Vaccination against tuberculosis (TB) in adults aged 18 to 59 years with TB disease. MedDRA version: 16.1 Level: LLT Classification code 10045023 Term: Tuberculosis prophylaxis System Organ Class: 100000004865
Conditions
Interventions
Product Name: Recombinant Mycobacterium
Product Code: M72/AS01E
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: M72 antigen
Other descriptive name: M72 antigen
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who the investigator believes can and will comply with the requirements of the protocol. A male or female between, and including, 18 and 59 years of age at the time of the first vaccination. Written informed consent obtained from the subject. Female subjects 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 vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Seronegative for HIV- 1 and –2 antibodies. No history of or current extrapulmonary tuberculosis . Additionally, based on medical history, Subjects in the TB-naive cohort must have no active pulmonary disease as indicated by chest X-ray, have no signs and symptoms of TB and have no history of chemoprophylaxis or treatment for TB. Subjects in the TB-treated cohort must have a history of successful treatment for pulmonary TB (completed at least 1 year prior to vaccination) and have no active pulmonary disease on chest X-ray. Subjects in the TB-treatment cohort must have documented treatment for pulmonary TB (smear- or culture confirmed) ongoing for 2-4 months prior to vaccination. 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 240 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 other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine. 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, which in the opinion of the investigator could adversely interfere with the vaccine. History of previous administration of experimental TB vaccines. History of previous exposure to components of the investigational vaccine within 30 days preceding the first dose of study vaccine. 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. Planned participation or participation in another experimental protocol during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. History of chronic alcohol 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 discontinue contraceptive precautions during the active phase of the study (from study start till 2 months after dose 2). Additionally, for the TB naïve and TB treated cohorts: Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or laboratory screening tests. Additionally, for the TB treatment cohort: Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or laboratory screening tests; individuals with grade 3 levels will be excluded, and failure to convert while on anti-TB treatment at the end of the second month of anti-TB therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and reactogenicity of GSK Biologicals’ candidate TB vaccine M72/AS01E in the study population.;Secondary Objective: To assess the immunogenicity of GSK Biologicals’ candidate TB vaccine M72/AS01E in the study population.;Primary end point(s): Occurrence of solicited adverse events (AEs). Occurrence of unsolicited adverse events (AEs). Occurrence of serious adverse events (SAEs) ;Timepoint(s) of evaluation of this end point: For solicited AEs:During the 7-day follow-up period following vaccination (day of vaccination and 6 subsequent days after each vaccine dose). For unsolicited AEs:During the 30-day follow-up period following vaccination (day of vaccination and 29 subsequent days after each vaccine dose). For SAEs:From screening (between Day -59 and Day -3) up to Day 210. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cell mediated immunogenicity (CMI) with respect to components of the study vaccine as determined by the frequency of M72-specific CD4+/CD8+ T cells per million cells identified after in vitro stimulation, as expressing 2 or more immune markers, and explored by the frequency of M72-specific CD4+/CD8+ T cells per million cells characterized descriptively after in vitro stimulation, as expressing any combination of the different immune markers. Humoral immunogenicity with respect to components of the study vaccine as determined by the M72-specific antibody concentrations as measured by ELISA and determined by the seropositivity rates as measured by ELISA.;Timepoint(s) of evaluation of this end point: For CMI: Prior to dose 1 (Day 0), post dose 1 (Days 7 and 30) and post dose 2 (Days 37, 60 and 210). For Humoral responses:Prior to dose 1 (Day 0), post dose 1 (Day 30) and post dose 2 (Days 60 and 210) | — |
Countries
Estonia, Taiwan
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed