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

Tuberculosis Clinical Trial

— THYB-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003093
• Other study ID #: THYB-01
• Secondary ID: Eudract number:
• Status: Completed
• Phase: Phase 1
• First received: October 27, 2009
• Last updated: January 18, 2013
• Start date: November 2005
• Est. completion date: June 2008

Study information

• Verified date: January 2013
• Source: Statens Serum Institut
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Nederlands: National Institute for Public Health and the Environment (RIVM)The Netherlands: Comissie Medische Ethiek, Leiden University Medical Centre
• 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 in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

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 microgram antigen (Ag85B + ESAT-6)
0.5 mL suspension for injection x 2 with 2 months interval
• 50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a
0.5 mL suspension for injection x 2 with 2 months interval
• 50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a
0.5 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 the first vaccination until 8 months after the first vaccination	Yes
Secondary	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	No