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Holcus Lanatus Pollen Allergoid, Glutaraldehyde-Modified

This article discusses recent clinical trials investigating the use of Holcus Lanatus Pollen Allergoid, a modified allergen extract, as part of immunotherapy treatments for patients suffering from allergic rhinitis, rhinoconjunctivitis, and mild to moderate asthma. These trials aim to assess the efficacy and safety of subcutaneous immunotherapy using this allergoid in combination with other grass and tree pollen extracts.

Table of Contents

What is Holcus Lanatus Pollen Allergoid?

Holcus Lanatus Pollen Allergoid is a component of an innovative allergy vaccine designed to treat allergies caused by grass and tree pollens. This medication is part of a mixture that includes modified allergen extracts from various grass species and tree pollens. The term “allergoid” means that the allergen has been chemically modified to reduce its ability to cause allergic reactions while still maintaining its therapeutic effects[1].

The full name of this treatment is “Mixture of modified allergen extracts of 6 grasses (MG01) and modified allergen extract of Juniperus oxycedrus (T521) or olive pollen (T517).” It contains the following components:

  • Holcus lanatus (Yorkshire fog grass) pollen allergoid
  • Phleum pratense (Timothy grass) pollen allergoid
  • Festuca pratensis (Meadow fescue) pollen allergoid
  • Poa pratensis (Kentucky bluegrass) pollen allergoid
  • Dactylis glomerata (Orchard grass) pollen allergoid
  • Lolium perenne (Perennial ryegrass) pollen allergoid
  • Either Juniperus oxycedrus (Prickly juniper) or Olea europaea (Olive tree) pollen allergoid

Medical Conditions Treated

This allergy vaccine is designed to treat the following conditions[1][2]:

  • Allergic rhinitis: An inflammation of the nasal passages caused by an allergic reaction to pollen, resulting in symptoms like sneezing, runny nose, and nasal congestion.
  • Allergic rhinoconjunctivitis: A condition that affects both the nose and eyes, causing symptoms such as itchy, watery eyes in addition to nasal symptoms.
  • Mild to moderate allergic asthma: Breathing difficulties triggered by an allergic reaction to pollen.

The treatment is specifically targeted at individuals with moderate to severe intermittent or persistent forms of these conditions.

How It Works

This allergy vaccine works through a process called immunotherapy. Here’s how it functions[1]:

  1. The allergoids in the vaccine are modified versions of the actual allergens that cause your allergic reactions.
  2. When introduced into your body in small, controlled doses, these allergoids help your immune system become less sensitive to the real allergens.
  3. Over time, this can lead to a reduction in allergic symptoms when you’re exposed to grass or tree pollen in your environment.

This approach is known as subcutaneous immunotherapy (SCIT), as the vaccine is administered via injection under the skin.

Administration and Dosage

The Holcus Lanatus Pollen Allergoid vaccine is administered as follows[1][2]:

  • It is given as a subcutaneous injection, which means it’s injected just under the skin.
  • The maximum daily dose is 0.5 ml.
  • The treatment period can last up to 12 months.

It’s important to note that this medication should only be administered by healthcare professionals trained in the management of allergic reactions.

Clinical Trials and Efficacy

Clinical trials are currently underway to evaluate the effectiveness and safety of this allergy vaccine. These trials are designed as prospective, multicentre, randomized, double-blind, and placebo-controlled studies[1][2].

The main objective of these trials is to assess:

  • The clinical efficacy of the vaccine compared to a placebo
  • The overall symptom and medication scores during pollen seasons
  • The number of symptom-free and medication-free days
  • Changes in quality of life
  • Changes in immunological parameters (like specific IgE and IgG4 levels)

Results from these trials will provide more concrete evidence about the effectiveness of this treatment in managing grass and tree pollen allergies.

Safety and Side Effects

While the full safety profile is still being evaluated in clinical trials, potential side effects may include[1][2]:

  • Local reactions at the injection site
  • Mild allergic reactions

The trials are carefully monitoring for any adverse events, including severe allergic reactions. It’s important to note that this treatment is designed to be safer than traditional allergen extracts due to the modification process of the allergoids.

Who Can Use This Treatment?

This allergy vaccine is being studied for use in patients aged 12 to 65 years old who have[1][2]:

  • A confirmed history of allergic reactions to grass and specific tree pollens
  • Moderate to severe allergic rhinitis or rhinoconjunctivitis
  • With or without mild to moderate controlled asthma
  • Positive skin prick tests or specific IgE tests for the relevant pollens

However, this treatment may not be suitable for everyone. People with severe uncontrolled asthma, certain autoimmune diseases, or those who are pregnant or breastfeeding may not be eligible for this treatment. Always consult with your allergist or healthcare provider to determine if this treatment is appropriate for you.

Aspect Details
Study Type Phase III clinical trials
Design Prospective, multicentre, randomized, double-blind, placebo-controlled
Main Treatment Subcutaneous immunotherapy with polymerized allergen extracts including Holcus Lanatus Pollen Allergoid
Target Conditions Moderate-severe intermittent or persistent allergic rhinitis/rhinoconjunctivitis with or without controlled mild-moderate intermittent or persistent asthma
Age Range 12-65 years
Primary Endpoint Overall symptom and medication score during relevant pollen seasons
Secondary Endpoints Symptom-free days, medication-free days, asthma exacerbations, quality of life, immunological parameters, safety
Treatment Duration Up to 12 months
Maximum Daily Dose 0.5 ml

FAQ

  • What is Holcus Lanatus Pollen Allergoid? Holcus Lanatus Pollen Allergoid is a modified allergen extract derived from the pollen of Holcus lanatus (velvet grass). It is chemically altered using glutaraldehyde to reduce its allergenicity while maintaining its ability to stimulate the immune system.
  • What conditions are being treated in these clinical trials? The clinical trials are focusing on treating moderate to severe intermittent or persistent allergic rhinitis and rhinoconjunctivitis, with or without controlled mild to moderate intermittent or persistent asthma.
  • How is the treatment administered? The treatment is administered through subcutaneous injections, which means it is injected under the skin.
  • What other allergens are combined with Holcus Lanatus Pollen Allergoid in these trials? In these trials, Holcus Lanatus Pollen Allergoid is combined with other grass pollen extracts (such as Phleum pratense, Dactylis glomerata, Poa pratensis, Festuca elatior, and Lolium perenne) and tree pollen extracts (either Juniperus oxycedrus or Olea europaea).
  • What are the main objectives of these clinical trials? The main objectives are to evaluate the clinical efficacy and safety of the subcutaneously administered polymerized allergen extracts compared to placebo in treating allergic rhinitis, rhinoconjunctivitis, and mild to moderate asthma.

Ongoing Clinical Trials on Holcus Lanatus Pollen Allergoid, Glutaraldehyde-Modified

  • 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

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Effectiveness and Safety of a Grass and Olive Pollen Allergy Vaccine for Patients with Allergic Rhinitis or Asthma

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Allergoid: A modified form of an allergen that has been chemically altered to reduce its ability to cause allergic reactions while still stimulating the immune system.
  • Subcutaneous immunotherapy: A treatment method where allergen extracts are injected under the skin to help the body build tolerance to specific allergens over time.
  • Rhinitis: Inflammation of the nasal passages, often resulting in symptoms such as sneezing, runny nose, and nasal congestion.
  • Rhinoconjunctivitis: A condition characterized by inflammation of both the nasal passages and the conjunctiva (the membrane covering the white part of the eye), typically causing symptoms in both the nose and eyes.
  • ARIA classification: Allergic Rhinitis and its Impact on Asthma (ARIA) is a system used to classify the severity and duration of allergic rhinitis symptoms.
  • GEMA 5.0: Spanish Guidelines for Asthma Management, version 5.0, which provides criteria for classifying and managing asthma.
  • Polymerized allergen extracts: Allergen extracts that have been chemically modified to form larger molecules (polymers), which can reduce allergenicity while maintaining immunogenicity.
  • Placebo: An inactive substance or treatment used in clinical trials as a control to compare against the effects of the active treatment being studied.
  • FEV1: Forced Expiratory Volume in 1 second, a measure of lung function used to assess the severity of asthma.
  • Specific IgE: Immunoglobulin E antibodies that are specific to a particular allergen, measured to determine allergic sensitization.

References

  1. http://clinicaltrials.eu/trial/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/
  2. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-a-grass-and-olive-pollen-allergy-vaccine-for-patients-with-allergic-rhinitis-or-asthma/