Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers
NCT ID: NCT00922363
Last Updated: 2013-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2009-10-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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50 µg Ag85B-ESAT-6 alone
50 µg Ag85B-ESAT-6 alone
0.5 mL solution for injection x 2 (2 months interval)
50 µg Ag85B-ESAT-6 + 125/25 µg CAF01
50 µg Ag85B-ESAT-6 + 125/25 µg CAF01
0,5 mL suspension for injection x 2 (2 months interval)
50 µg Ag85B-ESAT-6 + 313/63 µg CAF01
50 µg Ag85B-ESAT-6 + 313/63 µg CAF01
0.5 mL suspension for injection x 2 (2 months interval)
50 µg Ag85B-ESAT-6 + 625/125 µg CAF01
50 µg Ag85B-ESAT-6 + 625/125 µg CAF01
0.5 mL suspension for injection x 2 (2 months interval)
Interventions
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50 µg Ag85B-ESAT-6 alone
0.5 mL solution for injection x 2 (2 months interval)
50 µg Ag85B-ESAT-6 + 125/25 µg CAF01
0,5 mL suspension for injection x 2 (2 months interval)
50 µg Ag85B-ESAT-6 + 313/63 µg CAF01
0.5 mL suspension for injection x 2 (2 months interval)
50 µg Ag85B-ESAT-6 + 625/125 µg CAF01
0.5 mL suspension for injection x 2 (2 months interval)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
55 Years
ALL
Yes
Sponsors
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Statens Serum Institut
OTHER
Responsible Party
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Locations
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Department of infectious diseases, C5-P, LUMC
Leiden, , Netherlands
Countries
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Other Identifiers
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ACAF01-01
Identifier Type: -
Identifier Source: org_study_id
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