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Study on the Effectiveness of Intralyphatic Immunotherapy with Vitamin D for Patients with Allergic Rhinitis Using Phleum Pratense and Colecalciferol

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for allergic rhinitis, commonly known as hay fever, which is an allergy to grass pollen. The study will explore the use of a treatment called intralymphatic immunotherapy (ILIT), which involves injecting small amounts of allergens directly into a lymph node to help the body build tolerance. This treatment will be combined with vitamin D to see if it enhances the effectiveness of the therapy. The study will also compare this combination treatment to another method called sublingual immunotherapy (SLIT), where the allergen is placed under the tongue.

Participants in the study will receive either the ILIT treatment with vitamin D, ILIT without vitamin D, or a placebo. The purpose of the study is to determine if the combination of ILIT and vitamin D leads to a significant improvement in symptoms during the grass pollen season compared to ILIT alone. The study will monitor participants over a period of time to assess changes in their symptoms and quality of life related to their allergy.

The study will involve several visits where participants will receive their assigned treatment and undergo assessments to track their progress. These assessments will include questionnaires about their symptoms and quality of life, as well as tests to measure immune responses. The goal is to find out if the combination of ILIT and vitamin D can provide better relief from hay fever symptoms compared to other treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age (18-60 years) and verified grass allergy with moderate to severe symptoms.

    Written consent is required to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline symptoms using the Combined Symptom Medication Score (CSMS) during the pollen season before treatment.

  3. Step 3

    Treatment phase

    The treatment involves intralymphatic immunotherapy (ILIT) combined with vitamin D.

    The ILIT is administered through subcutaneous injection using a product called Alutard SQ Timotej, which is a suspension for injection.

    Vitamin D is administered as colecalciferol, which is given intramuscularly.

    The frequency and duration of administration are determined by the study protocol.

  4. Step 4

    Sublingual treatment

    A sublingual treatment is also part of the study, using a product called Grazax, which is a sublingual lyophilisate.

    This treatment is administered under the tongue.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, symptoms are monitored using the CSMS during the grass pollen season.

    Additional assessments include the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), NTS score, and visual analogue scale (VAS).

    Nasal wash analyses and blood tests are conducted to measure immune cell levels and cytokines before and after treatment.

  6. Step 6

    End of study

    The study is estimated to conclude by December 31, 2029.

    Final assessments compare post-treatment CSMS with baseline and placebo group scores.

Who can join the trial?

3 criteria

  • Age: You must be between 18 and 60 years old at the time of screening.
  • Confirmed grass allergy: You should have moderate to severe symptoms. This is measured by a score called RTSS (Rhinoconjunctivitis Total Symptom Score), which should be greater than 8. This score helps to understand how severe your allergy symptoms are.
  • Written consent: You need to provide written permission to participate in the study. This means you agree to take part after understanding what the study involves.

Who cannot join the trial?

10 criteria

  • Patients who are not between 18 and 65 years old cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible.
  • Patients with other significant health conditions that might interfere with the study cannot join.
  • Patients who have participated in another clinical trial within the last 30 days are excluded.
  • Patients who have a known allergy to the study medication or its ingredients cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
  • Patients with a history of drug or alcohol abuse within the past year are excluded.
  • Patients who have received certain treatments for their allergy in the past 6 months cannot join.
  • Patients with a history of severe allergic reactions, known as **anaphylaxis**, are not eligible.
  • Patients who have a condition that affects their immune system, making it weaker, cannot participate.
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Investigated drugs

  • ILIT (Intralymphatic Immunotherapy)

    is a treatment designed to help people with moderate to severe grass allergy. It involves injecting small amounts of allergens directly into the lymph nodes to help the immune system become less sensitive to the allergens over time. This therapy aims to reduce allergy symptoms during the pollen season.

  • Vitamin D

    is used in combination with ILIT in this study. It is believed that Vitamin D can enhance the effectiveness of the immunotherapy, potentially leading to better control of allergy symptoms. Vitamin D is known for its role in supporting the immune system, and its addition to the treatment may help improve the overall response to the allergens.

What is already known about the treatment

Vitamin D – This medication is administered orally or through injection, depending on the specific treatment protocol. It is currently being studied in combination with intralymphatic immunotherapy (ILIT) for its potential to enhance treatment outcomes in patients with moderate to severe grass pollen allergy, also known as allergic rhinitis. The main therapeutic indication is to improve allergy symptoms during the pollen season. At the molecular level, Vitamin D is believed to modulate the immune system, potentially reducing inflammation and allergic responses. It is classified as a vitamin and is widely recognized for its role in bone health and immune function.

Investigated diseases

Allergic Rhinitis – Allergic rhinitis is a condition where the immune system overreacts to allergens in the air, such as pollen, dust, or pet dander. This reaction causes symptoms like sneezing, itching, nasal congestion, and runny nose. The condition can be seasonal, often referred to as hay fever, or perennial, occurring year-round. Over time, exposure to allergens can lead to persistent symptoms and discomfort. The severity of symptoms can vary, with some individuals experiencing mild irritation and others facing more significant disruptions to daily life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-515271-35-00Estimated enrolment360 patientsSponsorKarolinska Institutet

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