Allergy DesensitizationNCT01914029
Immunological Mechanisms of Allergy Immunotherapy
An observational study of Allergy Desensitization, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The purpose of the study is to add to the knowledge of mechanisms of immune health. Parameters of the immune system will be followed over time in volunteers allergic to dust mites and bee sting after receiving immunization therapy. This information will be compared to healthy volunteers without allergy. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Allergy Desensitization
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2013to Jul 2016
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: 10 volunteers will be enrolled in each group. The study will include seven treatment groups and one control, total number of participants is 80
Who may be able to join
- Diagnosis of allergic rhinitis and evidence of specific immunoglobulin E antibodies to house dust mite.
- Or A history of a bee sting event that resulted in a systemic allergic reaction with evidence of bee venom-specific immunoglobulin E by skin testing 18-45 years, inclusive at time of initial enrollment General good health and ambulatory at time of enrollment Willing and able to sign Informed Consent Available for follow-up for the planned duration of the study Acceptable medical history by screening evaluation and brief clinical assessment
- -
Who cannot join
- Allergy to multiple allergens Active systemic or serious concurrent illness, including febrile illness on the day of blood withdrawal History of immunodeficiency Known or suspected impairment of immunologic function, including, but not limited to clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, blood pressure >150/95 at screening, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- Chronic Hepatitis B or C. Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays are permissible).
- Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
- Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin, Plavix, Aggrenox. May be acceptable after review by investigator.
- Receipt of blood or blood products within the past 6 months Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol History of Guillain-Barré Syndrome
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Immunology Clinic Rambam Medical Center
Haifa, 31096
Eduardo Shahar, Dr., ed_shahar@rambam.health.gov.il
About this study
The purpose of the study is to add to the knowledge of mechanisms of immune health. Parameters of the immune system will be followed over time in volunteers allergic to dust mites and bee sting after receiving immunization therapy. This information will be compared to healthy volunteers without allergy. We aim to bring new understanding of immune processes by this comparison.
Read the detailed description
The process of immunization as a treatment for allergic disease brings about changes that are not all well understood and the understanding about them is developing constantly. In our study we plan to check a large number of immunological parameters to broaden the scope of knowledge of evaluating individuals for immune health across multiple sub fields of medicine and for advancing a basic understanding of immune cell signaling.
The study will involve 70 participants between ages 18-45 of both sexes. Persons enrolled to the study will have been diagnosed with allergic rhinitis caused by dust mite or persons who developed a systemic reaction following bee sting who are candidates to be treated by immunization.
After verification of diagnosis of allergic condition and decision to start immunizations, blood samples will be drawn from participants before immunization weekly for 24 weeks. Blood samples will be analyzed in order to identify immune cell subset differences that change in response to allergy immunotherapy. Comparisons will be made of baseline and stimulation-induced status of protein phosphorylation individuals over the time-series course in which they receive allergy immunotherapy to pinpoint molecular mechanisms underlying desensitization. Evaluations will be made of cellular mechanisms of allergy immunotherapy by comparing over time and between groups, through serum cytokine profiling and blood gene expression of individuals undergoing allergy immunotherapy shots.
- Conditions
- Allergy Desensitization
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological changes within allergic desensitization treatment
- Phenotype changes in time of immune cell subsets count, and relative abundance.
- Compare the baseline and stimulation-induced status of protein phosphorylation individuals over the time-series course in which they receive allergy immunotherapy and pinpoint molecular mechanisms underlying desensitization.
- Evaluate cellular mechanisms of allergy immunotherapy by comparing over time and between groups, through serum cytokine profiling and blood gene expression of individuals undergoing allergy immunotherapy shots.
Measured: 1. Immunological changes from baseline to 4 months
Secondary outcomes (1)
Allergen Immunotherapy
Compare the baseline and stimulation-induced status of protein phosphorylation individuals over the time-series course in which they receive allergy immunotherapy and pinpoint molecular mechanisms underlying desensitization.
Measured: participants will be followed weekly for 4 months and once a month afterwards for a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy DesensitizationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Shahar, Dr., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914029
- Sponsor's protocol ID
- 0032-13-RMB CTIL
- Status last verified
- Aug 2013
- First submitted
- 6 Jun 2013
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Mechanisms of Allergy Immunotherapy
- ClinicalTrials.gov ID
- NCT01914029
- Acronym / sponsor ID
- 0032-13-RMB CTIL
- Conditions
- Allergy Desensitization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 1 Aug 2013 (estimated)
- 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.
The purpose of the study is to add to the knowledge of mechanisms of immune health. Parameters of the immune system will be followed over time in volunteers allergic to dust mites and bee sting after receiving immunization therapy. This information will be compared to healthy volunteers without allergy. We aim to bring new understanding of immune processes by this comparison.
Detailed description
The process of immunization as a treatment for allergic disease brings about changes that are not all well understood and the understanding about them is developing constantly. In our study we plan to check a large number of immunological parameters to broaden the scope of knowledge of evaluating individuals for immune health across multiple sub fields of medicine and for advancing a basic understanding of immune cell signaling.
The study will involve 70 participants between ages 18-45 of both sexes. Persons enrolled to the study will have been diagnosed with allergic rhinitis caused by dust mite or persons who developed a systemic reaction following bee sting who are candidates to be treated by immunization.
After verification of diagnosis of allergic condition and decision to start immunizations, blood samples will be drawn from participants before immunization weekly for 24 weeks. Blood samples will be analyzed in order to identify immune cell subset differences that change in response to allergy immunotherapy. Comparisons will be made of baseline and stimulation-induced status of protein phosphorylation individuals over the time-series course in which they receive allergy immunotherapy to pinpoint molecular mechanisms underlying desensitization. Evaluations will be made of cellular mechanisms of allergy immunotherapy by comparing over time and between groups, through serum cytokine profiling and blood gene expression of individuals undergoing allergy immunotherapy shots.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 10 volunteers will be enrolled in each group. The study will include seven treatment groups and one control, total number of participants is 80
Key inclusion criteria (3 listed)
- Diagnosis of allergic rhinitis and evidence of specific immunoglobulin E antibodies to house dust mite.
- Or A history of a bee sting event that resulted in a systemic allergic reaction with evidence of bee venom-specific immunoglobulin E by skin testing 18-45 years, inclusive at time of initial enrollment General good health and ambulatory at time of enrollment Willing and able to sign Informed Consent Available for follow-up for the planned duration of the study Acceptable medical history by screening evaluation and brief clinical assessment
- -
Key exclusion criteria (7 listed)
- Allergy to multiple allergens Active systemic or serious concurrent illness, including febrile illness on the day of blood withdrawal History of immunodeficiency Known or suspected impairment of immunologic function, including, but not limited to clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, blood pressure >150/95 at screening, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- Chronic Hepatitis B or C. Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays are permissible).
- Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
- Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin, Plavix, Aggrenox. May be acceptable after review by investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immunological changes within allergic desensitization treatment
Time frame: 1. Immunological changes from baseline to 4 months
1. Phenotype changes in time of immune cell subsets count, and relative abundance. 2. Compare the baseline and stimulation-induced status of protein phosphorylation individuals over the time-series course in which they receive allergy immunotherapy and pinpoint molecular mechanisms underlying desensitization. 3. Evaluate cellular mechanisms of allergy immunotherapy by comparing over time and between groups, through serum cytokine profiling and blood gene expression of individuals undergoing allergy immunotherapy shots.
1 secondary outcome
Allergen Immunotherapy
Time frame: participants will be followed weekly for 4 months and once a month afterwards for a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
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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.
Eduardo Shahar, Dr. principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy Desensitization, run by Rambam Health Care Campus at 1 site in Israel.
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 7 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 27 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 Eduardo Shahar, Dr. (972-4-8543580, ed_shahar@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological changes within allergic desensitization treatment (time frame: 1. Immunological changes from baseline to 4 months). 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 27 Aug 2013.