NCT00470457

Brief Summary

Allergen specific immunotherapy (SIT) is the only causative treatment of IgE-mediated allergies. The disadvantages of SIT, however, are the requirement of numerous allergen administrations over three to five years, and that the treatment itself causes frequent allergic reactions. We aim at enhancing grass pollen SIT in hay fever patients by injecting the allergen directly into subcutaneous lymph nodes. In a monocentric randomized trial safety and efficacy of intralymphatic immunotherapy (ILIT) with 3 low dose grass pollen extract injections over 2 months are compared to subcutaneous immunotherapy (SCIT) using 54 injections over 3 years.

  • Trial with immunodulatory product / biological

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2001

Typical duration for phase_2

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

June 1, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

First QC Date

May 4, 2007

Last Update Submit

December 2, 2015

Conditions

Rhinoconjunctivitis Due to Grass Pollen Allergy

Outcome Measures

Primary Outcomes (1)

  • Safety efficacy and toxicity

    3 years

Interventions

Allergen specific immunotherapyBIOLOGICAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • History of allergic rhino-conjunctivitis in spring and summer
  • Age 18 years to 65 years
  • Positive skin prick test to grass pollen

You may not qualify if:

  • Blood donation within previous 30 days
  • Surgery within the previous 30 days
  • Use of investigational drugs within previous 90 days
  • Pregnancy or nursing
  • Mastocytosis
  • Significant cardiovascular disease
  • Hypertension
  • Active infectious disease
  • Significant hepatic disease
  • Significant renal disease
  • Significant hematological disorder
  • Significant pulmonary disease
  • Moderate or severe asthma
  • Autoimmune disease
  • History of malignancy.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Dermatology University Hospital of Zurich

Zurich, Switzerland

Location

Related Publications (1)

  • Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.

    PMID: 19001265DERIVED

Study Officials

  • Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2007

First Posted

May 7, 2007

Study Start

June 1, 2001

Study Completion

March 1, 2005

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

CH(1)