GranulomaNCT06130462
Detection of Aluminium-reactive T-lymphocytes in Patients With Vaccination Granulomas
A study testing Aluminum and Tetanus toxoid in people with Granuloma and Aluminum Allergy, run by National Allergy Research Center, Denmark at 1 site in Denmark.
Trial summary
Vaccines and subcutanoeus immunotherapy vaccines often contains aluminium, and may induce itching granulomas at the injection site. This is usually diagnosed by patch testing. Another way of detecting metal allergy is by investigation metal-specific cells in the blood. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Granuloma, Aluminum Allergy
- What is being tested?
- Aluminum and Tetanus toxoid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Sep 2022to 20 Feb 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indivicuals with vaccination granulomas
- controls without granulomas and no suspected contact allergies
Who cannot join
- pregnancy, breastfeeding, recent vaccination, skin diseases
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National Allergy Research Centre, Gentofte Hospital
Hellerup, 2900
About this study
Vaccines and subcutanoeus immunotherapy vaccines often contains aluminium, and may induce itching granulomas at the injection site. This is usually diagnosed by patch testing. Another way of detecting metal allergy is by investigation metal-specific cells in the blood.
We include participants both with and without granulomas, all have a blood test taken where we investigate if any participants have aluminium-specific cirkulation cells, and whether we can detect a difference between participants with and without granulomas.
Read the detailed description
Aluminium-adsorbed vaccines and subcutaneous immunotherapy may induce vaccination granulomas at injection site. Most children have concormitant aluminium contact allergy diagnosed by path testing, but in adults the allergy can rarely be detected by patch tests.
An alternative to patch testing is the blood in vitro lymphocyte proliferation test (LPT), which we investigated using a well-established LPT protocol. This has previously been shown to detect and characterize metal-specific cells and was used to detect circulating aluminium-specific proliferation. The LPT test is based on a single blood sample and has mostly been used to detect drug hypersensitivity. Still, its role in detecting metal allergy is expanding, with recent studies suggesting using the test as a supplement to the patch test when only a few allergens are to be investigated.
- Conditions
- Granuloma, Aluminum Allergy
- Being tested
- Aluminum, Tetanus toxoid
- Keywords
- aluminum, allergy, contact dermatitis, vaccination granuloma, LPT, SCIT
- Medical subject headings
- Granuloma, Hypersensitivity, Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AluminumDiagnostic test
Different concentrations of aluminium added to the blood test in vitro
Tetanus toxoidDiagnostic test
Used as control substance
| Study group | Role | What they receive |
|---|---|---|
| LPT aluminium | Active comparator | Investigation of participants with aluminium allergy versus healthy controls. Aluminium in different concentrations are added to the blood samples to elicit a response Receives: Diagnostic Test: Aluminum |
| LPT control | Placebo comparator | Tetanus toxoid was added to blood samples as control substance. Receives: Diagnostic Test: Tetanus toxoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
LPT
Proliferation of T-cells
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start13 Sep 2022
- Primary completion24 Oct 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GranulomaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Allergy Research Center, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Blom, PhD, Study director, Allergy clinic, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130462
- Sponsor's protocol ID
- H-20073116
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Aluminium-reactive T-lymphocytes in Patients With Vaccination Granulomas
- ClinicalTrials.gov ID
- NCT06130462
- Acronym / sponsor ID
- H-20073116
- Conditions
- Granuloma, Aluminum Allergy
- Keywords
- aluminum, allergy, contact dermatitis, vaccination granuloma, LPT, SCIT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Allergy Research Center, DenmarkUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 14 Nov 2023 (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.
Vaccines and subcutanoeus immunotherapy vaccines often contains aluminium, and may induce itching granulomas at the injection site. This is usually diagnosed by patch testing. Another way of detecting metal allergy is by investigation metal-specific cells in the blood.
We include participants both with and without granulomas, all have a blood test taken where we investigate if any participants have aluminium-specific cirkulation cells, and whether we can detect a difference between participants with and without granulomas.
Detailed description
Aluminium-adsorbed vaccines and subcutaneous immunotherapy may induce vaccination granulomas at injection site. Most children have concormitant aluminium contact allergy diagnosed by path testing, but in adults the allergy can rarely be detected by patch tests.
An alternative to patch testing is the blood in vitro lymphocyte proliferation test (LPT), which we investigated using a well-established LPT protocol. This has previously been shown to detect and characterize metal-specific cells and was used to detect circulating aluminium-specific proliferation. The LPT test is based on a single blood sample and has mostly been used to detect drug hypersensitivity. Still, its role in detecting metal allergy is expanding, with recent studies suggesting using the test as a supplement to the patch test when only a few allergens are to be investigated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPT aluminium | Active comparator | Diagnostic Test: AluminumInvestigation of participants with aluminium allergy versus healthy controls. Aluminium in different concentrations are added to the blood samples to elicit a response |
| LPT control | Placebo comparator | Diagnostic Test: Tetanus toxoidTetanus toxoid was added to blood samples as control substance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indivicuals with vaccination granulomas
- controls without granulomas and no suspected contact allergies
Key exclusion criteria (1 listed)
- pregnancy, breastfeeding, recent vaccination, skin 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 |
|---|---|---|
| AluminumDifferent concentrations of aluminium added to the blood test in vitro | Diagnostic test | LPT aluminium |
| Tetanus toxoidUsed as control substance | Diagnostic test | LPT control |
Primary outcome
LPT
Time frame: 7 days
Proliferation of T-cells
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 14 Nov 2023.
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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.
Lars Blom, PhD study director
Allergy clinic, Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aluminum and Tetanus toxoid in people with Granuloma and Aluminum Allergy, run by National Allergy Research Center, Denmark 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 2 inclusion and 1 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 14 Nov 2023. 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.
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?
LPT (time frame: 7 days). 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 14 Nov 2023.