NCT06130462

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

November 8, 2023

Last Update Submit

November 8, 2023

Conditions

GranulomaAluminum Allergy

Keywords

aluminumallergycontact dermatitisvaccination granulomaLPTSCIT

Outcome Measures

Primary Outcomes (1)

  • LPT

    Proliferation of T-cells

    7 days

Study Arms (2)

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

Diagnostic Test: Aluminum

LPT control

PLACEBO COMPARATOR

Tetanus toxoid was added to blood samples as control substance.

Diagnostic Test: Tetanus toxoid

Interventions

AluminumDIAGNOSTIC_TEST

Different concentrations of aluminium added to the blood test in vitro

LPT aluminium
Tetanus toxoidDIAGNOSTIC_TEST

Used as control substance

LPT control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indivicuals with vaccination granulomas
  • controls without granulomas and no suspected contact allergies

You may not qualify if:

  • pregnancy, breastfeeding, recent vaccination, skin diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Allergy Research Centre, Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

GranulomaHypersensitivityDermatitis, Contact

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsImmune System DiseasesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Lars Blom, PhD

    Allergy clinic, Gentofte Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 14, 2023

Study Start

September 13, 2022

Primary Completion

October 24, 2022

Study Completion

February 20, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

DK(1)