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Study on the Effectiveness and Safety of a Grass and Olive Pollen Allergy Vaccine for Patients with Allergic Rhinitis or 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 can 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 olive pollen, known by the code name MG01_T517. The purpose of the study is to evaluate how well this vaccine works when given as an injection under the skin compared to a placebo.

Participants in the study will receive injections of either the vaccine or a placebo over a period of up to 12 months. The study will monitor the participants' symptoms and any medication they use during the grass and olive tree pollen season, which typically occurs in April, May, and June. The study will also look at the number of days participants are free from symptoms and medication, any worsening of asthma symptoms, and overall quality of life related to rhinitis. Additionally, the study will assess the safety of the vaccine by tracking any side effects or reactions at the injection site.

The trial aims to provide valuable information on whether the vaccine can help reduce symptoms and improve the quality of life for people with allergies to grasses and olive trees. By comparing the vaccine to a placebo, researchers hope to determine its effectiveness in managing these allergic conditions. The study will also gather data on various health measures, including levels of specific antibodies in the blood, to better understand the vaccine's impact on the immune system.

The research process

The trial runs in 6 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 olive tree pollen.

  2. Step 2

    Initial assessment

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

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

  3. Step 3

    Treatment phase

    The patient receives subcutaneous injections of a suspension for injection containing a mixture of modified allergen extracts of 6 grasses and olive pollen.

    The treatment is administered subcutaneously, meaning it is injected under the skin.

  4. Step 4

    Monitoring and recording

    The patient is required to record symptoms and medication use using a smartphone.

    Regular monitoring of symptoms and any adverse reactions is conducted throughout the trial.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the overall symptom and medication score during the grass and olive tree pollen season (April, May, and June).

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

  6. Step 6

    Completion of the trial

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

    Upon completion, the patient's data will be analyzed to assess the efficacy and safety 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 symptoms like sneezing or itchy eyes, caused by grass and olive tree pollen. They may also have mild to moderate asthma that is under control.
  • The person must have a positive skin prick test, which is a test where a small amount of allergen is placed on the skin to see if there is a reaction. The reaction should be to a mix of grass pollen or olive tree pollen.
  • The person must have a specific type of allergy antibody, called IgE, at a certain level in their blood, which shows they are allergic to grass or olive tree pollen.
  • Women who can have children must take a urine pregnancy test and have a negative result when they start the trial.
  • Women who can have children must agree to use a reliable method of birth control during the trial. This can include devices like an intrauterine device (IUD), surgical methods like tubal ligation, barrier methods, or taking birth control pills.
  • The person must be able to follow the schedule for taking the trial medication.
  • The person must have a smartphone to record their symptoms and any medication they take during the trial.
  • The person must not have a positive skin prick test for other common allergens like certain pollens, mites, fungi, or animal dander. If a specific allergy test (IgE) is done, the result should be below a certain level and without significant symptoms.

Who cannot join the trial?

7 criteria

  • Patients who have a severe form of asthma that is not controlled cannot participate. **Controlled asthma** means that the symptoms are managed well with treatment.
  • Individuals with other serious health conditions that could interfere with the study results are not eligible.
  • Pregnant or breastfeeding women are excluded from the trial.
  • Participants who have had a severe allergic reaction to similar treatments in the past cannot join.
  • People who are currently participating in another clinical trial are not allowed to take part in this one.
  • Anyone with a history of drug or alcohol abuse may be excluded.
  • Individuals who are unable to follow the study procedures or attend scheduled visits are not eligible.
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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, sneezing, and itchy eyes. These extracts are given through an injection under the skin. The goal is to see if these allergen extracts can reduce the symptoms in people who are allergic to grasses and olive trees. This treatment is being tested to see if it can help people who also have mild to moderate asthma, which is a condition that affects breathing.

What is already known about the treatment

Polymerized Allergen Extracts – This medication is administered through subcutaneous injections and is currently being studied in clinical trials for its effectiveness and safety. It is primarily used for treating moderate to severe intermittent or persistent allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate allergic asthma. The medication works by gradually desensitizing the immune system to specific allergens, such as grasses and olive tree pollen, reducing allergic reactions. It is classified as an immunotherapy agent, specifically designed to modify the immune response to allergens.

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. The condition can be triggered by allergens like pollen, dust mites, or pet dander. It can be intermittent or persistent, depending on the frequency and duration of exposure to allergens. Over time, symptoms may vary in intensity and can affect daily activities and sleep quality.

  • Allergic Rhinoconjunctivitis

    This disease involves both the nasal passages and the eyes, leading to symptoms such as sneezing, nasal congestion, runny nose, itchy eyes, and tearing. It is caused by an allergic reaction to substances like pollen, dust, or animal dander. The condition can be seasonal or perennial, depending on the allergens involved. Symptoms can fluctuate in severity and may impact daily life and comfort.

  • Allergic Asthma

    This type of asthma is triggered by allergens and is characterized by inflammation and narrowing of the airways. Symptoms include wheezing, coughing, shortness of breath, and chest tightness. It can be intermittent or persistent, with varying degrees of severity. Exposure to allergens such as pollen, dust mites, or pet dander can exacerbate symptoms. Over time, the condition may affect physical activity and overall quality of life.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514525-34-00Protocol codeDMV03-SIT-027Estimated enrolment180 patientsSponsorInmunotek S.L.

sourced from the EU Clinical Trials Register and site verification

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