Mechanisms of Allergen Immunotherapy

This study has been terminated.
(R and D approval not forthcoming)
Sponsor:
Information provided by (Responsible Party):
Nicola Gray, Royal Sussex County Hospital
ClinicalTrials.gov Identifier:
NCT01523158
First received: January 27, 2012
Last updated: September 21, 2012
Last verified: September 2012

January 27, 2012
September 21, 2012
April 2012
June 2015   (final data collection date for primary outcome measure)
What are the changes in T cells associated with immunotherapy? [ Time Frame: 6 months ] [ Designated as safety issue: No ]
How does the T cell response change after immunotherapy
Same as current
Complete list of historical versions of study NCT01523158 on ClinicalTrials.gov Archive Site
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Mechanisms of Allergen Immunotherapy
An Open Study to Investigate the Effects of Injection Immunotherapy on Allergen-specific T and B Cell Responses in Adult Patients With Seasonal Allergic Rhinitis.

Hay fever (seasonal allergic rhinitis) results from allergy to grass and tree pollen. The majority of affected individuals manage well with medication from the Pharmacy or from their general practitioner (GP), but for some severely affected people it severely impacts on quality of life. Less than 40% of those affected in UK general practice feel that these medications achieve good symptomatic control.

Specific immunotherapy or desensitisation is the practice of administering small amounts of allergen to allergic patients in increasing doses. This treatment is highly effective in these patients and furthermore is truly disease-modifying, with benefits persisting long-term, even when the treatment has been completed. Desensitisation is a routine treatment in the UK, Europe and North America. The exact immune mechanisms that underlie this symptomatic improvement are not entirely clear. Dr Tarzi, Professor Frew and Professor Kern have recently developed new methods for the investigation of immune responses to allergens. These methods require relatively small blood samples and may provide useful information about how immunotherapy exerts its effects. In addition to improving the investigators basic understanding of this treatment, such knowledge may drive improvements in the treatment and could be useful for monitoring patients for response. The investigators study proposes to investigate changes in the immune responses to pollen allergens during immunotherapy. Blood will be taken just prior to the first immunotherapy injection and again just prior to the final injection. In this way the investigators will be able to compare the immune responses to pollen allergen before and after treatment.

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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Allergic Rhinitis
Biological: Allergovit grass or birch
subcutaneous injection of immunotherapy once weekly for 7 weeks prior to birch pollen season.
Immunotherapy
Open label study of changes to cellular responses following immunotherapy
Intervention: Biological: Allergovit grass or birch
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
September 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female
  • Age 18 with no upper age limit
  • History of seasonal rhino-conjunctivitis in the appropriate season, not controlled by optimised standard medical therapy
  • Positive skin prick test to grass pollen or tree pollen

Exclusion Criteria:

  • Inadequately controlled or moderate to severe asthma (GINA III/IV), i.e. the FEV1 is below 70 % of the target value despite adequate pharmacotherapy
  • Irreversible changes in the reaction organ (emphysema, bronchiectasis, etc.)
  • Clinically significant cardiovascular insufficiency (in cardiovascular diseases, there is an elevated risk of adverse reactions to adrenaline)
  • Local or systemic use of beta blockers
  • Diseases of the immune system (autoimmune diseases, immune complex-induced immunopathies, immunodeficiencies etc.)
  • Malignant disease within the past five years (Patients with previous malignant disease that is considered cured may be included subject to the consent of their oncologist)
  • Inability to attend regularly for injections and follow-up visits
  • Severe atopic dermatitis
  • Pregnant or not using adequate contraception (post-menopausal, surgically sterilised, long-term abstinent, or barrier methods plus spermicide)
  • Breast-feeding
  • Evidence of current drug or alcohol misuse
  • Hypersensitivity to any of the SIT (immunotherapy product) excipients
  • Active tuberculosis
  • Severe mental disorders
  • Multiple sclerosis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01523158
12/014/TAR
No
Nicola Gray, Royal Sussex County Hospital
Royal Sussex County Hospital
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Royal Sussex County Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP