A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine (THYB-01)

Statens Serum Institut

Status and phase: Completed; Phase 1

Conditions: Tuberculosis

Treatments: Biological: 50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a; Biological: 50 microgram antigen (Ag85B + ESAT-6); Biological: 50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a

Study type: Interventional

Funder types: Other

Identifiers

NCT01003093

THYB-01

Eudract number: TEST-001599-14

Details and patient eligibility

About

The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB

Enrollment: 36 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male
• Healthy based on medical examination/history at the inclusion
• Age between 18 and 55 years
• Signed informed consent
• Prepared to grant authorized persons access to the medical records
• The volunteer is likely to comply with instructions

Exclusion criteria

• Known exposure to TB before (or expected during) the trial
• Prior BCG vaccination
• Granulomatous disease (by chest X-ray, autoimmune screen)
• Vaccinated with live vaccine 3 months before first vaccination
• Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination
• HBV, HCV or HIV sero-positive (HBsAg, HBsAb, HBc total and IgM ab and HCV, HIV-1 and HIV2 ab)
• Participation in other clinical trials
• Positive Mantoux or QuantiFERON-TB Gold
• Known hypersensitivity to any of the vaccine components
• Laboratory parameters outside of normal ranges considered clinically relevant

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Antigen group + high adjuvans

Experimental group

Description:

The antigen group + high adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (500 nmol KLK + 20 nmol ODN1a) two months apart.

Treatment:

Biological: 50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a

Antigen group

Experimental group

Description:

The antigen group received two injections of antigen (Ag85B + ESAT-6) two months apart.

Treatment:

Biological: 50 microgram antigen (Ag85B + ESAT-6)

Antigen + low adjuvans group

Experimental group

Description:

The antigen group + low adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (100 nmol KLK + 4 nmol ODN1a) two months apart.

Treatment:

Biological: 50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a