Immunity against SARS-CoV-2 in immune-suppressed patients: increased risk of insufficient immunological memory or sufficient protection against re-infection? A Target to B! substudy

Immunity against SARS-CoV-2 in immune-suppressed patients: increased risk of insufficient immunological memory or sufficient protection against re-infection? A Target to B! substudy - T2B! immunity after SARS-CoV-2

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55289

Enrollment

5350

Registered

2020-09-01

Start date

2020-10-21

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

hematologische en andere B-cel gemedieerde aandoeningen immunity immunosuppressive medication SARS-CoV-2 infection

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: fase 1: auto-immune disease, treatment with at least one immunosuppressive medication, SARS-CoV-2 infection fase 2/group 1:auto-immune disease fase 2/group 2: healthy control

Exclusion criteria

Exclusion criteria: Known pregnancy during study entry. Concomitant treatment with immunosuppressive medication (like chemotherapy) for cancer or organ-transplantation (including stem-cell transplantation).

Design outcomes

Primary

Measure	Time frame
• Effects of systemic immunosuppressive medication on the serologic response at 28-days after the second SARS-CoV-2 vaccination • Difference in SARS-CoV-2-specific B- and T-cell frequencies and functional phe-notype and determinants thereof	—

Secondary

Measure	Time frame
• Changes in SARS-CoV-2 IgM, IgG and IgA responses over time and determinants thereof • Speed of mounting, the magnitude and persistence of the immune response against SARS-CoV-2 and determinants thereof • Number of confirmed SARS-CoV-2 (re-) infections and determinants thereof. • Change in disease activity and/or relapses of underlying autoimmune disorders • Clinical determinants (including age and gender, disease, disease mechanism and medication) of SIAP • Clinical determinants of patient choices and preferences related to vaccine administrations • Differences in IgG/IgM/IgA antibodies against different SARS-CoV-2 proteins over time • Change in disease activity and/or relapses of underlying autoimmune disorders within 8 weeks after SARS-CoV-2 infection and vaccination • Changes in and determinants of disease activity and/or relapses in the underlying AID during the study period • Incidence and determinations of short-term adverse events after vaccination • Differences in and determinants of severity of SARS-CoV-2 (re-) infections. • The number of ISP with SARS-CoV-2 IgM, IgG and IgA antibodies at baseline in patients with previously positive PCR. • Compare early SIAP development to immunity at follow-up and development of induced immunity after vaccination • Effects of a second booster SARS-CoV-2 vaccine (third vaccine) on serological and cellular responses in immune-suppressed patients • Effects of a second booster SARS-CoV-2 vaccine (third vaccine) on adverse events within 7 days after vaccination, and changes in activity of underlying auto- immune disorders within 8 weeks after vaccination	—

Measure

Time frame

• Changes in SARS-CoV-2 IgM, IgG and IgA responses over time and determinants thereof • Speed of mounting, the magnitude and persistence of the immune response against SARS-CoV-2 and determinants thereof • Number of confirmed SARS-CoV-2 (re-) infections and determinants thereof. • Change in disease activity and/or relapses of underlying autoimmune disorders • Clinical determinants (including age and gender, disease, disease mechanism and medication) of SIAP • Clinical determinants of patient choices and preferences related to vaccine administrations • Differences in IgG/IgM/IgA antibodies against different SARS-CoV-2 proteins over time • Change in disease activity and/or relapses of underlying autoimmune disorders within 8 weeks after SARS-CoV-2 infection and vaccination • Changes in and determinants of disease activity and/or relapses in the underlying AID during the study period • Incidence and determinations of short-term adverse events after vaccination • Differences in and determinants of severity of SARS-CoV-2 (re-) infections. • The number of ISP with SARS-CoV-2 IgM, IgG and IgA antibodies at baseline in patients with previously positive PCR. • Compare early SIAP development to immunity at follow-up and development of induced immunity after vaccination • Effects of a second booster SARS-CoV-2 vaccine (third vaccine) on serological and cellular responses in immune-suppressed patients • Effects of a second booster SARS-CoV-2 vaccine (third vaccine) on adverse events within 7 days after vaccination, and changes in activity of underlying auto- immune disorders within 8 weeks after vaccination

—

Countries

Netherlands

Outcome results