Phase 2
N=36
Effect of Intralymphatic Immunotherapy
Allergy · Immune Tolerance · Injection Site Discomfort
Bottom Line
View on ClinicalTrials.gov: NCT02255604 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Change in cSMS (Combined Symptom and Medication Score) — 2.6; 2.3; 4.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml. (Drug); 0.1 ml Isoton saline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Aarhus
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in cSMS (Combined Symptom and Medication Score) |
2.6; 2.3; 4.5 | — |
| SECONDARY Change in Circulating Grass Specific Immunoglobulin E Producing Plasmacells |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Allergic rhinitis to grass pollen, more than 3 mm reaction at skin prick test for grass, age between 18 and 40 years.
Exclusion Criteria
- Uncontrolled asthma.
- Severe asthma with post bronchodilator test forced expiratory volume at 1 second less than 70% of expected.
- Severe co morbidity. Allergy to Fenol or Aluminium hydroxid.
- Any autoimmune diseases. Treatment with beta blocking medicine.
- Any heart diseases.
- Severe arterial hypertension. Kidney failure.
- Known malignancy. Known pregnancy.
Data sourced from ClinicalTrials.gov (NCT02255604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.