Study to Asses Efficacy of Intralymphatic Immunotherapy (ILIT)

Rigshospitalet

Status and phase: Completed; Phase 3; Phase 2

Conditions: Allergy

Treatments: Biological: phleum pratense (grass-allergen); Other: physiological saline; Biological: phleum pratense (grass allergen)

Study type: Interventional

Funder types: Other

Identifiers

NCT01166269

ILIT

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 3 patient groups, including a placebo group

Grass-Allergen x 6

Experimental group

Description:

This arm will receive 6 injections of allergen.

Treatment:

Biological: phleum pratense (grass-allergen)

grass-allergen x 3 and placebo x 3

Active Comparator group

Description:

this arm will receive 3 injections of allergen, and 3 injections of placebo.

Treatment:

Biological: phleum pratense (grass allergen)

placebo x 6

Placebo Comparator group

Description:

this arm will receive 6 injections of placebo.

Treatment:

Other: physiological saline