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Betula Pendula Pollen Allergoid, Mannan-Conjugated, Polymerised

This article discusses clinical trials investigating the use of Betula Pendula Pollen Allergoid, Mannan-Conjugated, Polymerised (also known as T502) for treating birch pollen-induced allergic rhinitis and rhinoconjunctivitis. These trials aim to assess the effectiveness and safety of this subcutaneously administered treatment in adolescents and adults suffering from these allergic conditions. The studies are designed to compare the active treatment with a placebo to determine its clinical impact during the birch pollen season.

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What is BETULA PENDULA POLLEN ALLERGOID, MANNAN-CONJUGATED, POLYMERISED?

BETULA PENDULA POLLEN ALLERGOID, MANNAN-CONJUGATED, POLYMERISED is an innovative allergy treatment being studied for people with birch pollen allergies[1]. This medication is a type of immunotherapy, which means it aims to train your immune system to be less reactive to birch pollen allergens. The treatment is also known by its product name “Mannan-conjugated allergoid (polymerized) Betula pendula parenteral vaccine” and its sponsor code “EP-088_T502”[2].

How Does It Work?

This treatment works by exposing your immune system to modified birch pollen allergens in a controlled way. The allergens are changed (polymerized) and attached to a substance called mannan. This process aims to make the treatment safer and more effective than exposing you to unmodified birch pollen[1]. By repeatedly exposing your immune system to these modified allergens, the goal is to reduce your allergic reactions when you encounter actual birch pollen in the environment.

What Conditions Does It Treat?

This medication is being studied to treat two main conditions:

  • Allergic rhinitis caused by birch pollen: This is a condition where your nose becomes inflamed due to an allergic reaction to birch pollen, leading to symptoms like sneezing, runny nose, and nasal congestion[1].
  • Allergic rhinoconjunctivitis caused by birch pollen: This condition affects both your nose and eyes, causing symptoms like those mentioned above plus itchy, watery eyes[2].

How is It Administered?

The treatment is given as a subcutaneous injection, which means it’s injected just under your skin[1]. In current clinical trials, patients receive multiple doses over a period of several weeks. The exact dosing schedule and amount may vary depending on the specific study protocol.

Current Clinical Trials

There are ongoing clinical trials to evaluate the safety and effectiveness of this treatment. These studies are designed to determine:

  • How well the treatment reduces allergy symptoms and the need for other allergy medications during birch pollen season[2].
  • The optimal dosing schedule and amount.
  • Any potential side effects or safety concerns.

One current study is comparing the treatment to a placebo to see how it affects patients’ Combined Symptom and Medication Score (CSMS) during peak birch pollen season[2]. This score helps researchers understand how well the treatment is working to reduce both allergy symptoms and the need for additional medications.

Who is Eligible for Treatment?

While eligibility may vary between different clinical trials, generally, the treatment is being studied in:

  • People aged 12 to 64 years old[2].
  • Those with a confirmed birch pollen allergy, typically diagnosed through skin prick tests and blood tests measuring specific IgE antibodies[2].
  • Individuals who have experienced moderate to severe allergic rhinitis or rhinoconjunctivitis due to birch pollen for at least two previous seasons[2].
  • People who have been treated with anti-allergic medication for at least two birch pollen seasons[2].

Some people may not be eligible for the treatment, including those with severe asthma, certain other medical conditions, or those who have had previous birch pollen immunotherapy within the last 5 years[2].

Potential Side Effects and Precautions

As with any medical treatment, there may be potential side effects. While specific side effects for this treatment are still being studied, common side effects of allergy immunotherapy can include:

  • Local reactions at the injection site (redness, swelling, itching)
  • Mild allergy symptoms (sneezing, runny nose)
  • In rare cases, more severe allergic reactions

The clinical trials have specific safety measures in place, including excluding people with a history of severe allergic reactions or anaphylaxis[2]. Always consult with a healthcare professional about potential risks and benefits before considering any new treatment.

Aspect Details
Study Type Prospective, randomized, double-blind, placebo-controlled multicentre trials
Treatment Betula Pendula Pollen Allergoid, Mannan-Conjugated, Polymerised (T502)
Administration Subcutaneous injection
Target Population Adolescents and adults (12-64 years) with birch pollen-induced allergic rhinitis or rhinoconjunctivitis
Primary Outcome Combined Symptom and Medication Score (CSMS) during peak birch pollen season
Study Duration Approximately 6 months (including screening, treatment, and observation phases)
Key Inclusion Criteria History of moderate to severe allergic symptoms, positive skin prick test, specific IgE to birch pollen
Key Exclusion Criteria Severe asthma, history of anaphylaxis, ongoing immunotherapy, certain medical conditions

FAQ

  • What is the purpose of these clinical trials? The main purpose of these trials is to assess the clinical impact of T502 treatment administered subcutaneously to participants with birch pollen-induced allergic rhinitis or rhinoconjunctivitis. The studies aim to compare symptoms and medication needs between actively treated participants and those receiving a placebo during the peak birch pollen season.
  • Who can participate in these trials? Participants aged 12 to 64 years with a history of moderate to severe allergic rhinitis or rhinoconjunctivitis due to birch pollen for at least two previous seasons can participate. They must have a positive skin prick test to birch pollen allergens and specific IgE against birch pollen allergens. Some trials may have different age ranges, so it's important to check specific eligibility criteria.
  • How is the treatment administered? The treatment, T502 (Betula Pendula Pollen Allergoid, Mannan-Conjugated, Polymerised), is administered subcutaneously. This means it's injected under the skin. The exact dosing schedule and amount may vary between trials, but generally, it's given over a period of several weeks.
  • What is the primary outcome being measured? The primary outcome being measured is the Combined Symptom and Medication Score (CSMS) over the peak birch pollen season. This score compares the symptoms and medication use between the group receiving the active treatment (T502) and the group receiving a placebo.
  • Are there any risks or side effects associated with the treatment? As with any medical treatment, there may be risks and side effects. The trials exclude individuals with a history of severe systemic reactions or anaphylaxis. Participants are closely monitored throughout the study. Specific risks and potential side effects should be discussed with the study doctor before participating in the trial.

Ongoing Clinical Trials on Betula Pendula Pollen Allergoid, Mannan-Conjugated, Polymerised

  • Study on Mannan-Conjugated Birch Pollen Allergoids for Adolescents and Adults with Birch Pollen-Induced Allergic Rhinitis or Rhinoconjunctivitis

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Germany Poland

  • Study on the Effects of Mannan-Conjugated Birch Pollen Allergoids for Adolescents and Adults with Birch Pollen-Induced Allergic Rhinitis or Rhinoconjunctivitis

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Allergic rhinitis: An allergic reaction affecting the nasal passages, causing symptoms such as sneezing, runny nose, and nasal congestion in response to allergens like pollen.
  • Rhinoconjunctivitis: A combination of rhinitis (nasal symptoms) and conjunctivitis (eye symptoms) caused by an allergic reaction, often to airborne substances like pollen.
  • Betula Pendula Pollen Allergoid: A modified form of birch pollen allergen used in immunotherapy, designed to be less allergenic while still promoting immune tolerance.
  • Mannan-Conjugated: A process where the allergoid is linked to mannan, a type of polysaccharide, to enhance its effectiveness in allergy treatment.
  • Polymerised: A chemical process that links multiple allergen molecules together, reducing allergenicity while maintaining immunogenicity.
  • Subcutaneous: Beneath the skin. In these trials, the treatment is injected under the skin.
  • Combined Symptom and Medication Score (CSMS): A measure used to assess the effectiveness of allergy treatments by combining scores for allergy symptoms and medication use.
  • Placebo: An inactive substance that looks like the real treatment but contains no active ingredients, used as a control in clinical trials.
  • Double-blind: A study design where neither the participants nor the researchers directly involved know who is receiving the active treatment and who is receiving the placebo.
  • Specific IgE: Antibodies produced by the immune system in response to specific allergens, used to diagnose allergies.

References

  1. http://clinicaltrials.eu/trial/study-on-mannan-conjugated-birch-pollen-allergoids-for-adolescents-and-adults-with-birch-pollen-induced-allergic-rhinitis-or-rhinoconjunctivitis/
  2. http://clinicaltrials.eu/trial/study-on-the-effects-of-mannan-conjugated-birch-pollen-allergoids-for-adolescents-and-adults-with-birch-pollen-induced-allergic-rhinitis-or-rhinoconjunctivitis/