A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)
- Conditions
- Tuberculosis
- Interventions
- Biological: Antigen (Ag85B-ESAT-6)Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
- Registration Number
- NCT01049282
- Lead Sponsor
- Statens Serum Institut
- Brief Summary
The study has the following objectives:
Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective To determine the immunogenicity profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months.
- Detailed Description
Number of trial subjects=48 Investigational product=Ag85B - ESAT-6 + IC31 Dosage Group 1: TST negative, 50 µg antigen Group 2: TST negative, 50 µg antigen + fixed adjuvant Group 3: BCG vaccinated, 50 µg antigen + fixed adjuvant Group 4 : Latent TB, 50 µg antigen + fixed adjuvant Dosage volume 0.5 ml Administration Intramuscularly into deltoid muscle, alternate arms at day 0 (right) and day 56 (left).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 39
- Male between 18 and 40 years old
- TST negative groups: TST- and negative QuantiFERON-TB Gold In tube test
- BCG group: known to be BCG-vaccinated > 2 years before(scar, vaccination card), TST+ (> 6 or any documented value > 6 mm on medical file in the past), with no active, chronic or past TB disease as confirmed by chest X ray, negative QuantiFERON-TB Gold In Tube test and negative 6-day lymphocyte tests.
- Infection group: latent TB, TST+ ( = or > 10 mm or documented = or > 10 mm positive on medical file in the past), previously TB infected but with no active disease confirmed by chest X ray, may have received chemoprophylaxis but with no TB treatment/chemoprophylaxis within the preceding 2 years, positive QuantiFERON-TB Gold In Tube test and/or positive 6-day lymphocyte test.
- Healthy based on medical examination/history at the inclusion
- Signed informed consent
- Prepared to grant authorized persons access to the medical records
- The volunteer is likely to comply with instructions
- Confirmed active TB based on clinical evaluation(history, physical findings and investigations)
- Vaccinated with any vaccine 3 months before first vaccination
- Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins)
- HBV, HCV or HIV sero-positive
- Participation in other clinical trials
- Known hypersensitivity to any of the vaccine components
- Laboratory parameters outside of normal range considered clinically relevant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 12 TST negative volunteers antigen only Antigen (Ag85B-ESAT-6) - 12 TST negative volunteers Antigen (Ag85B-ESAT-6) with adjuvant (IC31) - 12 with Latent TB infection >= 2 years ago Antigen (Ag85B-ESAT-6) with adjuvant (IC31) - 12 BCG vaccinated volunteers Antigen (Ag85B-ESAT-6) with adjuvant (IC31) -
- Primary Outcome Measures
Name Time Method Safety on Physical examination , and Laboratory safety tests of hematology clinical chemistry 12 visits in a total of 224 days duratiion from the day of first vaccinantion
- Secondary Outcome Measures
Name Time Method Immunogenicity assessment by: A.Detection of IFN gama production after stimulation with Ag85B, ESAT-6 and H1. B.Detection of IgG antibodies to recombinant proteins Ag85B, ESAT-6 and H1 in serum/plasma. 12 visits in a total of 224 days duratiion from the day of first vaccinantion