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

Tuberculosis Clinical Trial

— THYB-03  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049282
• Other study ID #: THYB-03
• Status: Completed
• Phase: Phase 1
• First received: January 13, 2010
• Last updated: April 16, 2015
• Start date: December 2008
• Est. completion date: April 2010

Study information

• Verified date: April 2015
• Source: Statens Serum Institut
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethiopia: Ethical Review CommitteeEthiopia: Drug Administration and Control Authority
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Biological:
• Antigen (Ag85B-ESAT-6)
Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval
• Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Statens Serum Institut

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No