Grass Pollen AllergyRTCASNCT01830673
Regulatory T-cells After Subcutaneous Immunotherapy
An observational study of Grass Pollen Allergy and Specific Immunotherapy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The primary endpoint was the induction of T-regulatory cells under s specific subcutaneous immunotherapy (SCIT). Patients suffering from grass pollen allergy (relevant clinical symptomes during the pollen season, Skin Prick test diamter >4mm or RAST class II or higher) were included. Read more about this study
- Who is it for?
- Ages 7 to 28 years
- Conditions the study is for
- Grass Pollen Allergy, Specific Immunotherapy
- Type of treatment
- Vaccines
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Oct 2012
- 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 7 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients aged 7-28 years of age with house grass pollen allergy
Who may be able to join
- informed consent,
- clinically relevant grass pollen allergy,
- age > 6 and < 28
Who cannot join
- severe unstable asthma,
- regular ingestion of antihistamine,
- systemic steroid therapy,
- lung funtcion VC < 70%,
- FEV1 < 65%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of T-regulatory Cells After Subcutaneous Immunotherapy
The primary endpoint was the induction of T-regulatory cells under s specific subcutaneous immunotherapy (SCIT). Patients suffering from grass pollen allergy (relevant clinical symptomes during the pollen season, Skin Prick test diamter >4mm or RAST class II or higher) were included. The patients were allocated to three study groups:
Group 1: during and directly after SCIT (after completion the 2nd or 3rd year of treatment) Group 2: completed SCIT more then three years ago Group 3: Patients with clinically relevant grass pollen allergy without SCIT.
The investigators analyzed the lung function parameters, exhaled NO (eNO) and asked the patients to record symptoms during the adjacent pollen season. A blood sample was drawn to analyze the amount of TH1 and TH2 and regulatory T-cells, inflammatory markers(IL-2, IL-5, IL-10, IL-12/23, TNF-alpha, IFN-gamma) and blocking antibodies (IgG, IgG4).
- Conditions
- Grass Pollen Allergy, Specific Immunotherapy
- Keywords
- T-regulatory cells, TH1, TH2 cells, specific IgE, specific IgG, specific IgG4, IL2, IL5, IL10, IL12/23, Y-IFN, TNF-a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| under SIT | patients completed second or third year of SIT. We include the patients directly after last SIT vaccination. | |
| after SIT | Patients completed three years of SIT for at least three years. We included them as a follow up. | |
| no SIT | These patients were determined randomly. They have a clinically relevant grass pollen allergy. They never had a SIT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction of regulatory t-cells
Determination of T-reulatory cells by FACS (staining for fox p3).
Measured: group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention
Secondary outcomes (4)
TH1-cells by FACS
Staining for CD3, CD4, CD183
Measured: group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention
Th-2 cells by FACS
Staining for CD3, CD4, CD 194
Measured: group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention
Inflammatory cytokines
Cytokines (Il-2, Il-5, Il-10, Il-12/23, IFN-gamma, TNF-alpha) were determined by cytometric bead assay
Measured: group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention
Questionnaire
questionnaire to assess the quality of life (QoL), the clinical symptoms and medication scores during the SCIT adjacent pollen season.
Measured: During the pollen season - for group 1: pollen season directly after completion of SCIT therapy, group 2: same pollen season as group 1, three years after completion of a 3 year SCIT, group 3: same pollen season as group 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startOct 2011
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Grass Pollen AllergyStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospital
- Investigators
- Stefan Zielen, Prof., Study director, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830673
- Sponsor's protocol ID
- FRA-2012-SCIT
- Acronym
- RTCAS
- Status last verified
- Jul 2014
- First submitted
- 20 Nov 2012
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Zielen S, Kardos P, Madonini E. Steroid-sparing effects with allergen-specific immunotherapy in children with asthma: a randomized controlled trial. J Allergy Clin Immunol. 2010 Nov;126(5):942-9. doi: 10.1016/j.jaci.2010.06.002. Epub 2010 Jul 10.
PubMed 20624650Martin M, Michalek SM, Katz J. Role of innate immune factors in the adjuvant activity of monophosphoryl lipid A. Infect Immun. 2003 May;71(5):2498-507. doi: 10.1128/IAI.71.5.2498-2507.2003.
PubMed 12704121Drachenberg KJ, Heinzkill M, Urban E, Woroniecki SR. Efficacy and tolerability of short-term specific immunotherapy with pollen allergoids adjuvanted by monophosphoryl lipid A (MPL) for children and adolescents. Allergol Immunopathol (Madr). 2003 Sep-Oct;31(5):270-7. doi: 10.1016/s0301-0546(03)79195-2.
PubMed 14572416Rosewich M, Schulze J, Eickmeier O, Telles T, Rose MA, Schubert R, Zielen S. Tolerance induction after specific immunotherapy with pollen allergoids adjuvanted by monophosphoryl lipid A in children. Clin Exp Immunol. 2010 Jun;160(3):403-10. doi: 10.1111/j.1365-2249.2010.04106.x. Epub 2010 Mar 16.
PubMed 20345983Rosewich M, Schulze J, Fischer von Weikersthal-Drachenberg KJ, Zielen S. Ultra-short course immunotherapy in children and adolescents during a 3-yrs post-marketing surveillance study. Pediatr Allergy Immunol. 2010 Feb;21(1 Pt 2):e185-9. doi: 10.1111/j.1399-3038.2009.00953.x. Epub 2009 Dec 8.
PubMed 20003062
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of T-regulatory Cells After Subcutaneous Immunotherapy
- ClinicalTrials.gov ID
- NCT01830673
- Acronym / sponsor ID
- RTCAS / FRA-2012-SCIT
- Conditions
- Grass Pollen Allergy, Specific Immunotherapy
- Keywords
- T-regulatory cells, TH1, TH2 cells, specific IgE, specific IgG, specific IgG4, IL2, IL5, IL10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 12 Apr 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 primary endpoint was the induction of T-regulatory cells under s specific subcutaneous immunotherapy (SCIT). Patients suffering from grass pollen allergy (relevant clinical symptomes during the pollen season, Skin Prick test diamter >4mm or RAST class II or higher) were included. The patients were allocated to three study groups:
Group 1: during and directly after SCIT (after completion the 2nd or 3rd year of treatment) Group 2: completed SCIT more then three years ago Group 3: Patients with clinically relevant grass pollen allergy without SCIT.
The investigators analyzed the lung function parameters, exhaled NO (eNO) and asked the patients to record symptoms during the adjacent pollen season. A blood sample was drawn to analyze the amount of TH1 and TH2 and regulatory T-cells, inflammatory markers(IL-2, IL-5, IL-10, IL-12/23, TNF-alpha, IFN-gamma) and blocking antibodies (IgG, IgG4).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| under SIT | – | –patients completed second or third year of SIT. We include the patients directly after last SIT vaccination. |
| after SIT | – | –Patients completed three years of SIT for at least three years. We included them as a follow up. |
| no SIT | – | –These patients were determined randomly. They have a clinically relevant grass pollen allergy. They never had a SIT. |
Who may qualify
- Ages
- 7 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 7-28 years of age with house grass pollen allergy
Key inclusion criteria (3 listed)
- informed consent,
- clinically relevant grass pollen allergy,
- age > 6 and < 28
Key exclusion criteria (5 listed)
- severe unstable asthma,
- regular ingestion of antihistamine,
- systemic steroid therapy,
- lung funtcion VC < 70%,
- FEV1 < 65%
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
Induction of regulatory t-cells
Time frame: group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention
Determination of T-reulatory cells by FACS (staining for fox p3).
4 secondary outcomes
TH1-cells by FACS
Time frame: group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention
Th-2 cells by FACS
Time frame: group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention
Inflammatory cytokines
Time frame: group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention
Questionnaire
Time frame: During the pollen season - for group 1: pollen season directly after completion of SCIT therapy, group 2: same pollen season as group 1, three years after completion of a 3 year SCIT, group 3: same pollen season as group 1 and 2
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 25 Jul 2014.
- Background: PubMed 20624650Zielen S, Kardos P, Madonini E. Steroid-sparing effects with allergen-specific immunotherapy in children with asthma: a randomized controlled trial. J Allergy Clin Immunol. 2010 Nov;126(5):942-9. doi: 10.1016/j.jaci.2010.06.002. Epub 2010 Jul 10.
- Background: PubMed 12704121Martin M, Michalek SM, Katz J. Role of innate immune factors in the adjuvant activity of monophosphoryl lipid A. Infect Immun. 2003 May;71(5):2498-507. doi: 10.1128/IAI.71.5.2498-2507.2003.
- Background: PubMed 14572416Drachenberg KJ, Heinzkill M, Urban E, Woroniecki SR. Efficacy and tolerability of short-term specific immunotherapy with pollen allergoids adjuvanted by monophosphoryl lipid A (MPL) for children and adolescents. Allergol Immunopathol (Madr). 2003 Sep-Oct;31(5):270-7. doi: 10.1016/s0301-0546(03)79195-2.
- Background: PubMed 20345983Rosewich M, Schulze J, Eickmeier O, Telles T, Rose MA, Schubert R, Zielen S. Tolerance induction after specific immunotherapy with pollen allergoids adjuvanted by monophosphoryl lipid A in children. Clin Exp Immunol. 2010 Jun;160(3):403-10. doi: 10.1111/j.1365-2249.2010.04106.x. Epub 2010 Mar 16.
- Background: PubMed 20003062Rosewich M, Schulze J, Fischer von Weikersthal-Drachenberg KJ, Zielen S. Ultra-short course immunotherapy in children and adolescents during a 3-yrs post-marketing surveillance study. Pediatr Allergy Immunol. 2010 Feb;21(1 Pt 2):e185-9. doi: 10.1111/j.1399-3038.2009.00953.x. Epub 2009 Dec 8.
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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.
Stefan Zielen, Prof. study director
Johann Wolfgang Goethe University Hospital
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 Grass Pollen Allergy and Specific Immunotherapy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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: finished, as of the sponsor's last update on 25 Jul 2014. 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 Germany. 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?
Induction of regulatory t-cells (time frame: group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01830673, which also lists 5 linked publications.
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 25 Jul 2014.