A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine
THYB-01
A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered at 0 and 2 Months
2 other identifiers
interventional
36
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2005
Typical duration for phase_1
1 active site
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
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 27, 2009
CompletedFirst Posted
Study publicly available on registry
October 28, 2009
CompletedJanuary 21, 2013
January 1, 2013
2.3 years
October 27, 2009
January 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (3)
Antigen group + high adjuvans
EXPERIMENTALThe antigen group + high adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (500 nmol KLK + 20 nmol ODN1a) two months apart.
Antigen group
EXPERIMENTALThe antigen group received two injections of antigen (Ag85B + ESAT-6) two months apart.
Antigen + low adjuvans group
EXPERIMENTALThe antigen group + low adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (100 nmol KLK + 4 nmol ODN1a) two months apart.
Interventions
0.5 mL suspension for injection x 2 with 2 months interval
0.5 mL suspension for injection x 2 with 2 months interval
0.5 mL suspension for injection x 2 with 2 months interval
Eligibility Criteria
You may qualify if:
- Male
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leiden University Medical Centre
Leiden, RC Leiden, 2300, Netherlands
Related Publications (2)
Ottenhoff TH, Doherty TM, van Dissel JT, Bang P, Lingnau K, Kromann I, Andersen P. First in humans: a new molecularly defined vaccine shows excellent safety and strong induction of long-lived Mycobacterium tuberculosis-specific Th1-cell like responses. Hum Vaccin. 2010 Dec;6(12):1007-15. doi: 10.4161/hv.6.12.13143. Epub 2010 Dec 1.
PMID: 21178394DERIVEDvan Dissel JT, Arend SM, Prins C, Bang P, Tingskov PN, Lingnau K, Nouta J, Klein MR, Rosenkrands I, Ottenhoff TH, Kromann I, Doherty TM, Andersen P. Ag85B-ESAT-6 adjuvanted with IC31 promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in naive human volunteers. Vaccine. 2010 Apr 30;28(20):3571-81. doi: 10.1016/j.vaccine.2010.02.094. Epub 2010 Mar 11.
PMID: 20226890DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaap van Dissel, MD, Prof.
Leiden University Medical Centre
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2009
First Posted
October 28, 2009
Study Start
November 1, 2005
Primary Completion
March 1, 2008
Study Completion
June 1, 2008
Last Updated
January 21, 2013
Record last verified: 2013-01