Results of a clinical trial with a Dermatophagoides pteronyssinus tyrosine adsorbed vaccine.
Twenty-eight patients were included in a double-blind placebo-controlled study of a vaccine containing tyrosine-adsorbed Dermatophagoides pteronyssinus antigen (Migen(R)). The aim of the trial was to show the efficacy and safety of Migen as a 6-injection course, with or without a follow-up course of 6 maintenance doses, for the treatment of bronchial asthma. The patients selected had suffered from perennial asthma for at least 2 years and gave a strong skin reaction to house dust mite. The subjects in the study were divided into two groups: one of twelve patients receiving only a standard course of six graded injections at weekly intervals and the other of sixteen patients receiving the same course followed by a maintenance course comprising six injections of the highest strength (400 N.U.). Approximately half the patients in each of these groups were on placebo. Assessment was based on the patient's and doctor's impression of the response to the treatment using a daily symptom record card and clinical observation of the patient at regular intervals. The overall assessment was graded in accordance with the following four point scale: very good, good, same and worse. Results showed that the pa tients receiving Migen as a 6-injection course responded better than patients receiving placebo; moreover, patients who received 6 maintenance injections of Migen gave a very good or good response compared to those who were submitted to 12 injections of placebo and also compared to those receiving the standard course. Particular notice was taken of the side effects of the vaccine. Migen proved to be a good and and safe method of treating bronchial asthma due to house dust mite (D. pteronyssinus).
D000293:Adolescent; D000328:Adult; D000941:Antigens / Q000008:administration & dosage*; D001688:Biological Products / Q000008:administration & dosage / Q000009:adverse effects; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007167:Immunotherapy; D008297:Male; D008875:Middle Aged; D008925:Mites / Q000276:immunology*; D010919:Placebos; D006255:Rhinitis, Allergic, Seasonal / Q000276:immunology / Q000628:therapy*; D014443:Tyrosine / Q000008:administration & dosage* / Q000009:adverse effects; D014612:Vaccines / Q000008:administration & dosage / Q000009:adverse effects
D000941:Antigens; D001688:Biological Products; D010919:Placebos; D014612:Vaccines; D014443:Tyrosine