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Study on the Effectiveness and Safety of a Grass and Juniperus Oxycedrus Allergy Vaccine for Patients with Allergic Rhinitis or Rhinoconjunctivitis with or without Mild Asthma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a new treatment for people with allergic rhinitis or rhinoconjunctivitis, which are conditions that cause symptoms like sneezing, runny nose, and itchy eyes. These conditions may occur with or without mild to moderate asthma, a condition that affects breathing. The treatment being tested is a vaccine made from a mixture of modified allergen extracts from six types of grasses and a plant called Juniperus oxycedrus. This vaccine is given as an injection under the skin. The study will compare the effects of this vaccine to a placebo, which looks like the treatment but does not contain any active ingredients.

The purpose of the study is to evaluate how well the vaccine works in reducing symptoms and the need for medication during the pollen seasons of grasses and cupressaceae, which are types of plants that can cause allergies. Participants will receive the vaccine or placebo over a period of 12 months. Throughout the study, participants will be monitored for any changes in their symptoms, the number of days they are symptom-free, and any asthma flare-ups. The study will also assess the overall safety of the vaccine by tracking any side effects or reactions at the injection site.

Participants will be asked to record their symptoms and medication use using a smartphone app. The study will also measure certain immune system markers, such as total IgE and specific IgG4, which are types of antibodies related to allergies. Additionally, the study will evaluate the participants' quality of life and asthma control using questionnaires. The trial aims to provide valuable information on whether this new vaccine can help people with grass and cupressaceae allergies manage their symptoms more effectively.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have signed the informed consent form.

    The patient should be between 12 and 65 years old and have a confirmed history of inhalation allergy caused by grass and cupressaceae.

  2. Step 2

    Initial assessment

    The patient undergoes an initial assessment to confirm eligibility, including a skin prick test and specific IgE tests.

    Women of childbearing age must present a negative urine pregnancy test.

  3. Step 3

    Treatment phase

    The patient receives a suspension for injection containing a mixture of modified allergen extracts of 6 grasses and Juniperus oxycedrus.

    The injections are administered subcutaneously (under the skin).

    The treatment aims to evaluate the clinical efficacy of the allergen extracts compared to a placebo.

  4. Step 4

    Monitoring and evaluation

    The patient records symptoms and medication consumption using a smartphone.

    The primary endpoint is the overall symptom and medication score during the pollen season of cupressaceae (January, February, and March) and grasses (May and June).

    Secondary endpoints include symptom-free days, medication-free days, asthma exacerbations, and quality of life assessments.

  5. Step 5

    Completion of the trial

    The trial is estimated to end on October 31, 2025.

    The patient will have contributed to the assessment of the safety and efficacy of the treatment.

Who can join the trial?

10 criteria

  • The person must have signed the informed consent form, which means they agree to participate in the study after understanding what it involves.
  • The person can be of any gender and must be between 12 and 65 years old.
  • The person must have a confirmed history of inhalation allergy, which includes moderate to severe symptoms of sneezing, runny nose, or itchy eyes, with or without mild to moderate asthma. This allergy should be due to grass and cupressaceae (a type of plant) and must have been diagnosed at least 12 months before joining the study.
  • The person must have a positive skin test, which is a test that shows a reaction (a bump of 5 mm or more) to a mixture of grass pollen or to one of its components and a cupressaceae extract.
  • The person must have a specific type of allergy antibody (IgE) to grass or cupressaceae, with a value greater than 3.5 KU/L, which indicates a significant allergic reaction.
  • Women who can have children must take a urine pregnancy test and have a negative result when they start the study.
  • Women who can have children must agree to use a reliable method of birth control, such as an intrauterine device, surgical sterilization, barrier methods, or birth control pills.
  • The person must be able to follow the study's schedule for taking the medication.
  • The person must have a smartphone to record their symptoms and any medication they take.
  • The person must have a negative skin test for other common allergens like mites, animal dander, and fungi, meaning they do not react to these allergens.

Who cannot join the trial?

8 criteria

  • Patients with severe asthma that is not well controlled cannot participate. This means if your asthma symptoms are not managed well with your current treatment, you may not be eligible.
  • If you have any other serious health conditions that could interfere with the study, you may be excluded. This includes conditions that require ongoing medical treatment or monitoring.
  • Pregnant or breastfeeding women are not allowed to participate in the study to ensure the safety of both the mother and the baby.
  • Individuals who have had a severe allergic reaction to similar treatments in the past will not be eligible. A severe allergic reaction is a serious response by your body to a substance, which can include symptoms like difficulty breathing or swelling.
  • If you are currently participating in another clinical trial, you cannot join this study. This is to avoid any interference between different treatments or study protocols.
  • Patients who have received certain types of allergy treatments recently may be excluded. This is to ensure that the study results are not affected by previous treatments.
  • Individuals with a history of drug or alcohol abuse may not be eligible. This is because such issues can affect the study's outcomes and participant safety.
  • If you have any condition that, in the opinion of the study doctor, makes it unsafe for you to participate, you may be excluded. This is to protect your health and ensure the study's integrity.
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Investigated drugs

Polymerized Allergen Extracts are used in this clinical trial to help patients with rhinitis or rhinoconjunctivitis, which are conditions that cause symptoms like a runny nose and itchy eyes. These extracts are given as an injection under the skin. The goal is to see if they can reduce symptoms in people who are allergic to grasses and cupressaceae, which are types of plants. The trial also includes patients who have mild to moderate asthma, to see if the treatment helps them as well.

What is already known about the treatment

Polymerized Allergen Extracts – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials to assess its effectiveness and safety for treating moderate to severe intermittent or persistent allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate allergic asthma. The main therapeutic use is to address these allergic conditions by reducing symptoms and improving quality of life. At the molecular level, the medication works by modifying the immune system's response to allergens, potentially leading to increased tolerance. It is classified pharmacologically as an immunotherapy agent.

Investigated diseases

  • Allergic Rhinitis

    This condition is characterized by inflammation of the nasal passages due to an allergic reaction. It often results in symptoms such as sneezing, itching, nasal congestion, and runny nose. Allergic rhinitis can be triggered by allergens like pollen, dust mites, or pet dander. It can be classified as intermittent or persistent, depending on the frequency and duration of symptoms. The severity can range from mild to moderate, affecting daily activities and sleep.

  • Allergic Rhinoconjunctivitis

    This disease involves both the nasal passages and the eyes, leading to symptoms such as itchy, watery eyes, along with nasal congestion and sneezing. It is caused by exposure to allergens like pollen or dust. The condition can be intermittent or persistent, depending on how often symptoms occur. It can significantly impact quality of life, causing discomfort and affecting daily activities. The severity can vary, with some individuals experiencing mild symptoms and others having more severe reactions.

  • Allergic Asthma

    This type of asthma is triggered by allergens such as pollen, dust mites, or pet dander. It causes inflammation and narrowing of the airways, leading to symptoms like wheezing, coughing, shortness of breath, and chest tightness. The condition can be intermittent or persistent, with symptoms ranging from mild to moderate. It often occurs alongside other allergic conditions like rhinitis. Managing exposure to allergens is crucial in controlling symptoms and preventing asthma attacks.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514524-16-00Protocol codeDMV02-SIT-026Estimated enrolment180 patientsSponsorInmunotek S.L.

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