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Clinical trial to asses the efficacy and safety of a vaccine for grasses and cupressaceae allergy
EU CTIS ID: 2024-514524-16-00
What this study is testing
The main objective of this clinical trial is to evaluate the clinical efficacy of subcutaneously administered polymerized allergen extracts compared to placebo in subjects with rhinitis/rhinoconjunctivitis according to the ARIA classification, with or without controlled intermittent or persistent (mild-moderate) asthma, as defined by GEMA 5.0 during pollen season and pollen peak of grasses and cupressaceae.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Subject who has signed the informed consent form.
- 10. Subjects with negative skin test for co-seasonal pollens. In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs.
- 11. Subjects with negative skin test for other aeroallergens (mites, dander, and fungi). In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs.
- 2. Subjects of both sexes aged between 12 and 65 years.
- 3. Subjects with a confirmed clinical history of inhalation allergy (moderate-severe intermittent or persistent rhinitis and/or rhinoconjunctivitis according to the ARIA classification, with or without mild-moderate controlled intermittent or persistent asthma according to the GEMA 5.0 classification) caused by grass and cupressaceae allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.
- 4. Subjects with a positive skin prick test (wheal major diameter ≥ 5 mm) to a standardised extract mixture of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or to one of the components of the mixture and a cupressaceae extract. In addition, the wheal major diameter must be greater than or equal to that of the histamine.
You likely can't join if
- 1. Subjects with positive skin prick test to other aeroallergens, except for dander with occasional exposure and symptomatology.
- 10. Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).
- 11. Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, malformations, multiple surgeries, nephropathies).
- 12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or diagnosed with immunodeficiencies.
- 13. Subject whose condition prevents him/her from offering cooperation and/or who has severe psychiatric disorders.
- 14. Subjects with known allergy to components of the investigational medicinal product other than the allergen.
See the full eligibility criteria
Who can join
- 1. Subject who has signed the informed consent form.
- 10. Subjects with negative skin test for co-seasonal pollens. In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs.
- 11. Subjects with negative skin test for other aeroallergens (mites, dander, and fungi). In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs.
- 2. Subjects of both sexes aged between 12 and 65 years.
- 3. Subjects with a confirmed clinical history of inhalation allergy (moderate-severe intermittent or persistent rhinitis and/or rhinoconjunctivitis according to the ARIA classification, with or without mild-moderate controlled intermittent or persistent asthma according to the GEMA 5.0 classification) caused by grass and cupressaceae allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.
- 4. Subjects with a positive skin prick test (wheal major diameter ≥ 5 mm) to a standardised extract mixture of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or to one of the components of the mixture and a cupressaceae extract. In addition, the wheal major diameter must be greater than or equal to that of the histamine.
- 5. Specific IgE (CAP or Immulite) to a grass mixture or to one of the components of the grass mixture, preferably to Phleum pratense and cupressaceae or to one of the molecular components of the allergenic sources with a value > 3.5 KU/L.
- 6. Women of childbearing age (from menarche) must present a urine pregnancy test with negative result at the time of entry into the trial.
- 7. Women of childbearing age participating in the trial must agree to use an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices inserted at least 3 months in advance, surgical sterilisation (e.g., tubal ligations), barrier methods, or the use of oral contraceptives.
- 8. Subjects able to comply with the dosing regimen.
- 9. Subjects with a smartphone to record symptoms and medication consumption.
What rules you out
- 1. Subjects with positive skin prick test to other aeroallergens, except for dander with occasional exposure and symptomatology.
- 10. Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).
- 11. Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, malformations, multiple surgeries, nephropathies).
- 12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or diagnosed with immunodeficiencies.
- 13. Subject whose condition prevents him/her from offering cooperation and/or who has severe psychiatric disorders.
- 14. Subjects with known allergy to components of the investigational medicinal product other than the allergen.
- 15. Subjects with lower respiratory tract diseases other than asthma such as emphysema or bronchiectasis.
- 16. Subjects who are immediate family members of investigators.
- 17. Pregnant or breastfeeding women.
- 2. Subjects with positive skin prick test for other aeroallergens, except for non-co-seasonal pollens with grasses and cupressaceae.
- 3. Subjects who have received immunotherapy to pollens in the last 5 years or are currently receiving immunotherapy with any allergen.
- 4. Subjects in whom immunotherapy may be subject to absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee.
- 5. Subjects with severe or uncontrolled persistent asthma, with an FEV1<70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial. Also subjects with intermittent or persistent rhinitis/rhinoconjunctivitis with severe symptoms in whom discontinuation of oral or systemic antihistamine treatment is contraindicated.
- 6. Subjects who have previously exhibited a severe secondary reaction during diagnostic skin prick test.
- 7. Subjects on treatment with ß-blockers.
- 8. Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, febrile process, acute urticaria, etc.).
- 9. Subjects with chronic active urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin prick test will be performed, or a history of hereditary angioedema.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.