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CompletedNCT02679105Updated Sep 4, 2019

Intralymphatic Immunotherapy in Increasing Doses, After Subcutaneous Immunotherapy

A Phase 2/3 interventional study of ALK Alutard birch or 5-grasses and ALK diluent in Rhinitis, Allergic, sponsored by Karolinska Institutet. Completed at 3 sites in Sweden. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-09-04.

Sponsored by Karolinska Institutet · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.

Read the detailed description

38 patients with seasonal allergic rhinitis that have recently (within 20 months) ended a full subcutaneous immunotherapy protocol with birch or grass allergen with improvement but not full symptom relief are recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch.

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Conditions studied

  • Rhinitis, Allergic
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 38 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18-55
  • Accepted and signed informed consent.
  • Recently (within 20 months) ended a full 3 year program with subcutaneous immunotherapy (SCIT) with amelioration of symptoms but not full symptom relief.

Exclusion criteria

Exclusion Criteria:

  • Previously subcutaneous immunotherapy (SCIT) with total symptom relief.
  • Previously SCIT but no symptom improvement at all.
  • Sensitizations to house dust mite or furry animals, with symptoms.
  • Severe atopic dermatitis.
  • Patients with significant diseases other than allergic rhinitis. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
  • Patients with a respiratory tract infection in the past 4 weeks prior to Visit 2.
  • Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants).
  • Known autoimmune or collagen disease
  • Cardiovascular disease
  • Perennial pulmonary disease including asthma
  • Hepatic disease
  • Known renal insufficiency
  • Cancer
  • Hematologic disease
  • Chronic infectious disease
  • Any medication with a possible side-effect of interfering with the immune response
  • Previous immuno- or chemotherapy, apart from SCIT
  • Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)
  • Major metabolic disease
  • Known or suspected allergy to the study product
  • Obesity with BMI > 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection.
  • Patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to Visit 1.
  • Patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to Visit 1.
  • Mental incapability of coping with the study
  • Withdrawal of informed consent
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Placebo comparator
    ALK diluent

    Human albumin

    Drug: ALK diluent

  • Active comparator
    ALK Alutard birch or 5-grasses

    Grass pollen suspension or birch pollen suspension

    Drug: ALK Alutard birch or 5-grasses

Interventions

  • DrugALK Alutard birch or 5-grasses

    3 injections with 4-5 weeks interval.

    Also known as: ALK Alutard birch pollen or ALK Alutard grass pollen, ATC-code V01AA, V04CL and V07AB

  • DrugALK diluent

    0,3% human albumin

    Also known as: Human albumin

06

What researchers measure

Primary outcomes

  1. Total daily symptoms and medications score

    Difference between active and placebo group in total daily symptoms and medications score during the pollen season.

    Time frame: 5-7 months after treatment

Secondary outcomes

  1. Improvement on Visual Analogue Scale (VAS)

    Difference in improvement on VAS between active and placebo group.

    Time frame: During pollen season and recalled after pollen season, approximately 1 year after the start of treatment.

  2. Change in skin prick test reactivity

    Tested with ALK Soluprick. Measured as the wheal area in millimeter for birch- or grass pollen.

    Time frame: 4-8 weeks after treatment, 9-12 months after treatment

  3. Change in symptoms score after nasal allergen challenge

    0,1 ml of ALK Aquagen Birch or Timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded.

    Time frame: 4-8 weeks after treatment, 9-12 months after treatment

  4. Difference between active and placebo group in Quality of Life measured with Juniper Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

    At peak pollen season after treatment.

    Time frame: Up to 7 months after treatment.

  5. Difference between active and placebo group in Quality of Life measured with Sino Nasal Outcome Test -22 (SNOT-22)

    At peak pollen season after treatment.

    Time frame: Up to 7 months after treatment.

  6. Change in allergen specific S- antibody levels.

    IgE, IgG, IgG4

    Time frame: 4-8 weeks after treatment, 9-12 months after treatment

  7. Incidence of adverse events graded as mild-moderate-severe

    Time frame: From first injection to 30 days after last injection.

07

Study locations

3 sites
  • Allergy Unit, Södra Älvsborgs Hospital
    Borås, 501 82, Sweden
  • ENT department, Skånes University Hospital Malmö and Lund
    Malmö, 205 02, Sweden
  • ENT department, Karolinska University Hospital
    Stockholm, 141 86, Sweden
08

References and documents

Publications

  • Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10. PubMed 19001265 ↗
  • Hylander T, Latif L, Petersson-Westin U, Cardell LO. Intralymphatic allergen-specific immunotherapy: an effective and safe alternative treatment route for pollen-induced allergic rhinitis. J Allergy Clin Immunol. 2013 Feb;131(2):412-20. doi: 10.1016/j.jaci.2012.10.056. PubMed 23374268 ↗
  • Witten M, Malling HJ, Blom L, Poulsen BC, Poulsen LK. Is intralymphatic immunotherapy ready for clinical use in patients with grass pollen allergy? J Allergy Clin Immunol. 2013 Nov;132(5):1248-1252.e5. doi: 10.1016/j.jaci.2013.07.033. Epub 2013 Sep 13. No abstract available. PubMed 24035151 ↗
  • Hellkvist L, Hjalmarsson E, Weinfeld D, Dahl A, Karlsson A, Westman M, Lundkvist K, Winqvist O, Georen SK, Westin U, Cardell LO. High-dose pollen intralymphatic immunotherapy: Two RDBPC trials question the benefit of dose increase. Allergy. 2022 Mar;77(3):883-896. doi: 10.1111/all.15042. Epub 2021 Aug 29. PubMed 34379802 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02679105
Lead sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital, Skane University Hospital, Sodra Alvsborgs Hospital
Responsible party
Lars Olaf Cardell (Professor, Head of Division, MD, Karolinska Institutet) — Principal investigator
First posted
Feb 10, 2016
Start date
May 2015
Primary completion
Oct 2016
Completion
Mar 2019
Last update
Sep 4, 2019

Study contacts

Lars Olaf Cardell, Professor
principal investigator · Karolinska University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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