Safety and Immune Response Study of Cat-Allergen Intralymphatic Immunotherapy in Adults With Cat Allergy and Asthma

What this Trial Is About

Researchers are evaluating the safety and tolerability of intralymphatic immunotherapy ILIT using ALUTARD SQ Felis domesticus in adults with cat allergy-induced allergic rhinitis and asthma. This study compares ILIT to the traditional subcutaneous immunotherapy SCIT to understand its safety, tolerability, immune response, and effectiveness. The trial is designed to provide data for future studies on treatment efficacy, addressing the need for safer allergy treatments with fewer injections. Participants will receive three to four ILIT injections of ALUTARD SQ Felis domesticus directly into an inguinal lymph node, guided by ultrasound. Doses vary across three groups, with injections spaced at least four weeks apart. The total injection volume ranges from 50 to 200 microliters, with doses from 10 to 10,000 SQ units. This method aims to offer a potentially safer alternative to SCIT, which involves many more injections over a longer period. Throughout the study lasting about eight months, participants will undergo safety monitoring including measurements of blood tryptase and assessments according to World Allergy Organization guidelines. They will complete lung function tests, questionnaires, and a modified nasal provocation test to evaluate asthma and treatment effects. Blood samples will be collected for immunological tests, and quality of life assessments will be conducted. Visits last two to three hours, including pre- and post-injection safety follow-up, to carefully track treatment responses and adverse events.

Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma