AllergyPhase 2NCT02255604
Effect of Intralymphatic Immunotherapy
A Phase 2 study testing Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml. and 0.1 ml Isoton saline in people with Allergy and Immune Tolerance, run by University of Aarhus at 1 site in Denmark.
Trial summary
The investigators want to investigate whether specific immunotherapy can be delivered directly into a lymph node. The investigators think that a direct introduction of allergen to the antigen presenting cells in the lymph node a give a strong immune response and that this can change the number of injections needed in… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Allergy, Immune Tolerance, Injection Site Discomfort
- What is being tested?
- Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml. and 0.1 ml Isoton saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to 1 Feb 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Allergic rhinitis to grass pollen, more than 3 mm reaction at skin prick test for grass, age between 18 and 40 years.
Who cannot join
- Uncontrolled asthma.
- Severe asthma with post bronchodilator test forced expiratory volume at 1 second less than 70% of expected.
- Severe co morbidity. Allergy to Fenol or Aluminium hydroxid.
- Any autoimmune diseases. Treatment with beta blocking medicine.
- Any heart diseases.
- Severe arterial hypertension. Kidney failure.
- Known malignancy. Known pregnancy.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Lungemedicinsk Forskningsafdeling. Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Effect of Intralymphatic Immunotherapy at Basophil Response and Plasmacell Kinetic in Patients With Allergic Rhinitis.
The investigators want to investigate whether specific immunotherapy can be delivered directly into a lymph node. The investigators think that a direct introduction of allergen to the antigen presenting cells in the lymph node a give a strong immune response and that this can change the number of injections needed in allergen immunotherapy. The investigators do measurements of clinical effect and a variety of paraclinical test to see if the investigators can find af biomarker of successful specific immune therapy of grass allergy.
Read the detailed description
Patients are injected with 3 or 4 doses of alk 225 Phleum Pratense 1000 standard quantity units/ml in a lymph node in the groin.
The investigators monitor clinical response and use of medication during the grass pollen season. SMS (Symptom and Medication Score) will be used.
The investigators count the number of immunoglobulin E grass producing plasma cells in blood one week after each injection. The investigators also do basophil activation tests, nasal provocation tests and titrated skin prick test to monitor effect.
Adverse events will be recorded.
- Conditions
- Allergy, Immune Tolerance, Injection Site Discomfort
- Being tested
- Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml., 0.1 ml Isoton saline
- Keywords
- Allergic Rhinitis, Allergen immunotherapy
- Medical subject headings
- Hypersensitivity, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.Drug
4
alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.Drug
3 injection into a lymphnode
0.1 ml Isoton salineDrug
4 injection into a lymphnode
| Study group | Role | What they receive |
|---|---|---|
| intralymphatic immune therapy | Active comparator | Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.
Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. Receives: Drug: Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml. |
| 3 intralymphatic immune therapy | Placebo comparator | Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.
Patients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection. Receives: Drug: alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml. |
| no intralymphatic immune therapy | Sham comparator | Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.
Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control. Receives: Drug: 0.1 ml Isoton saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cSMS (Combined Symptom and Medication Score)
cSMS, Combined symptom and medication score, during grass pollen season in three years follow up.
Minimal score 0, Maximal score 18. Higher score means worse outcome.
Scale:
Itchy/red eys: 0-3, Runny eyes: 0-3, Itchy nose: 0-3, Runny nose: 0-3, Block nose: 0-3, Sneezes: 0-3. Topical antihistamine 1.5 points/1 point. Nasal corticosteroid: 1 point/2 points. Oral antihistamine: 6 points/1 point. Oral prednisolon 1.5 point /3 points.
Elements are summed to a combined score. Different combination methods exists. EAACI recommends means, i.e. symptoms 0-3 plus medicationscore 0-3. This scoringsystem was applied in the last follow-up year.
Measured: 3 years
Secondary outcomes (1)
Change in Circulating Grass Specific Immunoglobulin E Producing Plasmacells
Measured: one week from vaccinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startAug 2013
- Primary completionSep 2015
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Søren Helbo SH Skaarup, MD, Principal investigator, Lungemedicinsk forskningsafdeling. Aarhus University Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255604
- Sponsor's protocol ID
- ILIT
- Status last verified
- Feb 2017
- First submitted
- 17 Sep 2014
- Last updated
- 24 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intralymphatic Immunotherapy at Basophil Response and Plasmacell Kinetic in Patients With Allergic Rhinitis.
- ClinicalTrials.gov ID
- NCT02255604
- Acronym / sponsor ID
- ILIT
- Conditions
- Allergy, Immune Tolerance, Injection Site Discomfort
- Keywords
- Allergic Rhinitis, Allergen immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Posted 18 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want to investigate whether specific immunotherapy can be delivered directly into a lymph node. The investigators think that a direct introduction of allergen to the antigen presenting cells in the lymph node a give a strong immune response and that this can change the number of injections needed in allergen immunotherapy. The investigators do measurements of clinical effect and a variety of paraclinical test to see if the investigators can find af biomarker of successful specific immune therapy of grass allergy.
Detailed description
Patients are injected with 3 or 4 doses of alk 225 Phleum Pratense 1000 standard quantity units/ml in a lymph node in the groin.
The investigators monitor clinical response and use of medication during the grass pollen season. SMS (Symptom and Medication Score) will be used.
The investigators count the number of immunoglobulin E grass producing plasma cells in blood one week after each injection. The investigators also do basophil activation tests, nasal provocation tests and titrated skin prick test to monitor effect.
Adverse events will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intralymphatic immune therapy | Active comparator | Drug: Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml. Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. |
| 3 intralymphatic immune therapy | Placebo comparator | Drug: alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml. Patients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection. |
| no intralymphatic immune therapy | Sham comparator | Drug: 0.1 ml Isoton salineLymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline. Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Allergic rhinitis to grass pollen, more than 3 mm reaction at skin prick test for grass, age between 18 and 40 years.
Key exclusion criteria (7 listed)
- Uncontrolled asthma.
- Severe asthma with post bronchodilator test forced expiratory volume at 1 second less than 70% of expected.
- Severe co morbidity. Allergy to Fenol or Aluminium hydroxid.
- Any autoimmune diseases. Treatment with beta blocking medicine.
- Any heart diseases.
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 |
|---|---|---|
| Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.4 | Drug | intralymphatic immune therapy |
| alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.3 injection into a lymphnode | Drug | 3 intralymphatic immune therapy |
| 0.1 ml Isoton saline4 injection into a lymphnode | Drug | no intralymphatic immune therapy |
Primary outcome
Change in cSMS (Combined Symptom and Medication Score)
Time frame: 3 years
cSMS, Combined symptom and medication score, during grass pollen season in three years follow up. Minimal score 0, Maximal score 18. Higher score means worse outcome. Scale: Itchy/red eys: 0-3, Runny eyes: 0-3, Itchy nose: 0-3, Runny nose: 0-3, Block nose: 0-3, Sneezes: 0-3. Topical antihistamine 1.5 points/1 point. Nasal corticosteroid: 1 point/2 points. Oral antihistamine: 6 points/1 point. Oral prednisolon 1.5 point /3 points. Elements are summed to a combined score. Different combination methods exists. EAACI recommends means, i.e. symptoms 0-3 plus medicationscore 0-3. This scoringsystem was applied in the last follow-up year.
1 secondary outcome
Change in Circulating Grass Specific Immunoglobulin E Producing Plasmacells
Time frame: one week from vaccinations
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Søren Helbo SH Skaarup, MD principal investigator
Lungemedicinsk forskningsafdeling. Aarhus University Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml. and 0.1 ml Isoton saline in people with Allergy and Immune Tolerance, run by University of Aarhus at 1 site in Denmark.
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 1 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: finished, as of the sponsor's last update on 24 May 2021. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in cSMS (Combined Symptom and Medication Score) (time frame: 3 years). 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 24 May 2021.