Study to Asses Efficacy of Intralymphatic Immunotherapy

Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01166269

Acronym

ILIT

Enrollment

Registered

2010-07-21

Start date

2010-07-31

Completion date

2012-11-30

Last updated

2012-11-08

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

Conditions

Allergy

Keywords

grass-pollen allergy

Brief summary

The purpose of the study is to try a new route for specific immunotherapy (SIT). The current treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50 injections subcutaneously in the upper arm. The investigators believe that there is additional effect if the allergen is injected directly into the lymph node, since it is here, the allergen presentation is happening. The trial has been performed in Switzerland with significant effect of only three injections of grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457). The investigators would like to see what happens if the the dose is doubled, so the patients will receive 6 injections all in all, with the same amount of allergen as the earlier study (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note their symptoms in a diary. The patients will be divided into three groups using allocation: 1 group with 6 injections of allergen 1 group with 3 injections of allergen and 3 injections of placebo 1 group with 6 injections of placebo. The trial will be double blinded.

Interventions

BIOLOGICALphleum pratense (grass-allergen)

6 injections of grass-allergen. Every dose will be 1000 SQ-U.

BIOLOGICALphleum pratense (grass allergen)

3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline)

OTHERphysiological saline

6 injections of placebo (physiological saline)in a lymph node.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* grass pollen allergy through at least 2 seasons * positive skin prick test * positive Specific IgE of at least 2. (CAP) * Signed informed consent * for females a negative pregnancy test.

Exclusion criteria

* out of age limits * rhinoconjunctivitis all year round. * uncontrolled seasonal asthma * patients treated with steroids continuously or beta-blockers. * pregnancy and breastfeeding * HIV, Hepatitis B+c, and other immunological diseases. * psychiatric disease * treatment with SCIT or SLIT within the last 5 years * participation in other clinical trials within the last 3 months.

Design outcomes

Primary

Measure	Time frame	Description
symptom improvement	2 seasons. (2 years)	The patients will fill out a diary during the grasspollen-season before and after treatment. Also they will fill out a form for the general status of the season passed.

Secondary

Measure	Time frame
Improvement of reactivity of skin prick test and Specific IgE	2 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026