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

Vaccine response against SARS-CoV-2 in patients with primary Sjögren’s syndrome - VaccineSS

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001414-10-NL

Enrollment

180

Registered

2021-03-24

Start date

2021-03-30

Completion date

Unknown

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjögren's syndrome

Interventions

Trade Name: Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Pharmaceutical Form: Dispersion for injection Trade Name: COVID-19 Vaccine AstraZeneca suspe

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): Safety: - Incidence and severity of solicited AEs during 7 days after each vaccination (see Appendix 1) - Incidence and nature of SAEs during 7 days after each vaccination Disease activity: - Change in ESSPRI score between baseline and consecutive time points after the second vaccination - Change in patient global assessment of disease activity between baseline and consecutive time points after the second vaccination (28 days, 3, 6 and 12 months) - Change in ESSDAI (subgroup only). ESSDAI is assessed at regular outpatient clinic visits that take place every 6 to 12 months. In-depth assessment of immune response: - Assessment of SARS-CoV2 specific T cells at d7 after the second vaccination using a high throughput IFN-? ELIspot assay - Absolute number and frequency of Tfh cells and plasmablasts at baseline and d7 - Measurement of SARS-CoV-2 specific antibodies (IgG & IgA) in saliva at baseline and d28 - Assessment of total memory and SARS-CoV2 specific B cells at 3-6 months after the second vaccination ;Timepoint(s) of evaluation of this end point: Safety: d7 after each vaccination Disease activity: d28, 3, 6, 12 months after second vaccination Immune response: d7 of d28 after second vaccination	—

Measure

Time frame

Secondary end point(s): Safety: - Incidence and severity of solicited AEs during 7 days after each vaccination (see Appendix 1) - Incidence and nature of SAEs during 7 days after each vaccination Disease activity: - Change in ESSPRI score between baseline and consecutive time points after the second vaccination - Change in patient global assessment of disease activity between baseline and consecutive time points after the second vaccination (28 days, 3, 6 and 12 months) - Change in ESSDAI (subgroup only). ESSDAI is assessed at regular outpatient clinic visits that take place every 6 to 12 months. In-depth assessment of immune response: - Assessment of SARS-CoV2 specific T cells at d7 after the second vaccination using a high throughput IFN-? ELIspot assay - Absolute number and frequency of Tfh cells and plasmablasts at baseline and d7 - Measurement of SARS-CoV-2 specific antibodies (IgG & IgA) in saliva at baseline and d28 - Assessment of total memory and SARS-CoV2 specific B cells at 3-6 months after the second vaccination ;Timepoint(s) of evaluation of this end point: Safety: d7 after each vaccination Disease activity: d28, 3, 6, 12 months after second vaccination Immune response: d7 of d28 after second vaccination

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Countries

Netherlands

Contacts

Public ContactPostdoctoral researcher

University Medical Center Groningen

g.m.p.j.verstappen@umcg.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026