Tuberculosis
Conditions
Keywords
safety, vaccine, tuberculosis, CAF01, Ag85B-ESAT-6, prevention
Brief summary
The purpose of this study is to evaluate the safety profile of CAF01, administering 50 µg Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four groups of healthy volunteers, injecting two doses with two months interval.
Interventions
BIOLOGICAL50 µg Ag85B-ESAT-6 alone
0.5 mL solution for injection x 2 (2 months interval)
BIOLOGICAL50 µg Ag85B-ESAT-6 + 125/25 µg CAF01
0,5 mL suspension for injection x 2 (2 months interval)
BIOLOGICAL50 µg Ag85B-ESAT-6 + 313/63 µg CAF01
0.5 mL suspension for injection x 2 (2 months interval)
BIOLOGICAL50 µg Ag85B-ESAT-6 + 625/125 µg CAF01
0.5 mL suspension for injection x 2 (2 months interval)
Sponsors
Statens Serum Institut
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female or male adult between 18 and 55 years of age 2. Healthy according to medical history and medical examinations at screening 3. Signed informed consent 4. Prepared to grant authorized persons access to medical records 5. Likely to comply with instructions
Exclusion criteria
1. History of tuberculosis or known exposure to tuberculosis before (or expected during) the clinical trial 2. Positive Tuberculin Skin Test (TST) result at screening 3. Positive QuantiFERON® -TB Gold In-Tube test result according to the manufacturer's specifications at screening 4. BCG vaccination any time before entering the trial 5. History of or ongoing congenital or acquired immune deficiency, autoimmune disease or thyroid dysfunction 6. Disease affecting the lymphoid organs (Hodgkin's disease, lymphoma, leukaemia, sarcoidosis) 7. ANA-Titer, HBV, HCV, HIV sero-positive at screening 8. C-reactive protein level \> 50 mg/L at screening 9. Clinically significant abnormal laboratory test results at screening as assessed by the investigator 10. Severe ongoing viral or bacterial infection that might affect the cell mediated immune response 11. A condition in which repeated blood drawings pose more than minimal risk for the subject, such as haemophilia, other coagulation disorders, or significantly impaired venous access 12. Live vaccine vaccination (MMR, yellow fever, oral typhoid) within 3 months before the first vaccination 13. Immune modulating drugs administration (immunoglobulin, systemic corticosteroids, azathioprine, cyclosporine, infliximab, blood products or vaccines) within 3 months before the first vaccination 14. Known hypersensitivity to any of the vaccine components of the investigational vaccines 15. Intake of another clinical trial product/vaccine within 3 months before the first vaccination or participation in previous clinical trials with the Ag85B-ESAT-6 antigen 16. Pregnant according to a urine pregnancy test at inclusion 17. Females not willing to use contraceptives or breast feeding 18. Has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | one year after first vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity | one year after the first vaccination |
Countries
Netherlands
Outcome results
None listed