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A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers (THYB-02)

Primary Purpose

Tuberculosis

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
50 microg. antigen + adjuvant (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)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Leiden University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Latent TB infection group

BCG vaccinated group

Arm Description

The latent TB group will receive two injections of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart.

The BCG vaccinated group will receive two vaccinations of 50 microgram antigen + adjuvant (500 nmol KLK + 20 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 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

Full Information

First Posted
June 26, 2009
Last Updated
January 18, 2013
Sponsor
Statens Serum Institut
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1. Study Identification

Unique Protocol Identification Number
NCT00929396
Brief Title
A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (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.

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
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Latent TB infection group
Arm Type
Experimental
Arm Description
The latent TB group will receive two injections of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart.
Arm Title
BCG vaccinated group
Arm Type
Experimental
Arm Description
The BCG vaccinated group will receive two vaccinations of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart
Intervention Type
Biological
Intervention Name(s)
50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
Other Intervention Name(s)
Antigen H1 + adjuvant IC31
Intervention Description
o,5 mL suspension for injection x 2 with 2 months interval
Intervention Type
Biological
Intervention Name(s)
50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
Other Intervention Name(s)
Antigen H1 + adjuvant IC31
Intervention Description
o,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 first vaccination until 8 months after the first vaccination
Secondary Outcome Measure Information:
Title
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
Time Frame
From first vaccination until 8 months after first vaccination

10. Eligibility

Sex
All
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 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
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
21256189
Citation
van Dissel JT, Soonawala D, Joosten SA, Prins C, Arend SM, Bang P, Tingskov PN, Lingnau K, Nouta J, Hoff ST, Rosenkrands I, Kromann I, Ottenhoff TH, Doherty TM, Andersen P. Ag85B-ESAT-6 adjuvanted with IC31(R) promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in volunteers with previous BCG vaccination or tuberculosis infection. Vaccine. 2011 Mar 3;29(11):2100-9. doi: 10.1016/j.vaccine.2010.12.135. Epub 2011 Jan 20.
Results Reference
derived

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

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