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Effect of Intralymphatic Immunotherapy

NCT02255604 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-05-24

Study results available
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Summary

The investigators want to investigate whether specific immunotherapy can be delivered directly into a lymph node. The investigators think that a direct introduction of allergen to the antigen presenting cells in the lymph node a give a strong immune response and that this can change the number of injections needed in allergen immunotherapy. The investigators do measurements of clinical effect and a variety of paraclinical test to see if the investigators can find af biomarker of successful specific immune therapy of grass allergy.

Conditions

  • Allergy
  • Immune Tolerance
  • Injection Site Discomfort

Interventions

DRUG

Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.

4

DRUG

alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.

3 injection into a lymphnode

DRUG

0.1 ml Isoton saline

4 injection into a lymphnode

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Søren Helbo SH Skaarup, MD · Lungemedicinsk forskningsafdeling. Aarhus University Hospital.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-09-30
Completion
2017-02-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02255604 on ClinicalTrials.gov