The effect of allergy vaccination given as injections into lymph nodes on the immune system of allergic patients

Effect of Intralymphatic Immunotherapy on Basophil Response and Plasma Cell Kinetics in Allergic Patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005227-33-DK

Enrollment

Registered

2013-03-08

Start date

2013-03-22

Completion date

Unknown

Last updated

2017-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic rhino-conjunctivitis MedDRA version: 14.1 Level: PT Classification code 10039085 Term: Rhinitis allergic System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: PT Classification code 10010744 Term: Conjunctivitis allergic System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: Alutard SQ phleum pratense (ALK 225) Product Name: ALK 225, Alutard SQ phleum pratense Pharmaceutical Form: Solution for injection INN or Proposed INN: grass pollen extract Other descripti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: history of seasonal rhino-conjunctivitis during the grass pollen season positive skin prick test for grass pollen extract informed consent given Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: severe comorbidity uncontrolled asthma bronchiale pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: We would like to evaluate the effect of Intralymphatic Immunotherpy (ILIT) on patients with rhinoconjunctivitis due to grass pollen allergy. 1. Is the clinical effect comparable to that of Subcutaneous Immunotherapy (SCIT) measured in BasoSCIT (funded by Lundbeck grant R32-A1482) 2. Does a booster injection after one year confer additional symptom relief 3. Can enumerating plasma cells one week after injection monitor ILIT? 4. Is the effect on Basophil activation (BAT EC50) a useful tool to document clinical effect? ;Secondary Objective: Establish a new method of immunotherapy, intralymphatic immunotherapy at the Allergy Center, Dept. of Respiratory Diseases, Aarhus University Hospital;Primary end point(s): - a significant decrease in allergic symptoms during grass pollen season -a decrease in basophil sensitivity measured by basophil activation test (10 fold) -detection of specific plasma cells one week after injections;Timepoint(s) of evaluation of this end point: 1. during the grass pollen seasons in 2014 and 2015 2. 3 weeks after injections 3. 1 week after injections	—

Measure

Time frame

Main Objective: We would like to evaluate the effect of Intralymphatic Immunotherpy (ILIT) on patients with rhinoconjunctivitis due to grass pollen allergy. 1. Is the clinical effect comparable to that of Subcutaneous Immunotherapy (SCIT) measured in BasoSCIT (funded by Lundbeck grant R32-A1482) 2. Does a booster injection after one year confer additional symptom relief 3. Can enumerating plasma cells one week after injection monitor ILIT? 4. Is the effect on Basophil activation (BAT EC50) a useful tool to document clinical effect? ;Secondary Objective: Establish a new method of immunotherapy, intralymphatic immunotherapy at the Allergy Center, Dept. of Respiratory Diseases, Aarhus University Hospital;Primary end point(s): - a significant decrease in allergic symptoms during grass pollen season -a decrease in basophil sensitivity measured by basophil activation test (10 fold) -detection of specific plasma cells one week after injections;Timepoint(s) of evaluation of this end point: 1. during the grass pollen seasons in 2014 and 2015 2. 3 weeks after injections 3. 1 week after injections

—

Secondary

Measure	Time frame
Secondary end point(s): -a possible positive effect of a booster injection after one year -changes in specific immunoglobulins (IgE, IgX);Timepoint(s) of evaluation of this end point: 1. season 2015 2. measurements performed througout the whole study, 2013-2015	—

Countries

Denmark

Contacts

Public ContactPILIT

Department of Respiratory Diseases

hans.jurgen.hoffmann@ki.au.dk004578462106

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026