Completed

NCT Number: NCT04236193

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

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.

Completed

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Key information

Conditions

Shoulder Injury Related to Vaccine Administration Erosion, Localized

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

participation at a local vaccination campaign
Shoulder pain >3 days after vaccination

Exclusion criteria

no vaccine received
preexisting shoulder pathology

Treatment and study plan

Ultrasound Shoulder and Immunological Phenotyping by FACS

Diagnostic Test

Cross-sectional Ultrasound exam of the affected shoulder. Peripheral blood measurements of the T and B cell subsets. Anti-Influenza Antibody measurements

Primary outcomes

Pathological Findings in Ultrasound

Time frame: Ultrasound of the shoulder is performed at Baseline/Inclusion

Cross-sectional assessment and description of pathological ultrasound findings in subjects with shoulder pain after influenza vaccination

Secondary outcomes

Increased Vaccine response

Time frame: Baseline and 12 months

Antibodies against Influenza, Plasmablasts and T follicular helper cell increase

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: SIRVA

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2019
First posted: Jan 22, 2020
Registry last updated: Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.