NCT00929396

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2009

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

1.8 years

First QC Date

June 26, 2009

Last Update Submit

January 18, 2013

Conditions

Tuberculosis

Keywords

TuberculosisVaccineAg85BESAT-6IC31

Outcome Measures

Primary Outcomes (1)

  • Physical examination. Local adverse events.Systemic adverse events. Laboratory safety tests including urine safety tests.

    From first vaccination until 8 months after the first vaccination

Secondary Outcomes (1)

  • Detection by ELISPOT of IFNgamma spot-forming cells in PBMCs. Detection by ELISA of IFNgamma production in supernatants of PBMC. Detection by ELISA of IgG antibodies in serum/plasma. Detection by Elisa of TNFalfa and IFNgamma in serum

    From first vaccination until 8 months after first vaccination

Study Arms (2)

Latent TB infection group

EXPERIMENTAL

The latent TB group will receive two injections of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart.

Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)

BCG vaccinated group

EXPERIMENTAL

The BCG vaccinated group will receive two vaccinations of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart

Biological: 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)

Interventions

50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)BIOLOGICAL

o,5 mL suspension for injection x 2 with 2 months interval

Also known as: Antigen H1 + adjuvant IC31
BCG vaccinated group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female between 18 and 55 years old
  • BCG group: Known to be BCG-vaccinated over 2 years before, PPD positive (range 6-15 mm or any documented value between 6-15 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: Known to be treated for latent TB, PPDpositive (equal or over 10 mm or documented equal or over 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:

  • Granulomatous disease (by chest X-ray)
  • 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
  • Participation in other clinical trials
  • Known hypersensitivity to any of the vaccine components
  • Laboratory parameters outside of normal range judged by PI to be clinically relevant
  • Pregnant women/planned pregnancy and/or breastfeeding within the trial period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Centre

Leiden, RC Leiden, 2300, Netherlands

Location

Related Publications (1)

  • van Dissel JT, Soonawala D, Joosten SA, Prins C, Arend SM, Bang P, Tingskov PN, Lingnau K, Nouta J, Hoff ST, Rosenkrands I, Kromann I, Ottenhoff TH, Doherty TM, Andersen P. Ag85B-ESAT-6 adjuvanted with IC31(R) promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in volunteers with previous BCG vaccination or tuberculosis infection. Vaccine. 2011 Mar 3;29(11):2100-9. doi: 10.1016/j.vaccine.2010.12.135. Epub 2011 Jan 20.

    PMID: 21256189DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Adjuvants, PharmaceuticIC31 adjuvant

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Jaap van Dissel, MD, Prof.

    Leiden University Medical Centre

    PRINCIPAL INVESTIGATOR

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

June 26, 2009

First Posted

June 29, 2009

Study Start

September 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

NL(1)