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
Study complete
Study complete
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:
Enrollment:
180
Primary completion date:
2009-03-04
Observational study model:
Not applicable
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
Study complete
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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