Is Intralymphatic Allergen Immunotherapy Effective and Safe?

Allergic Rhinitis Due to Grass Pollen Clinical Trial

Official title:

Is Intralymphatic Allergen Immunotherapy Effective and Safe: a Human Randomized Clinical Trial- Substudy Borås With a Randomized Preseasonal Booster

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210193
• Other study ID #: ILIT Borås EPN 2014/251
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 25, 2014
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. The next year the patients were randomized double blind to an active or placebo booster injection of 1000 SQ-U before the pollen season. Grass specific IgG4 levels were measured before and at various time ponts after treatment.

Description:

The purpose of the study is to evaluate whether intralymphatic administration of AIT is a safe and effective treatment for patients with pollen-induced allergic rhinitis. The long term goal is to provide a base for a more efficient administration of ASIT, which will reduce both the dose necessary and the number of clinic visits associated with the conventional subcutaneous ASIT.

The aim of the present substudy is to evaluate if a randomized preseasonal ILIT booster, after three open label ILIT injections, can increase the allergen specific IgG4 antibodies, and if the IgG4 increase can be correlated to clinical effect characterized with seasonal questionnaires.

The first part of the study is completed and published (PMID: 23374268)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Age 18-50,

• Seasonal allergic symptoms for birch and/or grass verified by skin prick test,

• Accepted informed consent

Exclusion Criteria:

• Pregnancy or nursing

• Autoimmune or collagen disease (known)

• Cardiovascular disease

• Perennial pulmonary disease

• Hepatic disease

• Renal disease

• Cancer

• Any medication with a possible side-effect of interfering with the immune response

• Previous immuno- or chemotherapy

• Chronic diseases

• Other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease)

• Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with ß-blockers)

• Major metabolic disease

• Known or suspected allergy to the study product

• Alcohol or drug abuse

• Mental incapability of coping with the study

• Withdrawal of informed consent

Related Conditions & MeSH terms

• Allergic Rhinitis Due to Grass Pollen
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• ALK Alutard 5-grasses
0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection
• ALK Diluent
0.1 mL of ALK Diluent as an intralymphatic injection

Locations

Country	Name	City	State
Sweden	Allergy Unit, Södra Älvsborgs Hospital	Borås

Sponsors (1)

Lead Sponsor	Collaborator
Lars Olaf Cardell

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Hylander T, Larsson O, Petersson-Westin U, Eriksson M, Kumlien Georén S, Winqvist O, Cardell LO. Intralymphatic immunotherapy of pollen-induced rhinoconjunctivitis: a double-blind placebo-controlled trial. Respir Res. 2016 Jan 27;17:10. doi: 10.1186/s12931-016-0324-9. — View Citation

Konradsen JR, Grundström J, Hellkvist L, Thu Tran TA, Andersson N, Gafvelin G, Kiewiet MBG, Hamsten C, Tang J, Parkin RV, Shamji MH, Hedlin G, Cardell LO, van Hage M. Intralymphatic immunotherapy in pollen allergic young adults with rhinoconjunctivitis and mild asthma: a randomized trial. J Allergy Clin Immunol. 2019 Nov 24. pii: S0091-6749(19)31599-4. doi: 10.1016/j.jaci.2019.11.017. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the serum-level of timothy specific IgG4 after 1 month	Blood samples with measurement of allergen specific blocking IgG4 antibodies	Change between baseline and 1 month after treatment.
Primary	Change in the serum-level of timothy specific IgG4 after 9 months	Blood samples with measurement of allergen specific blocking IgG4 antibodies	Change between baseline and 9 months after treatment.
Primary	Change in the serum-level of timothy specific IgG4 2 months after booster	Blood samples with measurement of allergen specific blocking IgG4 antibodies	Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).
Primary	Change in the serum-level of timothy specific IgG4 10 months after booster	Blood samples with measurement of allergen specific blocking IgG4 antibodies	Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).