Clinical trial NCT01003093: A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine
Official title: A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered at 0 and 2 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tuberculosis
Keywords: Tuberculosis
Vaccine
Ag85B
ESAT-6
IC31
Lead sponsor: Statens Serum Institut
Sponsor class: OTHER
First posted: 2009-10-28
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests.
timeFrame: From the first vaccination until 8 months after the first vaccination
Secondary outcomes:
measure: 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.
timeFrame: From first vaccination until 36 months after first vaccination
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
state: RC Leiden
Study officials:
affiliation: Leiden University Medical Centre
name: Jaap van Dissel, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: van 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.