Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy
- Conditions
- RhinitisRhinoconjunctivitis
- Interventions
- Biological: MG56 Mannosylated 500 subcutaneousBiological: MG56 Mannosylated 5000 sublingualBiological: MG56 Mannosylated 5000 subcutaneousBiological: MG56 Mannosylated 500 sublingualBiological: MG56 Mannosylated 1000 subcutaneousBiological: MG56 Mannosylated 3000 subcutaneousBiological: MG56 Mannosylated 3000 sublingualBiological: MG56 Mannosylated 1000 sublingualBiological: Subcutaneous placeboBiological: Sublingual placebo
- Registration Number
- NCT02654223
- Lead Sponsor
- Inmunotek S.L.
- Brief Summary
The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against grass pollen allergy
- Detailed Description
Double blind placebo-controlled study. The subjects will receive medication during 4 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- Written informed consent
- Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate asthma, due to grass pollen allergy
- Subjects with a positive skin prick-test (wheal sixe >6 mm diameter) Specific immunoglobulin E (IgE, CAP >3) to grass pollen
- Age between 14 and 65 years
- Both genders
- Subjects capable of giving informed consent
- Subjects capable of complying with the dosing regimen
- Subjects that have not received immunotherapy in the last 5 years
- Subjects presenting sensitization to another aeroallergens and or mites, cats or dogs, but that is considered clinically not relevant or no clinical interference with the nasal provocation test.
- Subjects outside of the age range.
- Subjects who have previously received immunotherapy for the treatment of the allergic rhinitis/rhinoconjunctivitis due to grass pollen and other allergens in the last 5 years.
- Subjects that immunotherapy may be an absolute contraindication according to the criteria of the immunotherapy Committee of the Spanish society of Allergy and Clinical Immunology, and of the European Allergy and Clinical Immunology Immunotherapy Subcommittee may also include.
- Subjects with important symptoms of rhinoconjunctivitis /bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
- Subjects with persistent severe or not controlled asthma , with a forced expiratory volume (FEV) < 70 respect to the reference value in spite of the appropriate pharmacological treatment at the time of the inclusion in the trial.
- Subjects that have required oral corticosteroids in the 12 weeks previous to the inclusion in the trial.
- Subjects that have previously submitted a serious secondary reaction during the skin prick test
- Subjects in treatment with beta blockers.
- Unstable subjects from the clinical point of view (respiratory infection, febrile, acute urticaria, etc.) at the time of the inclusion in the clinical trial
- Subject with chronic urticaria in the last 2 years or hereditary angioedema.
- Subjects that have some pathology (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated.
- Subjects with any other disease not associated with the rhinitis/rhinoconjunctivitis, but of potential severity and that could interfere with treatment and follow-up (epilepsy, psychomotor deterioration, diabetes, malformations, multi-operated, kidney diseases,...).
- Subjects with autoimmune disease (lupus, thyroiditis, etc.), tumor or with diagnosis of immunodeficiency diseases.
- Subject whose status prevents him from providing cooperation and or which present severe psychiatric disorders.
- Subject with known allergy to other components of the vaccine different from pollen of grasses.
- Subjects with lower airway diseases other than asthma such as emphysema or bronchiectasis.
- Direct investigator's relatives.
- Pregnant or women at risk of pregnancy and breastfeeding women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MG56 Mannosylated 500 sublingual Subcutaneous placebo 500 mTU/mL of sublingual immunotherapy and subcutaneous placebo. MG56 Mannosylated 3000 sublingual Subcutaneous placebo 3000 mTU/mL of sublingual immunotherapy and subcutaneous placebo. MG56 Mannosylated 1000 sublingual Subcutaneous placebo 1000 mTU/mL of sublingual immunotherapy and subcutaneous placebo. MG56 Mannosylated 500 subcutaneous MG56 Mannosylated 500 subcutaneous 500 mTU/mL of subcutaneous immunotherapy and sublingual placebo. MG56 Mannosylated 1000 subcutaneous Sublingual placebo 1000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. MG56 Mannosylated 5000 sublingual MG56 Mannosylated 5000 sublingual 5000 mTU/mL of sublingual immunotherapy and subcutaneous placebo. MG56 Mannosylated 5000 subcutaneous MG56 Mannosylated 5000 subcutaneous 5000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. MG56 Mannosylated 500 sublingual MG56 Mannosylated 500 sublingual 500 mTU/mL of sublingual immunotherapy and subcutaneous placebo. MG56 Mannosylated 1000 subcutaneous MG56 Mannosylated 1000 subcutaneous 1000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. MG56 Mannosylated 3000 subcutaneous MG56 Mannosylated 3000 subcutaneous 3000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. MG56 Mannosylated 500 subcutaneous Sublingual placebo 500 mTU/mL of subcutaneous immunotherapy and sublingual placebo. MG56 Mannosylated 3000 subcutaneous Sublingual placebo 3000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. Placebo Sublingual Placebo subcutaneous Sublingual placebo Sublingual and subcutaneous placebo. MG56 Mannosylated 3000 sublingual MG56 Mannosylated 3000 sublingual 3000 mTU/mL of sublingual immunotherapy and subcutaneous placebo. MG56 Mannosylated 5000 subcutaneous Sublingual placebo 5000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. MG56 Mannosylated 1000 sublingual MG56 Mannosylated 1000 sublingual 1000 mTU/mL of sublingual immunotherapy and subcutaneous placebo. MG56 Mannosylated 5000 sublingual Subcutaneous placebo 5000 mTU/mL of sublingual immunotherapy and subcutaneous placebo. Placebo Sublingual Placebo subcutaneous Subcutaneous placebo Sublingual and subcutaneous placebo.
- Primary Outcome Measures
Name Time Method Concentration required to elicit a positive response after nasal provocation test (NPT) 4 months Change in the threshold concentration of grass allergen extract, measured in Histamine Equivalent Prick per ml (HEP/ml), needed to trigger a positive response after nasal provocation test (NPT) assessed by acoustic rhinometry.
This will be compared between the beginning and end of the trial and among active groups and placebo.
- Secondary Outcome Measures
Name Time Method Phenotypic and functional analysis of dendritic cells 4 months Will be analyzed changes in the frequency of plasmacytoid dendritic cells, myeloid dendritic cell and Treg cells in peripheral blood, between the beginning and end of the trial and among active groups and placebo
The frequencies of peripheral blood mononuclear cells in each of the above populations is determined before and after treatment with mannosylated polymers by flow cytometry after staining with specific antibodies.Dose finding skin prick test 4 months Comparison between the beginning and end of the trial and among active groups and placebo
Cytokine production by T cells specific allergen 4 months Comparison between the beginning and end of the trial and among active groups and placebo
Immunoglobulin production by B cells specific allergen 4 months Comparison between the beginning and end of the trial and among active groups and placebo
Number of participants with treatment-related adverse events as assessed by MG56-SIT-012 4 months Comparison between the beginning and end of the trial and among active groups and placebo
Trial Locations
- Locations (12)
Hospital Nisa Aljarafe
🇪🇸Castilleja De La Cuesta, Sevilla, Spain
Hospital San Agustín
🇪🇸Dos Hermanas, Sevilla, Spain
Clínica Atlas
🇪🇸Aranjuez, Madrid, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario Infanta Elena
🇪🇸Valdemoro, Madrid, Spain
Hospital Viamed Santa Angola de la Cruz
🇪🇸Sevilla, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Clínica Alianza Médica
🇪🇸Valladolid, Spain
CLÍNICA Dr. SUBIZA
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
HOSPITAL UNIVERSITARIO 12 de OCTUBRE
🇪🇸Madrid, Spain
Clínica Ojeda
🇪🇸Madrid, Spain