AllergyWasPenIPNCT03219827
Pilot Study: Characterization of the Immune Phenotype of Patients Allergic to Wasp Venom or Penicillin
A study testing Human biological samples in people with Allergy, run by Institut Pasteur at 2 sites in France.
Trial summary
Severity of allergic reactions are highly variable from one individual to another, they can range from absent to life threatening. Allergic manifestations and specifically those of anaphylactic reactions are generally attributed to an IgE-dependent activation of mast cells and/or basophils followed by the release of… Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Allergy
- What is being tested?
- Human biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Jun 2017to 31 Dec 2023
- Phase
- Interventional
- 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 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Allergic subjects having done either an allergic reaction at least of grade 3 according to Müller1 or a quincke edema in response to a wasp sting or penicillin intake, otherwise considered as healthy by the investigator based on medical history, clinical examination and laboratory results (blood sampling for laboratory assessments should be done at V0 and only after signed informed consent).
- Subjects who, according to the investigator, can and will comply with the requirements of the protocol and are available for all scheduled visits at the investigational site.
- Wasp or penicillin allergic but otherwise healthy male and female aged between 20 and 69 years.
- 18.5 <= BMI >= 32 kg/m2
- Ability to give their consent in writing
- Must understand spoken and written French
- Affiliated to the French social security or assimilated regimes
Who cannot join
- Subjects who cannot participate according to their status on the registry mentioned at Art L.1121-16 of the French Public Health Code
- Participation in another Clinical study in the last 3 months in which the subject has been exposed to an investigational product (pharmaceutical product or placebo or medical device) or concurrent participation in another clinical study during the study period
- Travel in (sub-)tropical countries within the last 3 months
- For women: pregnant or breastfeeding or intending to become pregnant or peri-menopausal
- Any physical exercise within the last 8 hours before inclusion (V1) and before (V2)
- Presence of evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential patient unable/unlikely to participate in the study satisfactorily.
Show all 14Show fewer
- Severe/chronic/recurrent pathological conditions,
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within the 6 months prior to the V0, V1 or V2. For corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone or equivalent for > 2 weeks (inhaled and topical steroids allowed)
- Chronic administration of NSAIDs, including aspirin: prolonged intake (> 2 weeks) within 6 months before [exception for low dose aspirin: maximum 250mg/daily, see 5.1]
- Receipt of any vaccination 3 months before the inclusion or planning to receive any vaccination during the study
- Receipt of blood products or immunoglobulins within 3 months prior the inclusion or planning to receive blood products or immunoglobulins during the study
- Hemoglobin measurement less than 10.0 g/dL for women and less than 11.5 g/dL for men
- Platelet count less than 120.000/mm3
- ALAT and/or ASAT > 3 times the upper limit of the norm (ULN)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Saint Joseph
Paris, 75015
Service de Pneumologie Hôpital Bichat
Paris, 75018
About this study
Severity of allergic reactions are highly variable from one individual to another, they can range from absent to life threatening. Allergic manifestations and specifically those of anaphylactic reactions are generally attributed to an IgE-dependent activation of mast cells and/or basophils followed by the release of histamine. Recently however evidence accumulated that other pathways might similarly contribute or even trigger anaphylaxis. Moreover, while the variance in human populations is an important subject to scientific research, medical practices and public health policies typically take a 'one for all' approach to disease management and drug development. Indeed, individual heterogeneity in the immune response can have a big impact on the likelihood to respond to therapy. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that define the immune system of allergic patients and its natural occurring variability. Thanks to the efforts that have been made in the framework of the Labex "Milieu Intérieur" study genetic, immunological and environmental factors have been identified that can be linked to the heterogeneity of immune responses in healthy individuals. By comparing these already available data from healthy individuals to a novel cohort of patients with defined severe allergic manifestations, we will be able to identify for the first time immunological and environmental parameters that are common to patients with severe allergies and identify those parameters that distinguish allergic patients from the healthy donor cohort. This analysis will thus open new perspectives on deregulated immune pathways in allergic patients allowing to orient future treatment approaches. Furthermore, comparing immune responses before and after allergen-specific immunotherapy will help understanding, which changes in immune responses are causal to a successful treatment. Importantly, this analysis will shed light on the individual differences that may predict the outcome of treatment approaches and propose novel markers of its success.
Read the detailed description
Severity of allergic reactions are highly variable from one individual to another, they can range from absent to life threatening. Allergic manifestations and specifically those of anaphylactic reactions are generally attributed to an IgE-dependent activation of mast cells and/or basophils followed by the release of histamine. Recently however evidence accumulated that other pathways might similarly contribute or even trigger anaphylaxis. Moreover, while the variance in human populations is an important subject to scientific research, medical practices and public health policies typically take a 'one for all' approach to disease management and drug development. Indeed, individual heterogeneity in the immune response can have a big impact on the likelihood to respond to therapy. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that define the immune system of allergic patients and its natural occurring variability. Thanks to the efforts that have been made in the framework of the Labex "Milieu Intérieur" study genetic, immunological and environmental factors have been identified that can be linked to the heterogeneity of immune responses in healthy individuals. By comparing these already available data to a novel cohort of patients with defined severe allergic manifestations, we will be able to identify for the first time immunological and environmental parameters that are common to patients with severe allergies and identify those parameters that distinguish allergic patients from the healthy donor cohort. This analysis will thus open new perspectives on deregulated immune pathways in allergic patients allowing to orient future treatment approaches. Furthermore, comparing immune responses before and after allergen-specific immunotherapy will help understanding, which changes in immune responses are causal to a successful treatment. Importantly, this analysis will shed light on the individual differences that may predict the outcome of treatment approaches and propose novel markers of its success. Hence, it will give important insights for the individually adapted treatment of patients.
- Conditions
- Allergy
- Being tested
- Human biological samples
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human biological samplesOther
Blood samples collection
| Study group | Role | What they receive |
|---|---|---|
| Patients allergic to wasp venom | Experimental | Patient with major allergic reaction to wasp venom.
* Blood samples collection at visit 1, at visit 2 (4 weeks after visit 1), at visit 3 (one year after treatment onset)
* After visit 1, an allergen-specific immunotherapy will be conducted as part of the classical patient care program. Receives: Other: Human biological samples |
| Patients allergic to penicillin | Experimental | Patient with major allergic reaction to penicillin.
- Blood samples collection at visit 1 and at visit 2 (4 weeks after visit 1= end of study, none treatment will be evaluated in this arm) Receives: Other: Human biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune phenotype of allergic patients
Determination of the immune phenotype of allergic patients through flow cytometric analysis of major blood cell populations
Measured: 3 years
Immune phenotype of allergic patients by determination of cytokine/chemokine levels
Measurement of cytokine/chemokine levels in whole bood following stimulation with 6 immune stimulators.
Measured: 3 years
Secondary outcomes (3)
Differences in immune responses before and after immunotherapy measured by flow cytometric analysis.
Differences between immune responses between patients before and after allergic -specific immunotherapy and between cured and non-cured patients measured by flow cytometric analysis
Measured: 3 years
Differences in immune responses before and after immunotherapy
Differences between immune responses between patients before and after allergic -specific immunotherapy and between cured and non-cured patients measured by cytokine/chemokine levels in whole bood following stimulation with 6 immune stimulators.
Measured: 3 years
Antibody repertoire determination measured by antigen specific ELISA.
Antibody repertoire in wasp venom allergic patients before and after allergen-specific immunotherapy. To determine changes in antigen recognition and subclass composition we will perform antigen specific ELISA.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start13 Jun 2017
- Primary completion29 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alice Seringulian, Principal investigator, Hôpital Saint Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219827
- Sponsor's protocol ID
- 2016-036
- Acronym
- WasPenIP
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2017
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Characterization of the Immune Phenotype of Patients Allergic to Wasp Venom or Penicillin
- ClinicalTrials.gov ID
- NCT03219827
- Acronym / sponsor ID
- WasPenIP / 2016-036
- Conditions
- Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Jul 2017 (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.
Severity of allergic reactions are highly variable from one individual to another, they can range from absent to life threatening. Allergic manifestations and specifically those of anaphylactic reactions are generally attributed to an IgE-dependent activation of mast cells and/or basophils followed by the release of histamine. Recently however evidence accumulated that other pathways might similarly contribute or even trigger anaphylaxis. Moreover, while the variance in human populations is an important subject to scientific research, medical practices and public health policies typically take a 'one for all' approach to disease management and drug development. Indeed, individual heterogeneity in the immune response can have a big impact on the likelihood to respond to therapy. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that define the immune system of allergic patients and its natural occurring variability. Thanks to the efforts that have been made in the framework of the Labex "Milieu Intérieur" study genetic, immunological and environmental factors have been identified that can be linked to the heterogeneity of immune responses in healthy individuals. By comparing these already available data from healthy individuals to a novel cohort of patients with defined severe allergic manifestations, we will be able to identify for the first time immunological and environmental parameters that are common to patients with severe allergies and identify those parameters that distinguish allergic patients from the healthy donor cohort. This analysis will thus open new perspectives on deregulated immune pathways in allergic patients allowing to orient future treatment approaches. Furthermore, comparing immune responses before and after allergen-specific immunotherapy will help understanding, which changes in immune responses are causal to a successful treatment. Importantly, this analysis will shed light on the individual differences that may predict the outcome of treatment approaches and propose novel markers of its success.
Detailed description
Severity of allergic reactions are highly variable from one individual to another, they can range from absent to life threatening. Allergic manifestations and specifically those of anaphylactic reactions are generally attributed to an IgE-dependent activation of mast cells and/or basophils followed by the release of histamine. Recently however evidence accumulated that other pathways might similarly contribute or even trigger anaphylaxis. Moreover, while the variance in human populations is an important subject to scientific research, medical practices and public health policies typically take a 'one for all' approach to disease management and drug development. Indeed, individual heterogeneity in the immune response can have a big impact on the likelihood to respond to therapy. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that define the immune system of allergic patients and its natural occurring variability. Thanks to the efforts that have been made in the framework of the Labex "Milieu Intérieur" study genetic, immunological and environmental factors have been identified that can be linked to the heterogeneity of immune responses in healthy individuals. By comparing these already available data to a novel cohort of patients with defined severe allergic manifestations, we will be able to identify for the first time immunological and environmental parameters that are common to patients with severe allergies and identify those parameters that distinguish allergic patients from the healthy donor cohort. This analysis will thus open new perspectives on deregulated immune pathways in allergic patients allowing to orient future treatment approaches. Furthermore, comparing immune responses before and after allergen-specific immunotherapy will help understanding, which changes in immune responses are causal to a successful treatment. Importantly, this analysis will shed light on the individual differences that may predict the outcome of treatment approaches and propose novel markers of its success. Hence, it will give important insights for the individually adapted treatment of patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients allergic to wasp venom | Experimental | Other: Human biological samplesPatient with major allergic reaction to wasp venom. * Blood samples collection at visit 1, at visit 2 (4 weeks after visit 1), at visit 3 (one year after treatment onset) * After visit 1, an allergen-specific immunotherapy will be conducted as part of the classical patient care program. |
| Patients allergic to penicillin | Experimental | Other: Human biological samplesPatient with major allergic reaction to penicillin. - Blood samples collection at visit 1 and at visit 2 (4 weeks after visit 1= end of study, none treatment will be evaluated in this arm) |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Allergic subjects having done either an allergic reaction at least of grade 3 according to Müller1 or a quincke edema in response to a wasp sting or penicillin intake, otherwise considered as healthy by the investigator based on medical history, clinical examination and laboratory results (blood sampling for laboratory assessments should be done at V0 and only after signed informed consent).
- Subjects who, according to the investigator, can and will comply with the requirements of the protocol and are available for all scheduled visits at the investigational site.
- Wasp or penicillin allergic but otherwise healthy male and female aged between 20 and 69 years.
- 18.5 <= BMI >= 32 kg/m2
- Ability to give their consent in writing
Key exclusion criteria (14 listed)
- Subjects who cannot participate according to their status on the registry mentioned at Art L.1121-16 of the French Public Health Code
- Participation in another Clinical study in the last 3 months in which the subject has been exposed to an investigational product (pharmaceutical product or placebo or medical device) or concurrent participation in another clinical study during the study period
- Travel in (sub-)tropical countries within the last 3 months
- For women: pregnant or breastfeeding or intending to become pregnant or peri-menopausal
- Any physical exercise within the last 8 hours before inclusion (V1) and before (V2)
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 |
|---|---|---|
| Human biological samplesBlood samples collection | Other | Patients allergic to penicillin, Patients allergic to wasp venom |
Primary outcome
Immune phenotype of allergic patients
Time frame: 3 years
Determination of the immune phenotype of allergic patients through flow cytometric analysis of major blood cell populations
Immune phenotype of allergic patients by determination of cytokine/chemokine levels
Time frame: 3 years
Measurement of cytokine/chemokine levels in whole bood following stimulation with 6 immune stimulators.
3 secondary outcomes
Differences in immune responses before and after immunotherapy measured by flow cytometric analysis.
Time frame: 3 years
Differences in immune responses before and after immunotherapy
Time frame: 3 years
Antibody repertoire determination measured by antigen specific ELISA.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Alice Seringulian principal investigator
Hôpital Saint Joseph
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human biological samples in people with Allergy, run by Institut Pasteur at 2 sites in France.
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 7 inclusion and 14 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: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune phenotype of allergic patients (time frame: 3 years). The study lists 2 primary outcomes in all. 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 5 Jun 2024.