Clinical trial to asses the efficacy and safety of a vaccine for grasses and cupressaceae allergy

Phase 3

Recruiting

• Conditions: Aetiological treatment of moderate-severe intermitent or persistent allergic rhinitis/rhinoconjunctivitis with or without controlled mild-moderate intermittent or persistent allergic asthma

• Registration Number: 2024-514524-16-00
• Lead Sponsor: Inmunotek S.L.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-14
• Last Update Posted: 2025-06-11

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

1. Subject who has signed the informed consent form.

2. 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.

3. 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.

4. Subjects of both sexes aged between 12 and 65 years.

5. 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.

6. 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.

7. 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.

8. Women of childbearing age (from menarche) must present a urine pregnancy test with negative result at the time of entry into the trial.

9. 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.

10. Subjects able to comply with the dosing regimen.

11. Subjects with a smartphone to record symptoms and medication consumption.

Exclusion Criteria

1. Subjects with positive skin prick test to other aeroallergens, except for dander with occasional exposure and symptomatology.

2. Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).

3. 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).

4. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or diagnosed with immunodeficiencies.

5. Subject whose condition prevents him/her from offering cooperation and/or who has severe psychiatric disorders.

6. Subjects with known allergy to components of the investigational medicinal product other than the allergen.

7. Subjects with lower respiratory tract diseases other than asthma such as emphysema or bronchiectasis.

8. Subjects who are immediate family members of investigators.

9. Pregnant or breastfeeding women.

10. Subjects with positive skin prick test for other aeroallergens, except for non-co-seasonal pollens with grasses and cupressaceae.

11. Subjects who have received immunotherapy to pollens in the last 5 years or are currently receiving immunotherapy with any allergen.

12. 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.

13. 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.

14. Subjects who have previously exhibited a severe secondary reaction during diagnostic skin prick test.

15. Subjects on treatment with ß-blockers.

16. Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, febrile process, acute urticaria, etc.).

17. 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.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS) during the pollen season and pollen peak of cupressaceae (January, February and March) and grasses (May and June).		Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS) during the pollen season and pollen peak of cupressaceae (January, February and March) and grasses (May and June).

Secondary Outcome Measures

Name	Time	Method
Symptom free days in rhinitis/rhinoconjunctivitis and asthma		Symptom free days in rhinitis/rhinoconjunctivitis and asthma
Medication-free days in rhinitis/rhinoconjunctivitis and asthma		Medication-free days in rhinitis/rhinoconjunctivitis and asthma
Symptom score in rhinitis/rhinoconjunctivitis (RSS) during pollen season and pollen peak of grasses and cupressaceae.		Symptom score in rhinitis/rhinoconjunctivitis (RSS) during pollen season and pollen peak of grasses and cupressaceae.
Medication score in rhinitis/rhinoconjunctivitis (RMS) during pollen season and pollen peak of grasses and cupressaceae.		Medication score in rhinitis/rhinoconjunctivitis (RMS) during pollen season and pollen peak of grasses and cupressaceae.
Combined symptom and medication score (ACSMS) during pollen season and pollen peak of grasses and cupressaceae.		Combined symptom and medication score (ACSMS) during pollen season and pollen peak of grasses and cupressaceae.
Asthma symptom score (ASS) during pollen season and pollen peak of grasses and cupressaceae.		Asthma symptom score (ASS) during pollen season and pollen peak of grasses and cupressaceae.
Asthma Medication Score (AMS) during pollen season and pollen peak of grasses and cupressaceae.		Asthma Medication Score (AMS) during pollen season and pollen peak of grasses and cupressaceae.
Asthma and rhinitis/rhinoconjunctivitis symptom score (ARSS) during pollen season and pollen peak of grasses and cupressaceae.		Asthma and rhinitis/rhinoconjunctivitis symptom score (ARSS) during pollen season and pollen peak of grasses and cupressaceae.
Asthma and rhinitis/rhinoconjunctivitis medication score (ARMS) during pollen season and pollen peak of grasses and cupressaceae		Asthma and rhinitis/rhinoconjunctivitis medication score (ARMS) during pollen season and pollen peak of grasses and cupressaceae
Combined symptom and medication score in asthma and rhinitis/rhinoconjunctivitis (ARCSMS) during pollen season and pollen peak of grasses and cupressaceae.		Combined symptom and medication score in asthma and rhinitis/rhinoconjunctivitis (ARCSMS) during pollen season and pollen peak of grasses and cupressaceae.
Asthmatic exacerbations: time to first occurrence of asthmatic exacerbation, number, duration and severity.		Asthmatic exacerbations: time to first occurrence of asthmatic exacerbation, number, duration and severity.
Visual Analogue Scale (VAS)		Visual Analogue Scale (VAS)
Immunological parameters (total IgE, specific IgE and specific IgG4).		Immunological parameters (total IgE, specific IgE and specific IgG4).
Asthma Control Questionnaire (ACQ-6).		Asthma Control Questionnaire (ACQ-6).
Rhinitis Follow-up Questionnaire (ESPRINT-15).		Rhinitis Follow-up Questionnaire (ESPRINT-15).
Register of consumption of health resources.		Register of consumption of health resources.
Safety of specific immunotherapy (Overall rate, severity, and ratio of any adverse event (AE) by administration and by subject; Evaluation of administration site reactions, systemic reactions and any medication administered for the treatment of AE)		Safety of specific immunotherapy (Overall rate, severity, and ratio of any adverse event (AE) by administration and by subject; Evaluation of administration site reactions, systemic reactions and any medication administered for the treatment of AE)

Trial Locations

Locations (19)

Hospital Universitario Infanta Elena; 🇪🇸 Madrid, Spain

Hospital De Valladolid Felipe II; 🇪🇸 Valladolid, Spain

Clínica subiza S.A.; 🇪🇸 Madrid, Spain

Hospital Universitario Fundacion Alcorcon; 🇪🇸 Madrid, Spain

Hospital Universitario De Salamanca; 🇪🇸 Salamanca, Spain

Hospital Central De La Cruz Roja San Jose Y Santa Adela; 🇪🇸 Madrid, Spain

Hospital Universitario Ramon Y Cajal; 🇪🇸 Madrid, Spain

Centro médico Saluddia; 🇪🇸 Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Clínica privada Dra Leanizbarrutia; 🇪🇸 Palencia, Spain

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Hospital Universitario Infanta Elena

🇪🇸Madrid, Spain

Francisco Javier Ruiz

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jrornillod@gmail.com