BACKGROUND: Cupressaceae pollen allergy is a world-wide pollinosis but immunotherapy has rarely been tested. Immunotherapy is usually allergen-specific but new forms may be targeted towards IgE. OBJECTIVES: A randomized, double-blind, placebo-controlled trial was carried out to assess the efficacy of a vaccine made of keyhole lampet hemocyanin (KLH)-conjugated decapeptide from the Fc(epsilon4) domain of the IgE in cypress pollinosis. METHODS:Sixty patients with cypress pollen allergy were studied. They were included on a suggestive clinical history, positive skin tests and nasal challenge to cypress pollen extract. Three intramuscular injections of the vaccine (250 microg) or placebo were administered monthly with a booster injection 5 to 8 weeks later. The primary end-point criterion was the threshold dose inducing a positive nasal challenge. The secondary end-point was the symptom-medication scores measured when cypress pollen grains were over 50 grains/m3. RESULTS:Nasal challenge before treatment was non-significantly different between the placebo and vaccine groups. After treatment there was no significant difference between the two groups. Pollen counts were over 50 grains/m3 for 8 weeks during the trial. There was no significant difference in total symptom scores between the placebo and vaccine groups. The vaccine was safe. CONCLUSIONS: The KLH-conjugated decapeptide vaccine was not effective in cypress pollen allergy.
RCT Entities:
BACKGROUND: Cupressaceae pollen allergy is a world-wide pollinosis but immunotherapy has rarely been tested. Immunotherapy is usually allergen-specific but new forms may be targeted towards IgE. OBJECTIVES: A randomized, double-blind, placebo-controlled trial was carried out to assess the efficacy of a vaccine made of keyhole lampet hemocyanin (KLH)-conjugated decapeptide from the Fc(epsilon4) domain of the IgE in cypress pollinosis. METHODS: Sixty patients with cypress pollen allergy were studied. They were included on a suggestive clinical history, positive skin tests and nasal challenge to cypress pollen extract. Three intramuscular injections of the vaccine (250 microg) or placebo were administered monthly with a booster injection 5 to 8 weeks later. The primary end-point criterion was the threshold dose inducing a positive nasal challenge. The secondary end-point was the symptom-medication scores measured when cypress pollen grains were over 50 grains/m3. RESULTS: Nasal challenge before treatment was non-significantly different between the placebo and vaccine groups. After treatment there was no significant difference between the two groups. Pollen counts were over 50 grains/m3 for 8 weeks during the trial. There was no significant difference in total symptom scores between the placebo and vaccine groups. The vaccine was safe. CONCLUSIONS: The KLH-conjugated decapeptide vaccine was not effective in cypress pollen allergy.
Authors: T E Twaroch; M Focke; K Fleischmann; N Balic; C Lupinek; K Blatt; R Ferrara; A Mari; C Ebner; P Valent; S Spitzauer; I Swoboda; R Valenta Journal: Clin Exp Allergy Date: 2012-06 Impact factor: 5.018