The Russian Federal Medical Biology Agency (FMBA), responsible for the scientific project, announced that clinical trials of the world’s first vaccine against birch pollen allergy and others like it will begin.
Permission to “conduct phase I and II clinical trials of a recombinant vaccine for the prevention of allergy to birch pollen and other foods” was granted to the institution by the Ministry of Health of Russia, as explained.
It was specified that the effectiveness, safety, reactogenicity and immunogenicity of the product will be evaluated in patients who suffer from allergic rhinitis and who have hypersensitivity to birch pollen during the tests. These are expected to start in September and finish next year.
Developed by the FMBA Institute of Immunology in collaboration with the Medical University of Vienna, the hypoallergenic reformulated vaccine aims to combat the effects of allergens similar to birch pollen, including the those present in apples, peaches, peanuts and soybeans.
Current treatments, which require dozens of injections, can last several years and, despite this, they can only reduce the symptoms without eliminating them completely. On the other hand, according to the project’s researchers, the new drug would only need between three and five injections to show effectiveness.
The deputy director of science and innovation at the Institute of Immunology, Igor Shilovsky, confirmed in a quote for Kommersant that traditional treatments are limited to being therapeutic, as their focus is on combating the symptoms without address the underlying cause of the disease.
The FMBA confirmed that, unlike current drugs used in allergen-specific immunotherapy, the product being developed does not contain any native allergens, which ensures its safety. Likewise, this formulation allows its use in the prevention and treatment of allergies.
“The high efficiency and safety of the recombinant allergy vaccine, which has no analogues in the world, has been confirmed by pre-clinical studies,” said the institution. The research made it possible to map the main allergens of birch pollen, which helped to identify the areas responsible for the development of an immune response to that substance, which was included in the drug.
“The frequency of clinical manifestations of birch pollen allergy will be reduced by using the vaccine,” concluded the FMBA. Once the four-stage clinical trials are completed, it is expected that the injection This innovation is available to the public.
2024-08-21 07:20:54
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