The study focuses on people who have Allergic rhinitis/rhinoconjunctivitis triggered by exposure to house dust mites. The allergens involved are the tiny insects known as Dermatophagoides pteronyssinus, Dermatophagoides farinae and Blomia tropicalis. The investigational treatment is an injection called Beltavac®, which contains a mixture of these modified allergens, and it will be compared with a placebo injection.
The purpose of the study is to evaluate the effectiveness of the treatment for this type of allergy. Participants will be randomly assigned to receive either the active injection or the placebo, and neither the participants nor the study staff will know which one is given (double‑blind). The injections are given by the subcutaneous route, meaning they are placed just under the skin, and the schedule extends over several months with regular clinic visits.
During the trial, participants will record daily nasal and eye symptoms as well as any allergy medicines taken in a simple diary. Blood samples will be taken at a few visits to measure levels of allergy‑related antibodies such as IgE, which help the body react to allergens. The collected information will be used to determine whether the Beltavac® injection reduces symptoms compared with the placebo.
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