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

S

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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