NCT01049282

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

January 13, 2010

Last Update Submit

April 16, 2015

Conditions

Tuberculosis

Keywords

safetyimmunogenicityadjuvanted TB subunit vaccine

Outcome Measures

Primary Outcomes (1)

  • Safety on Physical examination , and Laboratory safety tests of hematology clinical chemistry

    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.

    12 visits in a total of 224 days duratiion from the day of first vaccinantion

Study Arms (4)

12 TST negative volunteers antigen only

EXPERIMENTAL
Biological: Antigen (Ag85B-ESAT-6)

12 TST negative volunteers

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

12 BCG vaccinated volunteers

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

12 with Latent TB infection >= 2 years ago

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

Interventions

Antigen (Ag85B-ESAT-6)BIOLOGICAL

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

12 TST negative volunteers antigen only
Antigen (Ag85B-ESAT-6) with adjuvant (IC31)BIOLOGICAL

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

12 BCG vaccinated volunteers12 TST negative volunteers12 with Latent TB infection >= 2 years ago

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • Signed informed consent
  • Prepared to grant authorized persons access to the medical records
  • The volunteer is likely to comply with instructions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29321075DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Antigens

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

  • Jemal Hussein, MD

    Armauer Hansen Research Institue/AHRI/,Ethiopia

    PRINCIPAL INVESTIGATOR

  • Peter Bang, Msc

    Statens serum Institute/SSI/,Denamrk

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

December 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 17, 2015

Record last verified: 2015-04