Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorInmunotek S.L.
About this trial
Observational clinical follow-up to evaluate the safety of immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions. It includes the evaluation of controlled and spontaneous stings. This study will be conducted in Spain (multicentric), 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 hymenoptera venom immunotherapy (Apis mellifera or Vespula spp.) according to standard clinical practice.
Participants of both sexes aged 14 years or more.
Participants who have not received immunotherapy with hymenoptera venom in the previous 5 years.
Participants who have agreed to take part in the study and sign the informed consent form. In the case of minors, the patient's parent or guardian must also sign.
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 medical indications or do not cooperate with immunotherapy treatment.
Trial population
Participants of both gender aged 14 years or more diagnosed of allergy to Apis mellifera and/or Vespula spp. venom, susceptible to receive ITVH according to standard clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
VENOX
Biological/VaccineTreatment with allergy vaccine against Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.
Treatment groups
80 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 participants diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.).
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 effectiveness of treatment with immunotherapy, once the maintenance dose of 100 μg/mL is reached, in participants suffering spontaneous natural stings during the 1-year follow-up.
Registration of allergic reactions, spontaneous natural stings and a controlled sting test in participants sensitised to hymenoptera venom (Apis mellifera and/or Vespula spp.).
Time frame
12 months2
Immunological parameters of the participants after 12 months of treatment.
Immunological study: total IgE, 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 site and the serum samples will be stored for the complete analysis in the facilities of the sponsor, using the ALEX technique.
Time frame
12 months3
SEAIC (Spanish Society of Allergology and Clinical Immunology) Quality of life Questionnaire for people allergic to hymenoptera venom.
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 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, with 1 indicating the worst quality of life and 7 the best.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov