/AS01 candidate tuberculosis vaccine in healthy PPD-positive adults. J Clin Immunol. 33(8):1360–1375.
Medical condition
Tuberculosis
Product
SB692342
Collaborators
Not applicable
Study date(s)
April 2008 to April 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-03-04
Actual study completion date
2009-03-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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