Healthy volunteers (Prevention of tuberculosis [TB] disease in children, adolescents and adults)
Conditions
Interventions
Product Name: Recombinant Mycobacterium tuberculosis vaccine
Product Code: M72/AS01E
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: M72 antigen
Current Sponsor
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who, in the opinion of the investigator, 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 obtaining informed consent. Written informed consent obtained from the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Known BCG vaccination or presence of a BCG scar. Seronegative for human immunodeficiency virus-1. Female of non-childbearing potential may be enrolled in the study Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of screening and the day of first vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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 (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone (Inhaled and topical steroids are allowed). Administration of long-acting immune-modifying drugs starting 2 years before the first dose and planned administration during the study. Planned administration/administration of a vaccine/product not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine and ending at the last study visit. 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 vaccine/product (pharmaceutical product or device). History of TB disease. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. QuantiFERON® TB Gold positive test result. History of medically confirmed autoimmune disease. Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. History of any reaction of hypersensitivity likely to be exacerbated by any component of the vaccine. Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and reactogenicity of two doses of the TB candidate vaccine. To assess the immunogenicity of two doses of the TB candidate vaccine.;Secondary Objective: Not Applicable;Primary end point(s): Evaluation of Interferon gamma (IFN-gamma) secretion in serum; determined by IFN-gamma-specific antibody concentrations as measured by ELISA. Evaluation of cell mediated immunogenicity (CMI) responses with respect to components of the study vaccine; determined by the frequency of M72-specific CD4+/CD8+ T cells per million cells identified after in vitro stimulation, as expressing at least 2 immune markers among IL-2, TNF-alpha, IFN-gamma, CD40L, IL-13 and IL-17 and determined by the frequency of M72-specific CD4+/CD8+ T cells per million cells identified after in vitro stimulation, as expressing any combination of immune markers among IL-2, TNF-alpha, IFN-gamma, CD40L, IL-13 and IL-17. Occurence of Serious Adverse Events (SAEs) Occurence of solicited local and general Adverse Events (AEs). Occurence of unsolicited Adverse events (AEs) ;Timepoint(s) of evaluation of this end point: INF-gamma secretion in serum:Prior to dose 1 (Day 0), post dose 1 (Day 30), post dose 2 (Days 31, 37, 40, 44 and 47). Cell mediated immunogenicity:Prior to dose 1 (Day 0) and post dose 2 (Day 60). SAEs: During the entire study period (Day 0 to Month 7). Solicited local and general adverse events: During the 7 day follow-up period following each vaccination (day of vaccination and 6 subsequent days). Unsolicited AEs: During the 30 day follow-up period following each vaccination (day of vaccination and 29 subsequent days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Belgium
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed