Ultrasound and Immunological Findings in Patients With Shoulder Injury Related to Vaccine Administration (SIRVA)

Erosion, Localized Clinical Trial

— SIRVA  

Official title:

Ultrasound and Immunological Findings in Patients With Shoulder Injury Related to Vaccine Administration (SIRVA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04236193
• Other study ID #: SIRVA
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Accidental vaccine injection into adjunct shoulder structures can cause tissue damage, termed Shoulder injury related to vaccine administration (SIRVA). The immunopathological mechanisms and consequences of SIRVA are unknown.

The study assesses the clinical and immunological consequences of an influenza vaccine if accidentally administered in periarticular space.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• participation at a local vaccination campaign

• Shoulder pain >3 days after vaccination

Exclusion Criteria:

• no vaccine received

• preexisting shoulder pathology

Related Conditions & MeSH terms

• Erosion, Localized
• Shoulder Injuries
• Shoulder Injury Related to Vaccine Administration
• Wounds and Injuries

Intervention

Diagnostic Test:
• Ultrasound Shoulder and Immunological Phenotyping by FACS
Cross-sectional Ultrasound exam of the affected shoulder. Peripheral blood measurements of the T and B cell subsets. Anti-Influenza Antibody measurements

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Findings in Ultrasound	Cross-sectional assessment and description of pathological ultrasound findings in subjects with shoulder pain after influenza vaccination	Ultrasound of the shoulder is performed at Baseline/Inclusion
Secondary	Increased Vaccine response	Antibodies against Influenza, Plasmablasts and T follicular helper cell increase	Baseline and 12 months