Efficacy and safety of an shortened outpatient vaccination scheme for therapy with insect poison

Efficacy and safety of an accelerated outpatient protocol for hymenoptera venom immunotherapy - ESAP

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002769-44-AT

Enrollment

152

Registered

2015-09-04

Start date

2015-09-28

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunotherapy against systemic anaphylactic sting reactions MedDRA version: 21.1 Level: PT Classification code 10001749 Term: Allergy to sting System Organ Class: 10021428 - Immune system disorders

Interventions

Trade Name: ALUTARD SQ® Insekten Product Name: Alutard SQ® 802 Vespula spp. Pharmaceutical Form: Solution for injection INN or Proposed INN: VESPULA SPP Other descriptive name: VESPULA SPP. (802) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Legally competent male and female subjects with a history of systemic anaphylactic sting reaction (= grade I according to the classification of Ring and Messmer) Age =18 and =70 years Written consent of the participant after being informed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32

Exclusion criteria

Exclusion criteria: Simultaneous participation in another clinical trial Nursing women Absolute contraindication(s) for VIT: - Uncontrolled Asthma - Autoimmune disorders in active forms (nonresponding to treatment) - Pregnancy - AIDS · Pretreatment with Omalizumab

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to develop a short outpatient protocol for the initial phase of hymenoptera venom immunotherapy and to evaluate the efficacy and safety of this accelerated protocol;Secondary Objective: To evaluate efficacy of immunotherapy by sting challenges immediately after reaching the maintenance dose. · To evaluate the frequency of side-effects within the first year of immunotherapy (maintenance phase). · To compare the frequency of side-effects with previously published protocols. · To evaluate whether antihypertensive treatment with beta-blockers and/or ACE inhibitors is associated with a higher frequency and more severe side-effects during VIT. · To evaluate whether the prevalence of cardiovascular diseases and/or pulmonary diseases is associated with a higher frequency and more severe side-effects during VIT. · To evaluate whether high sIgE levels are associated with a higher frequency of sideeffects. · To evaluate whether high tryptase levels are associated with a higher frequency of sideeffects;Primary end point(s): The primary endpoint for the study is the presence of systemic anaphylactic reactions (grade I-IV) during the initial phase of hymenoptera venom immunotherapy. For the primary analysis the proportion of systemic anaphylactic reactions in the study group will be evaluated for bee and wasp venom separately using a one-sided exact 97.5% confidence interval.;Timepoint(s) of evaluation of this end point: 1 year after starting the immunotherapy	—

Measure

Time frame

Main Objective: The primary objective of this study is to develop a short outpatient protocol for the initial phase of hymenoptera venom immunotherapy and to evaluate the efficacy and safety of this accelerated protocol;Secondary Objective: To evaluate efficacy of immunotherapy by sting challenges immediately after reaching the maintenance dose. · To evaluate the frequency of side-effects within the first year of immunotherapy (maintenance phase). · To compare the frequency of side-effects with previously published protocols. · To evaluate whether antihypertensive treatment with beta-blockers and/or ACE inhibitors is associated with a higher frequency and more severe side-effects during VIT. · To evaluate whether the prevalence of cardiovascular diseases and/or pulmonary diseases is associated with a higher frequency and more severe side-effects during VIT. · To evaluate whether high sIgE levels are associated with a higher frequency of sideeffects. · To evaluate whether high tryptase levels are associated with a higher frequency of sideeffects;Primary end point(s): The primary endpoint for the study is the presence of systemic anaphylactic reactions (grade I-IV) during the initial phase of hymenoptera venom immunotherapy. For the primary analysis the proportion of systemic anaphylactic reactions in the study group will be evaluated for bee and wasp venom separately using a one-sided exact 97.5% confidence interval.;Timepoint(s) of evaluation of this end point: 1 year after starting the immunotherapy

—

Secondary

Measure	Time frame
Secondary end point(s): The main secondary endpoint is the outcome of sting challenges after the inital phase to check efficacy of immunotherapy. Secondary endpoints will be analysed using the binomial test for categorical variables and the t-test or the Wilcoxon rank sum tests for continuous variables.;Timepoint(s) of evaluation of this end point: 1 year after starting the immunotherapy	—

Countries

Austria

Contacts

Public ContactDepartment of Dermatology

Medical University of Graz

gunter.sturm@medunigraz.at+436505142129

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026