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A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine (THYB-01)

Primary Purpose

Tuberculosis

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
50 microgram antigen (Ag85B + ESAT-6)
50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a
50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a
Sponsored by
Statens Serum Institut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tuberculosis focused on measuring Tuberculosis, Vaccine, Ag85B, ESAT-6, IC31

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Leiden University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Antigen group + high adjuvans

Antigen group

Antigen + low adjuvans group

Arm Description

The antigen group + high adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (500 nmol KLK + 20 nmol ODN1a) two months apart.

The antigen group received two injections of antigen (Ag85B + ESAT-6) two months apart.

The antigen group + low adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (100 nmol KLK + 4 nmol ODN1a) two months apart.

Outcomes

Primary Outcome Measures

Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests.

Secondary Outcome Measures

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.

Full Information

First Posted
October 27, 2009
Last Updated
January 18, 2013
Sponsor
Statens Serum Institut
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1. Study Identification

Unique Protocol Identification Number
NCT01003093
Brief Title
A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Statens Serum Institut

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
Tuberculosis, Vaccine, Ag85B, ESAT-6, IC31

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antigen group + high adjuvans
Arm Type
Experimental
Arm Description
The antigen group + high adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (500 nmol KLK + 20 nmol ODN1a) two months apart.
Arm Title
Antigen group
Arm Type
Experimental
Arm Description
The antigen group received two injections of antigen (Ag85B + ESAT-6) two months apart.
Arm Title
Antigen + low adjuvans group
Arm Type
Experimental
Arm Description
The antigen group + low adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (100 nmol KLK + 4 nmol ODN1a) two months apart.
Intervention Type
Biological
Intervention Name(s)
50 microgram antigen (Ag85B + ESAT-6)
Other Intervention Name(s)
Antigen H1
Intervention Description
0.5 mL suspension for injection x 2 with 2 months interval
Intervention Type
Biological
Intervention Name(s)
50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a
Other Intervention Name(s)
Antigen H1 + IC31
Intervention Description
0.5 mL suspension for injection x 2 with 2 months interval
Intervention Type
Biological
Intervention Name(s)
50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a
Other Intervention Name(s)
Antigen H1 + IC31
Intervention Description
0.5 mL suspension for injection x 2 with 2 months interval
Primary Outcome Measure Information:
Title
Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests.
Time Frame
From the first vaccination until 8 months after the first vaccination
Secondary Outcome Measure Information:
Title
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.
Time Frame
From first vaccination until 36 months after first vaccination

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaap van Dissel, MD, Prof.
Organizational Affiliation
Leiden University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Centre
City
Leiden
State/Province
RC Leiden
ZIP/Postal Code
2300
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21178394
Citation
Ottenhoff TH, Doherty TM, van Dissel JT, Bang P, Lingnau K, Kromann I, Andersen P. First in humans: a new molecularly defined vaccine shows excellent safety and strong induction of long-lived Mycobacterium tuberculosis-specific Th1-cell like responses. Hum Vaccin. 2010 Dec;6(12):1007-15. doi: 10.4161/hv.6.12.13143. Epub 2010 Dec 1.
Results Reference
derived
PubMed Identifier
20226890
Citation
van Dissel JT, Arend SM, Prins C, Bang P, Tingskov PN, Lingnau K, Nouta J, Klein MR, Rosenkrands I, Ottenhoff TH, Kromann I, Doherty TM, Andersen P. Ag85B-ESAT-6 adjuvanted with IC31 promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in naive human volunteers. Vaccine. 2010 Apr 30;28(20):3571-81. doi: 10.1016/j.vaccine.2010.02.094. Epub 2010 Mar 11.
Results Reference
derived

Learn more about this trial

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

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