Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorInmunotek S.L.
About this trial
Observational study to evaluate the safety of immunotherapy as a treatment for Hymenoptera venom allergy, analyzing the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting. This study will be conducted in Spain (multicentric) and data will be collected prospectively.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The study population consisted of allergic participants indicated for treatment with immunotherapy with hymenoptera venom (Apis mellifera or Vespula spp.) according to standard clinical practice.
Age equal to or older than 14 years, without gender differences.
Not having received immunotherapy with hymenoptera venom in the previous 5 years.
That they agree to participate in the study and sign the informed consent form. In the case of minors, the parent or guardian of the participant must also sign the informed consent form.
Disqualifiers
Pregnant or breastfeeding women.
Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study.
Participants who do not agree to participate and/or do not sign the informed consent form.
Participants who do not comply with the medical indications or do not show cooperation with respect to the immunotherapy treatment.
Trial population
Participants aged 14 years and older diagnosed with allergy to Apis mellifera and/or Vespula spp. venom, susceptible to receive immunotherapy wit himenoptera venom according to standard clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
VENOX
Biological/VaccineTreatment with allergy vaccine againts Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Patients allergic to hymenoptera venom1 intervention
Trial outcomes
Primary outcomes
1
Incidence of treatment-Emergent adverse reactions (safety and tolerability) in patients diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.) with indication to receive immunotherapy with the causative venom.
Evaluation of the severity of reactions in relation to subcutaneous immunotherapy following the indications proposed by the World Allergy Organization (WAO).
Time frame
12 monthsSecondary outcomes
1
Evaluation of the immunogenicity of the participant after 6 and 12 months of treatment.
Immunological study: total IgE, and specific IgE, IgG4, IgG1 (total extract and molecular components of Vespula spp. and Apis mellifera). The immunological analysis will be performed according to the usual clinical practice of the center and the serum samples will be stored for the complete analysis in the facilities of the sponsor, using the ALEX technique.
Time frame
12 months2
Quality of life in treated participants after 6 and 12 months of treatment.
Questionnaire of "Quality of Life in People Allergic to Hymenoptera Venom" (HiCaVi), property/copyright of SEAIC (Sociedad Española de Alergología e Inmunología Clínica). The quality of life questionnaire consists of 14 questions, the first nine questions are mandatory. The score for each question is inverse to the order of the answer, i.e., the first answer scores 7 and the seventh answer scores 1. The score shall be obtained by adding up all the questions answered and dividing by the total number of questions answered. The total score goes from 1 to 7, being the 1 the worst quality and the 7 the best one.
Time frame
12 months3
Evaluation of the effectiveness of treatment with immunotherapy, once the maintenance dose of 100 μg/mL is reached, in participants suffering spontaneous natural repicures during the 1-year follow-up.
Registration of allergic reactions after spontaneous natural stings.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov