A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers (THYB-02)

Statens Serum Institut

Status and phase: Completed; Phase 1

Conditions: Tuberculosis

Treatments: Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)

Study type: Interventional

Funder types: Other

Identifiers

NCT00929396

THYB-02

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female between 18 and 55 years old
• BCG group: Known to be BCG-vaccinated over 2 years before, PPD positive (range 6-15 mm or any documented value between 6-15 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: Known to be treated for latent TB, PPDpositive (equal or over 10 mm or documented equal or over 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

• Granulomatous disease (by chest X-ray)
• 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
• Participation in other clinical trials
• Known hypersensitivity to any of the vaccine components
• Laboratory parameters outside of normal range judged by PI to be clinically relevant
• Pregnant women/planned pregnancy and/or breastfeeding within the trial period

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Latent TB infection group

Experimental group

Description:

The latent TB group will receive two injections of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart.

Treatment:

Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)

Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)

BCG vaccinated group

Experimental group

Description:

The BCG vaccinated group will receive two vaccinations of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart

Treatment:

Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)

Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)