Intralymphatic immunotherapy with Vitamin D for grass pollen allergies
Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
PHASE2; PHASE3 · Karolinska Institutet · NCT06061848
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 |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Drugs / interventions | immunotherapy |
| Locations | 3 sites (Lund and 2 other locations) |
| Trial ID | NCT06061848 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with chronic rhinosinusitis, significant comorbidities, or those who have previously undergone immunotherapy may not benefit from this study.
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 performed: Previous studies on immunotherapy approaches have shown promise, but this specific combination of ILIT and Vitamin D is relatively novel.
Eligibility criteria
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 this trial is running
Lund and 2 other locations
- Skåne University Hospital, ENT department — Lund, Sweden (NOT_YET_RECRUITING)
- Örebro University Hospital — Örebro, Sweden (NOT_YET_RECRUITING)
- Karolinska University Hospital, ENT-department — Stockholm, Sweden (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Allergic Rhinitis Due to Grass Pollen