Vaccination against tuberculosis
Conditions
Interventions
Product Name: M72/AS02A
Pharmaceutical Form: Powder and solvent for solution for injection
Current Sponsor code: M72
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number:
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • A male or female between, and including, 18 and 50 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 entering into the study. • Subjects must have PPD negative skin reactivity (0 mm induration 48 to72 hours after PPD skin test administration). • Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and differential, haemoglobin, platelet count and urinalysis. • Seronegative for human immunodeficiency virus 1 and 2 (HIV 1/2) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies. • If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. • No evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past TB infection/disease) as confirmed by chest X-ray. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • History of previous exposure to experimental products containing AS02A, AS01B or related products containing MPL and QS21. • 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) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, > = 0.5 mg/kg/day. Inhaled and topical steroids are allowed). • 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, SSRIs (e.g. Prozac, Zoloft, Paxil), NSAIDs (nonsteroidal anti-inflammatory drugs e.g. aspirin, ibuprofen), and acetaminophen. • History of previous administration of experimental Mycobacterium tuberculosis vaccines • History of documented work related or close personal contact (same household) exposure to persons infected with Mycobacterium tuberculosis • 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. • Participation in another experimental protocol during the study period. • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required). • 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. • Volunteers with a personal history of autoimmune disease or who describe a first-degree relative with clearly documented autoimmune disease • History of any neurologic disorders or seizures. • History of chronic alcohol consumption and/or drug abuse. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. • Major congenital defects. • Pregnant or lactating female. • Female planning to become pregnant or planning to discontinue contraceptive precautions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and reactogenicity of GSK Biologicals’ candidate M72/AS02A and M72/AS01B tuberculosis vaccines and the comparator vaccines (Mtb72F/AS02A, M72/Saline and AS01B) when given according to a 0, 1 month schedule in healthy PPD-negative adults aged 18 to 50 years.;Secondary Objective: • To evaluate the humoral immunogenicity as measured by ELISA for the candidate tuberculosis vaccines (M72/AS02A and M72/AS01B) and the comparator vaccines (Mtb72F/AS02A, M72/Saline and AS01B). • To evaluate cellular mediated immune response for the candidate tuberculosis vaccines (M72/AS02A and M72/AS01B) and the comparator vaccines (Mtb72F/AS02A, M72/Saline and AS01B) ? in terms of Th1 cytokine expression of antigen-specific CD4/CD8 T cells, as determined by flow cytometry after in-vitro stimulation of frozen PBMCs. ? in terms of Th1 cytokine production in serum as determined by ELISA. ;Primary end point(s): Safety and reactogenicity as determined by • Occurrence, intensity and relationship to vaccination of solicited local and general symptoms during the 7-day follow-up period following vaccination (day of vaccination and 6 subsequent days) after each vaccine dose in each group. • Occurrence, intensity and relationship to vaccination of unsolicited symptoms during the 30-day follow-up period following vaccination (day of vaccination and 29 subsequent days) after each vaccine dose in each group. • Occurrence and relationship to vaccination of serious adverse events during the entire study period in each group. • Haematological and biochemical levels, at Days 0, 1, 7, 30, 31, 37 and 60 in each group. | — |
Countries
Belgium
Outcome results
None listed