Tuberculosis
Conditions
Keywords
safety, immunogenicity, adjuvanted TB subunit vaccine
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).
Interventions
BIOLOGICALAntigen (Ag85B-ESAT-6)
Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
BIOLOGICALAntigen (Ag85B-ESAT-6) with adjuvant (IC31)
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Sponsors
Statens Serum Institut
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed