Trial Outcomes & Findings for Effect of Intralymphatic Immunotherapy (NCT NCT02255604)

Results Overview

cSMS, Combined symptom and medication score, during grass pollen season in three years follow up. Minimal score 0, Maximal score 18. Higher score means worse outcome. Scale: Itchy/red eys: 0-3, Runny eyes: 0-3, Itchy nose: 0-3, Runny nose: 0-3, Block nose: 0-3, Sneezes: 0-3. Topical antihistamine 1.5 points/1 point. Nasal corticosteroid: 1 point/2 points. Oral antihistamine: 6 points/1 point. Oral prednisolon 1.5 point /3 points. Elements are summed to a combined score. Different combination methods exists. EAACI recommends means, i.e. symptoms 0-3 plus medicationscore 0-3. This scoringsystem was applied in the last follow-up year.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

3 years

Results posted on

2021-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Intralymphatic Immune Therapy Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml. Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4	3 Intralymphatic Immune Therapy Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml. Patients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection. alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode	no Intralymphatic Immune Therapy Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline. Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control. 0.1 ml Isoton saline: 4 injection into a lymphnode
Overall Study STARTED	12	12	12
Overall Study COMPLETED	10	11	9
Overall Study NOT COMPLETED	2	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Intralymphatic Immunotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intralymphatic Immune Therapy n=12 Participants Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml. Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4	3 Intralymphatic Immune Therapy n=12 Participants Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml. Patients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection. alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode	no Intralymphatic Immune Therapy n=12 Participants Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline. Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control. 0.1 ml Isoton saline: 4 injection into a lymphnode	Total n=36 Participants Total of all reporting groups
Age, Continuous	31.67 years STANDARD_DEVIATION 5.52 • n=5 Participants	29.92 years STANDARD_DEVIATION 6.80 • n=7 Participants	30.58 years STANDARD_DEVIATION 7.43 • n=5 Participants	30.72 years STANDARD_DEVIATION 6.58 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants

PRIMARY outcome

Timeframe: 3 years

cSMS, Combined symptom and medication score, during grass pollen season in three years follow up. Minimal score 0, Maximal score 18. Higher score means worse outcome. Scale: Itchy/red eys: 0-3, Runny eyes: 0-3, Itchy nose: 0-3, Runny nose: 0-3, Block nose: 0-3, Sneezes: 0-3. Topical antihistamine 1.5 points/1 point. Nasal corticosteroid: 1 point/2 points. Oral antihistamine: 6 points/1 point. Oral prednisolon 1.5 point /3 points. Elements are summed to a combined score. Different combination methods exists. EAACI recommends means, i.e. symptoms 0-3 plus medicationscore 0-3. This scoringsystem was applied in the last follow-up year.

Outcome measures

Outcome measures
Measure	Intralymphatic Immune Therapy n=10 Participants Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml. Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4	3 Intralymphatic Immune Therapy n=11 Participants Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml. Patients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection. alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode	no Intralymphatic Immune Therapy n=9 Participants Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline. Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control. 0.1 ml Isoton saline: 4 injection into a lymphnode
Change in cSMS (Combined Symptom and Medication Score)	2.6 score on a scale Interval 1.8 to 3.4	2.3 score on a scale Interval 1.5 to 3.0	4.5 score on a scale Interval 3.0 to 6.0

SECONDARY outcome

Timeframe: one week from vaccinations

Population: Due to technical flow-cytometry problem could analysis of circulating grass specific immunoglobulin E producing plasma cells not be performed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Due to technical problems data was not recorded at all time points and results are missing.

Flowcytometry based analysis of basophil cells reaction to allergen provocation.

Outcome measures

Outcome data not reported

Adverse Events

Intralymphatic Immune Therapy

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

3 Intralymphatic Immune Therapy

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

no Intralymphatic Immune Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intralymphatic Immune Therapy n=12 participants at risk Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml. Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4	3 Intralymphatic Immune Therapy n=12 participants at risk Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml. Patients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection. alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode	no Intralymphatic Immune Therapy n=12 participants at risk Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline. Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control. 0.1 ml Isoton saline: 4 injection into a lymphnode
Skin and subcutaneous tissue disorders Local reaction	33.3% 4/12 • Number of events 4 • 3 years	33.3% 4/12 • Number of events 4 • 3 years	0.00% 0/12 • 3 years
Immune system disorders Headache	25.0% 3/12 • Number of events 3 • 3 years	0.00% 0/12 • 3 years	8.3% 1/12 • Number of events 1 • 3 years
Immune system disorders anaphylaxis	0.00% 0/12 • 3 years	8.3% 1/12 • Number of events 1 • 3 years	0.00% 0/12 • 3 years

Additional Information

Hans Jürgen Hoffmann

Aarhus Universitets Hospital

Phone: 7845000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place