Allergy to Himenoptera VenomHIPNOSNCT04112797
Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom
An observational study of Allergy to Himenoptera Venom, run by Roxall Medicina España S.A at 8 sites in Spain.
Trial summary
It is a safety and tolerability study of Allergovac Himenopteros in patients sensitized to Apis mellifera, Polistes Dominula or Vespula spp. To get this aim all adverse reactions will be recorded through the study. In addition, it will be evaluated the treatment efficacy with the re-sting after a year of treatment. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Allergy to Himenoptera Venom
- What is being tested?
- Allergovac himenoptera
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 8 sitesSpain
- Study dates
- 23 May 2019to Nov 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with allergy to himenoptera venom.
Who may be able to join
- 1. Patients over 14 years of age with allergy to bee venom, Polistes or Vespula. To meet this criteria, patients must present a systemic reaction with the bite of one of these insects, plus specific IgE detection in the skin test and / or IgE against the himenoptera venom.
- 2. Prescription treatment with Hymenoptera venom must be indicated and patients are susceptible to receive Allergovac® Hymenoptera, according to usual clinical practice.
- 3. Patients who have given their written consent. In the case of minors, the assent will always be signed by the parent / legal guardian, in addition to the minor.
Who cannot join
- Patients who have received treatment with Allergovac® Hymenoptera prior to inclusion in the study.
- Patients under treatment with immunotherapy against aeroallergens.
- Patients who have received previous treatment with immunotherapy, with any of the venoms that they are going to receive, in the 5 years prior to the inclusion in the study.
- Patients who under investigator opinion may present difficulties that prevent the comprehension of what was written in the information sheet for the patient, the informed consent or the completion of self-administered questionnaires.
- Patients who are participating in another clinical trial or observational study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites, 7 recruiting
- Recruiting
C.H.U. A Coruña
A Coruña, 15006
Antonio Parra, Dr., antonio.parra.arrondo@sergas.es
- Recruiting
Hospital Santa Maria
Lleida, 25198
lluis Marqués, MP, lmarques@gss.scs.es
- Recruiting
Hospital Fundación Alcorcón
Madrid, 28922
Teresa Alfaya, Dr., teresa.alfaya@salud.madrid.org
- Not yet recruiting
Hospital Universitario Reina Sofia
Murcia
Antonio Carbonell, Dr., acm50g@gmail.com
- Recruiting
Hospital Vega Baja Orihuela
Orihuela, Alicante, 03314
Angel Ferrer, angelyferrer@gmail.com
- Recruiting
Hospital Joan XXIII
Tarragona, 43005
Gaspar Dalmau, MP, gdalmau.hj23.ics@gencat.cat
- Recruiting
Hospital Universitario La Fe
Valencia, 46026
Dolores Hernández, MP, hernandez_dol@gva.es
- Completed
Hospital Mexoeiro
Vigo, Pontevedra, 36313
About this study
Official title: Prospective Observational Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom
It is a safety and tolerability study of Allergovac Himenopteros in patients sensitized to Apis mellifera, Polistes Dominula or Vespula spp. To get this aim all adverse reactions will be recorded through the study. In addition, it will be evaluated the treatment efficacy with the re-sting after a year of treatment.
- Conditions
- Allergy to Himenoptera Venom
- Being tested
- Allergovac himenoptera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergovac himenopteraBiological
Treatment with allergy vaccine againts Apis mellifera, Vespula spp or Polistes dominula
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by WAO classification
All adverse events ocurred during the study Will be collected and clasified following the WAO recommendations. The percentages Will be exposed by number of patients and by dose administrations.
Measured: During 1 year
Secondary outcomes (1)
Efficacy of vaccine evaluating re-sting test
Grade of treatment protection after controlled sting
Measured: Result of the re-sting test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start23 May 2019
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy to Himenoptera VenomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Roxall Medicina España S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112797
- Sponsor's protocol ID
- ROX-ALE-2018-02
- Acronym
- HIPNOS
- Status last verified
- Mar 2022
- First submitted
- 18 Jun 2019
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom
- ClinicalTrials.gov ID
- NCT04112797
- Acronym / sponsor ID
- HIPNOS / ROX-ALE-2018-02
- Conditions
- Allergy to Himenoptera Venom
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Roxall Medicina España S.AIndustry (pharma, biotech, devices)
- Study start
- 23 May 2019 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a safety and tolerability study of Allergovac Himenopteros in patients sensitized to Apis mellifera, Polistes Dominula or Vespula spp. To get this aim all adverse reactions will be recorded through the study. In addition, it will be evaluated the treatment efficacy with the re-sting after a year of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with allergy to himenoptera venom.
Key inclusion criteria (3 listed)
- 1. Patients over 14 years of age with allergy to bee venom, Polistes or Vespula. To meet this criteria, patients must present a systemic reaction with the bite of one of these insects, plus specific IgE detection in the skin test and / or IgE against the himenoptera venom.
- 2. Prescription treatment with Hymenoptera venom must be indicated and patients are susceptible to receive Allergovac® Hymenoptera, according to usual clinical practice.
- 3. Patients who have given their written consent. In the case of minors, the assent will always be signed by the parent / legal guardian, in addition to the minor.
Key exclusion criteria (5 listed)
- Patients who have received treatment with Allergovac® Hymenoptera prior to inclusion in the study.
- Patients under treatment with immunotherapy against aeroallergens.
- Patients who have received previous treatment with immunotherapy, with any of the venoms that they are going to receive, in the 5 years prior to the inclusion in the study.
- Patients who under investigator opinion may present difficulties that prevent the comprehension of what was written in the information sheet for the patient, the informed consent or the completion of self-administered questionnaires.
- Patients who are participating in another clinical trial or observational study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allergovac himenopteraTreatment with allergy vaccine againts Apis mellifera, Vespula spp or Polistes dominula | Biological | – |
Primary outcome
Number of participants with treatment-related adverse events as assessed by WAO classification
Time frame: During 1 year
All adverse events ocurred during the study Will be collected and clasified following the WAO recommendations. The percentages Will be exposed by number of patients and by dose administrations.
1 secondary outcome
Efficacy of vaccine evaluating re-sting test
Time frame: Result of the re-sting test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy to Himenoptera Venom, run by Roxall Medicina España S.A at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Cruz Gómez, MP (+34 944438000, maricruz.gomez@roxall.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by WAO classification (time frame: During 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.