Intralymphatic immunotherapy with Vitamin D for grass pollen allergies
Official title: Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
Run by Karolinska Institutet · NCT06061848 · Data updated 2026-11-12
This study is testing if a new treatment using Vitamin D with intralymphatic immunotherapy can help people with grass pollen allergies feel better during allergy season.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 360 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 3 sites (Lund and 2 other locations) |
| Status | Recruiting |
| Started | February 1, 2023 |
| Main results expected | December 28, 2030 |
| Study ends | December 28, 2031 |
| Registry record updated | October 21, 2024 |
| Trial ID | NCT06061848 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with moderate to severe allergic rhinitis due to grass pollen and a Rhinitis Total Symptom Score of 8 or higher.
✕Probably not a fit
Patients with chronic rhinosinusitis, significant comorbidities, or those who have previously undergone immunotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of intralymphatic immunotherapy (ILIT) enhanced by Vitamin D in treating patients with allergic rhinitis caused by grass pollen. A total of 360 participants will be randomly assigned to receive either sublingual immunotherapy (SLIT) or ILIT, with a subset receiving Vitamin D or a placebo before treatment. The primary outcome will be assessed through daily symptom and medication scores during the grass pollen season, aiming to determine the best approach to alleviate allergy symptoms.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from grass pollen allergies.
How similar studies have gone: Previous studies on immunotherapy approaches have shown promise, but this specific combination of ILIT and Vitamin D is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score \>/= 8. * informed consent Exclusion Criteria: * chronic rhinosinusitis with or without nose polyps * Previous immunotherapy (SLIT or SCIT) * BMI \> 35 * house dust mite allergy with symptoms * allergy towards furry animals if exposition cannot be avoided * 25(OH)Vitamin D levels \< 25 or \> 75 nmol/L * use of Vitamin D supplementation or excessive use of sun tanning booths * mental incapacity to follow study protocol * other significant disease * allergy towards study medication * uncontrolled asthma * severe atopic dermatitis * pregnancy or nursing * autoimmune disease * hyper IgE-syndrome * cardiovascular disease * lung disease * liver or kidney disease * hematologic disorder * metabolic disease * chronic infectious disese * medications interacting with the immune system * cancer * previous cytostatic therapy * medication with beta-blockers or ACE-inhibiters, if medication cannot be paused at the day for treatment * drug or alcohol abuse * intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1 * withdrawn consent Exclusion Criteria only for ILIT group (due to vitamin D treatment) * medication witch can interacts with vitD: (ACE-inhibitors, antiepileptic drugs, glycosides, orlistat, statines, thiazide diuretics) * tendency for formation of kidney stones * hyperparathyroidism or other disease conferring risk of hypercalcemia * hereditary pseudohypoparathyroidism with decreased phosphorous secretion * malabsorption or bowel disease with diarrhea * Mb Paget, osteoporosis or sarcoidosis * skin disease at the groin (where the treatment will be injected)
Where it's running
-
Karolinska University Hospital, ENT-department
Stockholm, Sweden Recruiting -
Skåne University Hospital, ENT department
Lund, Sweden Not yet recruiting -
Örebro University Hospital
Örebro, Sweden Not yet recruiting
Study contacts
- Principal investigator: Lars O Cardell, Professor — Karolinska Institutet
- Study coordinator: Agneta Karlsson, Study nurse
- Email: agneta.j.karlsson@regionstockholm.se
- Phone: +46 72 580 29 63
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.