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CompletedNCT01049282THYB-03Updated Apr 17, 2015

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

A Phase 1 interventional study of Antigen (Ag85B-ESAT-6) and Antigen (Ag85B-ESAT-6) with adjuvant (IC31) in Tuberculosis, sponsored by Statens Serum Institut. Completed. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-17.

Sponsored by Statens Serum Institut · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
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Study summary

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.

Read the 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).

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Conditions studied

  • Tuberculosis

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Keywords

  • safety
  • immunogenicity
  • adjuvanted TB subunit vaccine
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In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 39 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Statens Serum Institut is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    12 TST negative volunteers antigen only

    Biological: Antigen (Ag85B-ESAT-6)

  • Experimental
    12 TST negative volunteers

    Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)

  • Experimental
    12 BCG vaccinated volunteers

    Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)

  • Experimental
    12 with Latent TB infection >= 2 years ago

    Biological: Antigen (Ag85B-ESAT-6) with adjuvant (IC31)

Interventions

  • BiologicalAntigen (Ag85B-ESAT-6)

    Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval

  • BiologicalAntigen (Ag85B-ESAT-6) with adjuvant (IC31)

    Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Hussein J, Zewdie M, Yamuah L, Bedru A, Abebe M, Dagnew AF, Chanyalew M, Yohannes AG, Ahmed J, Engers H, Doherty TM, Bang P, Kromann I, Hoff ST, Aseffa A. A phase I, open-label trial on the safety and immunogenicity of the adjuvanted tuberculosis subunit vaccine H1/IC31(R) in people living in a TB-endemic area. Trials. 2018 Jan 10;19(1):24. doi: 10.1186/s13063-017-2354-0. PubMed 29321075 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01049282
Lead sponsor
Statens Serum Institut
Responsible party
Sponsor
First posted
Jan 14, 2010
Start date
Dec 2008
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Apr 17, 2015

Study contacts

Jemal Hussein, MD
principal investigator · Armauer Hansen Research Institue/AHRI/,Ethiopia
Peter Bang, Msc
study director · Statens serum Institute/SSI/,Denamrk

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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