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

Phase 1

Completed

• Conditions: Tuberculosis
• Interventions: Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)

• Registration Number: NCT00929396
• Lead Sponsor: Statens Serum Institut

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2009-06-26
• Study First Submitted QC: 2009-06-26
• Study First Posted: 2009-06-29
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Latent TB infection group	50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)	The latent TB group will receive two injections of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart.
BCG vaccinated group	50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)	The BCG vaccinated group will receive two vaccinations of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Leiden University Medical Centre; 🇳🇱 Leiden, RC Leiden, Netherlands