A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered in Different Antigen/Adjuvant Formulations in TST Negative and TST Positive Volunteers at 0 and 2 Months
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Statens Serum Institut
- Enrollment
- 39
- Primary Endpoint
- Safety on Physical examination , and Laboratory safety tests of hematology clinical chemistry
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
12 TST negative volunteers antigen only
Intervention: Antigen (Ag85B-ESAT-6) (Biological)
12 TST negative volunteers
Intervention: Antigen (Ag85B-ESAT-6) with adjuvant (IC31) (Biological)
12 BCG vaccinated volunteers
Intervention: Antigen (Ag85B-ESAT-6) with adjuvant (IC31) (Biological)
12 with Latent TB infection >= 2 years ago
Intervention: Antigen (Ag85B-ESAT-6) with adjuvant (IC31) (Biological)
Outcomes
Primary Outcomes
Safety on Physical examination , and Laboratory safety tests of hematology clinical chemistry
Time Frame: 12 visits in a total of 224 days duratiion from the day of first vaccinantion
Secondary Outcomes
- 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)