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A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine

A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered at 0 and 2 Months

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01003093
Acronym
THYB-01
Enrollment
36
Registered
2009-10-28
Start date
2005-11-30
Completion date
2008-06-30
Last updated
2013-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Keywords

Tuberculosis, Vaccine, Ag85B, ESAT-6, IC31

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 in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB

Interventions

BIOLOGICAL50 microgram antigen (Ag85B + ESAT-6)

0.5 mL suspension for injection x 2 with 2 months interval

BIOLOGICAL50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a

0.5 mL suspension for injection x 2 with 2 months interval

BIOLOGICAL50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a

0.5 mL suspension for injection x 2 with 2 months interval

Sponsors

Statens Serum Institut
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Male * Healthy based on medical examination/history at the inclusion * Age between 18 and 55 years * Signed informed consent * Prepared to grant authorized persons access to the medical records * The volunteer is likely to comply with instructions

Exclusion criteria

* Known exposure to TB before (or expected during) the trial * Prior BCG vaccination * Granulomatous disease (by chest X-ray, autoimmune screen) * 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 (HBsAg, HBsAb, HBc total and IgM ab and HCV, HIV-1 and HIV2 ab) * Participation in other clinical trials * Positive Mantoux or QuantiFERON-TB Gold * Known hypersensitivity to any of the vaccine components * Laboratory parameters outside of normal ranges considered clinically relevant

Design outcomes

Primary

MeasureTime frame
Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests.From the first vaccination until 8 months after the first vaccination

Secondary

MeasureTime frame
Detection by ELISPOT of IFN gamma spot-forming cells in PBMC. Detection by ELISA of IFN gamma production in supernatants of PBMC. Detection of humoral response (IgG) by ELISA.From first vaccination until 36 months after first vaccination

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026