A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) (THYB-03)

April 16, 2015 updated by: Statens Serum Institut

A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered in Different Antigen/Adjuvant Formulations in TST Negative and TST Positive Volunteers at 0 and 2 Months

The study has the following objectives:

Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective To determine the immunogenicity profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Number of trial subjects=48 Investigational product=Ag85B - ESAT-6 + IC31 Dosage Group 1: TST negative, 50 µg antigen Group 2: TST negative, 50 µg antigen + fixed adjuvant Group 3: BCG vaccinated, 50 µg antigen + fixed adjuvant Group 4 : Latent TB, 50 µg antigen + fixed adjuvant Dosage volume 0.5 ml Administration Intramuscularly into deltoid muscle, alternate arms at day 0 (right) and day 56 (left).

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male between 18 and 40 years old
  • TST negative groups: TST- and negative QuantiFERON-TB Gold In tube test
  • BCG group: known to be BCG-vaccinated > 2 years before(scar, vaccination card), TST+ (> 6 or any documented value > 6 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: latent TB, TST+ ( = or > 10 mm or documented = or > 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:

  • Confirmed active TB based on clinical evaluation(history, physical findings and investigations)
  • Vaccinated with any vaccine 3 months before first vaccination
  • Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins)
  • 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 considered clinically relevant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 12 TST negative volunteers antigen only
Biological: Antigen (Ag85B-ESAT-6)
Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Experimental: 12 TST negative volunteers
Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Experimental: 12 BCG vaccinated volunteers
Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
Experimental: 12 with Latent TB infection >= 2 years ago
Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety on Physical examination , and Laboratory safety tests of hematology clinical chemistry
Time Frame: 12 visits in a total of 224 days duratiion from the day of first vaccinantion
12 visits in a total of 224 days duratiion from the day of first vaccinantion

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity assessment by: A.Detection of IFN gama production after stimulation with Ag85B, ESAT-6 and H1. B.Detection of IgG antibodies to recombinant proteins Ag85B, ESAT-6 and H1 in serum/plasma.
Time Frame: 12 visits in a total of 224 days duratiion from the day of first vaccinantion
12 visits in a total of 224 days duratiion from the day of first vaccinantion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Statens Serum Institut

Investigators

  • Principal Investigator: Jemal Hussein, MD, Armauer Hansen Research Institue/AHRI/,Ethiopia
  • Study Director: Peter Bang, Msc, Statens serum Institute/SSI/,Denamrk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Estimate)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THYB-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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