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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51179

Enrollment

180

Registered

2021-03-24

Start date

2021-04-01

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

Sjögren's syndrome

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

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)

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
The primary endpoint is the antibody based immune response on day 28 after the second vaccination. We will compare SARS-CoV-2 spike (S)- protein specific serum IgG antibody levels (in IU/mL) between patients and controls.	—

Secondary

Measure	Time frame
- Safety (adverse events) reported at day 7 after each vaccination - Corona-related symptoms, COVID-19 infection and -if applicable- SARS-CoV-2 test results during 12 months after vaccination (baseline, day 28, 3, 6, 12 months). - Disease activity (pSS patients only) during 12 months after vaccination (baseline, day 28, 3, 6, 12 months). - Concentrations of anti-SARS-CoV-2 antibodies (IgG en IgA) in saliva at day 28 after the second vaccination (subgroup analysis) - Cellular immune response 7 days after the second vaccination (subgroup analysis)	—

Measure

Time frame

- Safety (adverse events) reported at day 7 after each vaccination - Corona-related symptoms, COVID-19 infection and -if applicable- SARS-CoV-2 test results during 12 months after vaccination (baseline, day 28, 3, 6, 12 months). - Disease activity (pSS patients only) during 12 months after vaccination (baseline, day 28, 3, 6, 12 months). - Concentrations of anti-SARS-CoV-2 antibodies (IgG en IgA) in saliva at day 28 after the second vaccination (subgroup analysis) - Cellular immune response 7 days after the second vaccination (subgroup analysis)

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Countries

Netherlands

Outcome results