Status:
COMPLETED
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
Lead Sponsor:
Statens Serum Institut
Conditions:
Tuberculosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 v...
Eligibility Criteria
Inclusion
- Female or male adult between 18 and 55 years of age
- Healthy according to medical history and medical examinations at screening
- Signed informed consent
- Prepared to grant authorized persons access to medical records
- Likely to comply with instructions
Exclusion
- History of tuberculosis or known exposure to tuberculosis before (or expected during) the clinical trial
- Positive Tuberculin Skin Test (TST) result at screening
- Positive QuantiFERON® -TB Gold In-Tube test result according to the manufacturer's specifications at screening
- BCG vaccination any time before entering the trial
- History of or ongoing congenital or acquired immune deficiency, autoimmune disease or thyroid dysfunction
- Disease affecting the lymphoid organs (Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
- ANA-Titer, HBV, HCV, HIV sero-positive at screening
- C-reactive protein level \> 50 mg/L at screening
- Clinically significant abnormal laboratory test results at screening as assessed by the investigator
- Severe ongoing viral or bacterial infection that might affect the cell mediated immune response
- 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
- Live vaccine vaccination (MMR, yellow fever, oral typhoid) within 3 months before the first vaccination
- Immune modulating drugs administration (immunoglobulin, systemic corticosteroids, azathioprine, cyclosporine, infliximab, blood products or vaccines) within 3 months before the first vaccination
- Known hypersensitivity to any of the vaccine components of the investigational vaccines
- 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
- Pregnant according to a urine pregnancy test at inclusion
- Females not willing to use contraceptives or breast feeding
- Has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00922363
Start Date
October 1 2009
End Date
October 1 2011
Last Update
January 21 2013
Active Locations (1)
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1
Department of infectious diseases, C5-P, LUMC
Leiden, Netherlands, NL-2300 RC