A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) (THYB-03)

Statens Serum Institut

Status and phase: Completed; Phase 1

Conditions: Tuberculosis

Treatments: Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31); Biological: Antigen (Ag85B-ESAT-6)

Study type: Interventional

Funder types: Other

Identifiers

NCT01049282

THYB-03

Details and patient eligibility

About

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.

Full 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).

Enrollment: 39 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 4 patient groups

12 TST negative volunteers antigen only

Experimental group

Treatment:

Biological: Antigen (Ag85B-ESAT-6)

12 TST negative volunteers

Experimental group

Treatment:

Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)

12 BCG vaccinated volunteers

Experimental group

Treatment:

Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)

12 with Latent TB infection >= 2 years ago

Experimental group

Treatment:

Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)