Response to corona vaccination in patients with primary Sjögren's syndrome

Phase 1

• Conditions: Primary Sjögren's syndrome; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-001414-10-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-24
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Age 18-75 years
Written informed consent
Fulfilment of 2016 ACR-EULAR criteria (for pSS patients)
Female sex (for healthy volunteers)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

Confirmed SARS-CoV-2 infection (current or previous)
Women who are pregnant (self-reported, participants will be asked -when in doubt- to perform a pregnancy test before study entry)
Current use of prednisone >10mg/day, conventional DMARDs (except hydroxychloroquine) or biological DMARDS. Previous use of DMARDs =6 months before inclusion (=12 months for rituximab) is allowed.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to study protective antibody responses after SARS-CoV-2 vaccination in patients with pSS. ;Secondary Objective: Secondary objectives are monitoring of adverse events and disease activity after vaccination, studying the presence of anti- SARS-CoV-2 antibodies (IgA) in saliva (to assess mucosal immunity against the virus) and in-depth analysis of the adaptive immune response to SARS-CoV-2 vaccination in pSS patients, compared to healthy individuals. ;Primary end point(s): The absolute difference in protective antibody titers against SARS-CoV-2 on day 28 after the second vaccination between patients with pSS and healthy controls. ;Timepoint(s) of evaluation of this end point: d28 after second vaccination