Safety and Efficacy Study of Intralymphatic Allergen-specific Immunotherapy

NCT02423707 | Completed Phase 2

• 1 other identifier: 2009-016815-39
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Allergen-specific immunotherapy (ASIT) is commonly used to treat patients with allergic rhino-conjunctivitis and asthma, and it is the only proven treatment that affects the long-term development of allergic rhinitis and asthma. The current treatment regime of ASIT requires numerous subcutaneous allergen injections and takes several years to complete. Hence, there is a need to develop more convenient protocols for induction of allergen tolerance. Emerging evidence suggest that by targeting of antigen presenting cells within the lymph nodes the immunogenicity of the allergen can be enhanced and the number of injections can be reduced. The purpose of this study is to evaluate whether intralymphatic administration of ASIT 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 investigators will make an attempt to reproduce the results of a recent human study of intralymphatic ASIT (clinicaltrials.gov; NCT00470457) in a Swedish clinical setting. The first part of the study is completed and published (PMID: 23374268)

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change in subjective allergic symptoms following nasal allergen provocation

  The study subjects will be intranasally challenged with allergen and symptom score questionnaires are filled out pre-provocation and 5, 10 and 30 min post-provocation.

  Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.

Secondary Outcomes (10)

• Registration of adverse event

  from the first injection to 30 days after the last injections has been given

• Effects on quality of life

  During peak pollen season which will be up to 5 months (birch) and 6 months (grass) after completed treatment

• Effects on quality of life

  During peak pollen season which will be up to 5 months (birch) and 6 months (grass) after completed treatment

• Change in medicine consumption during pollen season

  6-9 months after treatment.

• Change in symptoms at pollen season

  6-9 months after treatment.

Study Arms (2)

ALK Alutard Birch and/or 5-grasses

ACTIVE COMPARATOR

3 intralymphatic injections with dose 1000 SQ-U and dose interval 4 weeks.

Drug: ALK Alutard Birch and/or 5-grasses

ALK diluent

PLACEBO COMPARATOR

3 intralymphatic injections with dose interval 4 weeks.

Drug: ALK Diluent

Interventions

ALK Alutard Birch and/or 5-grasses DRUG

3 intralymphatic injections of 1000 SQ-U birch and/or grass allergen with 4 weeks interval. The substance used for the three intralymphatic injections is ALK-alutard SQ Betula verrucosa® and ALK-alutard SQ 5-grasses ® under ATC-code V01AA, V04CL and V07AB which is a depot formulation for subcutaneous use.

Also known as: ALK Alutard Betula Verrucosa and ALK Alutard 5-grasses

ALK Alutard Birch and/or 5-grasses

ALK Diluent DRUG

This placebo group will receive 3 injections of 0.3% human albumin instead of active substance

Also known as: Human albumin

ALK diluent

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50,
• Seasonal allergic symptoms for birch and/or grass verified by skin prick test,
• Accepted informed consent

You may not qualify if:

• 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 β-blockers)
• Major metabolic disease
• Known or suspected allergy to the study product
• Alcohol or drug abuse

Sponsors & Collaborators

• Karolinska Institutet: lead
• Skane University Hospital: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Malmö

Malmo, 20502, Sweden

Location

Related Publications (1)

• 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.

  PMID: 19001265 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Serum Albumin, Human

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• Lars-Olaf Cardell, Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Division, MD

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 22, 2015
• Study Start: August 1, 2010
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2017
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

SE (1)