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

Phase 1

Completed

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

• Registration Number: NCT01003093
• 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 in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2008-03
• Study Completion: 2008-06
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antigen group + high adjuvans	50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a	The antigen group + high adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (500 nmol KLK + 20 nmol ODN1a) two months apart.
Antigen group	50 microgram antigen (Ag85B + ESAT-6)	The antigen group received two injections of antigen (Ag85B + ESAT-6) two months apart.
Antigen + low adjuvans group	50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a	The antigen group + low adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (100 nmol KLK + 4 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 the first vaccination until 8 months after the first vaccination

Secondary Outcome Measures

Name	Time	Method
Detection by ELISPOT of IFN gamma spot-forming cells in PBMC. Detection by ELISA of IFN gamma production in supernatants of PBMC. Detection of humoral response (IgG) by ELISA.	From first vaccination until 36 months after first vaccination

Trial Locations

Locations (1)

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