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Safety and Efficacy Study of Intralymphatic Allergen-specific Immunotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02423707
Recruitment Status : Completed
First Posted : April 22, 2015
Last Update Posted : August 20, 2018
Sponsor:
Collaborators:
Skane University Hospital
Karolinska University Hospital
Information provided by (Responsible Party):
Lars Olaf Cardell, Karolinska Institutet

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)


Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: ALK Alutard Birch and/or 5-grasses Drug: ALK Diluent Phase 2 Phase 3

Detailed Description:

In the first part of the study safety and clinical efficacy of ALK Alutard Birch or 5-grass have been evaluated in a RCT with 50 patients. Active patients recieve 3 injections with 1000 SQ-U ALK Alutard or 5-grasses in a lymph node in the groin. Dose interval 4 weeks. This part of the study is completed and published (PMID: 23374268)

In the second part of the study 60 patients participates in a RCT with intralymphatic injections with both ALK Alutard Birch AND ALK Alutard 5-grasses. The injections are given intralymphatically with one allergen in each groin with 30 minutes observation between injections. Dose and dose interval are the same as in the first part of the study; the active group recieves 1000 SQ-U ALK Alutard Birch in right groin and 1000 SQ-U 5-grasses in left groin. The injections are given 3 times with 4 weeks interval. Enrollment and treatment is completed and the results will be evaluated in the autumn 2015.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intralymphatic Allergen-specific Immunity as a New Administration Route for Treatment of Pollen-induced Allergic Diseases
Study Start Date : August 2010
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: ALK Alutard Birch and/or 5-grasses
3 intralymphatic injections with dose 1000 SQ-U and dose interval 4 weeks.
Drug: ALK Alutard Birch and/or 5-grasses

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.

Other Name: ALK Alutard Betula Verrucosa and ALK Alutard 5-grasses

Placebo Comparator: ALK diluent
3 intralymphatic injections with dose interval 4 weeks.
Drug: ALK Diluent
This placebo group will receive 3 injections of 0.3% human albumin instead of active substance
Other Name: Human albumin




Primary Outcome Measures :
  1. Change in subjective allergic symptoms following nasal allergen provocation [ Time Frame: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment. ]
    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.


Secondary Outcome Measures :
  1. Registration of adverse event [ Time Frame: from the first injection to 30 days after the last injections has been given ]
  2. Effects on quality of life [ Time Frame: During peak pollen season which will be up to 5 months (birch) and 6 months (grass) after completed treatment ]
    SNOT-22 questionnaire

  3. Effects on quality of life [ Time Frame: During peak pollen season which will be up to 5 months (birch) and 6 months (grass) after completed treatment ]
    Juniper RQLQ questionnaires

  4. Change in medicine consumption during pollen season [ Time Frame: 6-9 months after treatment. ]
    After the pollen season patients report to what extension they have been using medications; more, the same or less. The mediacations asked about are antihistamine tablets, antihistamine eye drops, nasal steroid, steroid tablets, b2-bronchodilator inhalation, leucotrien receptor antagonist, nasal or ocular sodium chromoglycates.

  5. Change in symptoms at pollen season [ Time Frame: 6-9 months after treatment. ]
    After the pollen season at the 6-9 months follow up patients recall the pollen season and rates the improvement on an arbitrary scale ranging 0-10 with 0 as "no improvement at all" and 10 "total symptom relief".

  6. Short term improvement of skin reactivity [ Time Frame: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment. ]
    Skin prick test

  7. S-IgE Birch [ Time Frame: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment ]
  8. S-IgE Grass [ Time Frame: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment ]
  9. S-IgG4 Grass [ Time Frame: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment ]
  10. S-IgG4 Birch [ Time Frame: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 β-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423707


Locations
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Sweden
Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Malmö
Malmö, Sweden, 20502
Sponsors and Collaborators
Karolinska Institutet
Skane University Hospital
Karolinska University Hospital
Investigators
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Principal Investigator: Lars-Olaf Cardell, Prof Karolinska Institutet
Publications:
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Responsible Party: Lars Olaf Cardell, Professor, Head of Division, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02423707    
Other Study ID Numbers: 2009-016815-39
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases