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

• Register: EUCTR
• Last refreshed on: 26 April 2021
• Main ID: EUCTR2021-001414-10-NL
• Date of registration: 24/03/2021
• Prospective Registration: Yes
• Primary sponsor: University Medical Center Groningen
• Public title: Response to corona vaccination in patients with primary Sjögren's syndrome
• Scientific title: Vaccine response against SARS-CoV-2 in patients with primary Sjögren’s syndrome - VaccineSS
• Date of first enrolment: 30/03/2021
• Target sample size: 180
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-001414-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Netherlands

Contacts

• Name: Postdoctoral researcher
• Affiliation: University Medical Center Groningen

• Name: Postdoctoral researcher
• Affiliation: University Medical Center Groningen

Key inclusion & exclusion 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:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Primary Sjögren's syndrome

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

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 suspension for injection COVID-19 Vaccine (ChAdOx1-S [recombinant])
Pharmaceutical Form: Suspension for injection

Trade Name: COVID-19 Vaccine Janssen suspension for injection COVID-19 vaccine (Ad26.COV2-S [recombinant])
Pharmaceutical Form: Suspension for injection

Primary Outcome(s)

Main Objective: The primary objective is to study protective antibody responses after SARS-CoV-2 vaccination in patients with pSS.

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

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.

Secondary Outcome(s)

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

Secondary ID(s)

202100076

Source(s) of Monetary Support

Dutch Association of Sjögren patients (NVSP)

Ethics review

Status: Approved
Approval date: 30/03/2021
Contact: