Background: Four administration schedules of immunotherapy have been reported: conventional, cluster, rush and ultra-rush. Objectives: To evaluate the safety and the clinical advantage of using standardized modified allergen extracts in an ultra-rush protocol without premedication and/or hospitalization. Material and Methods: One thousand and sixty-eight patients with rhinoconjunctivitis and/or asthma sensitized to mites and/or pollen were included in a prospective observational study. Patients received a therapeutic vaccine containing depigmented and glutaraldehyde-modified extracts (mites and/or pollens) adsorbed onto alum prescribed by a specialist. The schedule of administration consisted of injecting 0.2 and 0.3 ml of the vial of maximum concentration during the first day of immunotherapy, separated by a time interval of 30 min. All patients reached the maximum dose (0.5 ml) after 2 injections. Tolerance was assessed by recording all side reactions related to immunotherapy, classified according to the criteria of the EAACI. Results: The total number of injections was 2,136. All patients reached the maximum established dose on the 1st day. No premedication was used. Seven clinically relevant local reactions were recorded. The systemic reactions were 5 grade-1 (2 immediate and 3 delayed) and 3 delayed grade-2 reactions. Conclusions: The therapeutic vaccines containing chemically modified extracts can be administered using an alternative ultra-rush schedule in an immunotherapy unit, reaching the maximum dose on the 1st day with 2 injections, without the need of premedication and/or hospitalization.

Specific immunotherapy using modified allergen vaccines is safe to treat allergic patients. The percentage of adverse reactions detected is lower than those reported in the literature with native-unmodified allergen extracts.

Specific immunotherapy using natural modified allergen vaccines is safe to treat allergic patients, even at higher doses and in mixtures of unrelated allergen extracts. The percentage of adverse reactions detected is lower than those reported in the literature with native unmodified allergen extracts.

Background Polymerized allergens conjugated to non‐oxidized mannan (PM‐allergoids) are novel vaccines targeting dendritic cells (DCs). Previous experimental data indicate that PM‐allergoids are readily taken up by DCs and induce Treg cells. This first‐in‐human study was aimed to evaluate safety and to find the optimal dose of house dust mite PM‐allergoid (PM‐HDM) administered subcutaneously (SC) or sublingually (SL). Methods In a randomized, double‐blind, double‐dummy, placebo‐controlled trial, 196 subjects received placebo or PM‐HDM at 500, 1000, 3000, or 5000 mannan‐conjugated therapeutic units (mTU)/mL in 9‐arm groups for 4 months. All subjects received 5 SC doses (0.5 ml each) every 30 days plus 0.2 ml SL daily. The primary efficacy outcome was the improvement of titrated nasal provocation tests (NPT) with D. pteronyssinus at baseline and at the end of the study. All adverse events and reactions were recorded and assessed. Secondary outcomes were the combination of symptom and medication scores (CSMS) and serological markers. Results No moderate or severe adverse reactions were reported. Subjects improving the NPT after treatment ranged from 45% to 62% in active SC, 44% to 61% in active SL and 16% in placebo groups. Statistical differences between placebo and active groups were all significant above 500 mTU, being the highest with 3000 mTU SL (p = 0.004) and 5000 mTU SC (p = 0.011). CSMS improvement over placebo reached 70% (p < 0.001) in active 3000 mTU SC and 40% (p = 0.015) in 5000 mTU SL groups. Conclusions PM‐HDM immunotherapy was safe and successful in achieving primary and secondary clinical outcomes in SC and SL at either 3000 or 5000 mTU/ml.

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