Tolerance and immunological changes of chemically modified allergen vaccine of Parietaria judaica in accelerated schedules

Abstract

The physicochemical modification of allergen vaccines provides a chance for administering higher doses in a shorter period of time. We sought to assess the safety and immunological changes of using a biologically standardized and modified Parietaria judaica pollen extract in accelerated schedules. Two accelerated schedules were tested in 45 P. judaica-allergic patients: 20 patients reached the maximum dose after two visits using two different concentrations and 25 patients reached the maximum dose after only one visit with two injections of the maximum concentration vial. The tolerance was assessed by recording all side effects related with immunotherapy. Specific antibody levels against native extract and rPar j 2 allergen were evaluated at the beginning and the end of the study. Allergenic potency determined by enzyme allergosorbent test (EAST) inhibition and skin prick test showed that modified P. judaica pollen had a 99.9% less allergenicity than native extract. After 650 doses administered, two clinically irrelevant local reactions (diameter<0 x 5 cm) and no systemic reactions were registered. Significant increases in allergen-specific IgG4 and IgG against P. judaica extract and rPar j 2 and significant decrease of specific IgE against Par j 2 were observed. The modified extract of P. judaica is safe to treat sensitive patients, even at accelerated regimens, and induces significant immunological changes.

Fig. 1

(a) Coomassie-stained sodium dodecyl page–polyacrylamide gel electrophoresis (SDS-PAGE) of Parietaria judaica native extract (lane 1) and P. judaica polymerized extract (lane 2).

Fig. 2

Specific IgE, IgG, IgG1 and IgG4 levels for whole Parietaria judaica extract (b) and rPar j 2 (b); n.s.: not significant differences. T₀ and T₁ corresponded to samples before and 1 year after specific immunotherapy (SIT).