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

Tuberculosis Clinical Trial

— THYB-02  

Official title:

A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)Administered in PPD Positive Volunteers at 0 and 2 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929396
• Other study ID #: THYB-02
• Status: Completed
• Phase: Phase 1
• First received: June 26, 2009
• Last updated: January 18, 2013
• Start date: September 2007
• Est. completion date: June 2009

Study information

• Verified date: January 2013
• Source: Statens Serum Institut
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and SportNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Biological:
• 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
o,5 mL suspension for injection x 2 with 2 months interval
• 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
o,5 mL suspension for injection x 2 with 2 months interval

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Centre	Leiden	RC Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Statens Serum Institut

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical examination. Local adverse events.Systemic adverse events. Laboratory safety tests including urine safety tests.		From first vaccination until 8 months after the first vaccination	Yes
Secondary	Detection by ELISPOT of IFNgamma spot-forming cells in PBMCs. Detection by ELISA of IFNgamma production in supernatants of PBMC. Detection by ELISA of IgG antibodies in serum/plasma. Detection by Elisa of TNFalfa and IFNgamma in serum		From first vaccination until 8 months after first vaccination	No