Could different settings of immunodysfunction have an impact on COVID-19 disease burden, case fatality ratio and immune response following COVID-19 disease or vaccination?

Seroepidemiological survey and study of cellular immunity against SARS-CoV2 in immunocompromised patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12126664

Enrollment

252

Registered

2021-10-11

Start date

2021-10-13

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Influence of different settings of immune dysfunction in immunosuppressed patients on antibody and cellular immune responses following SARS-CoV2 infection and/or COVID-19 vaccination. Infections and Infestations Effects of COVID-19 (SARS-CoV-2 infection) or COVID-19 vaccination in immunocompromised patients

Interventions

Vaccines will be administered according to the Portuguese national vaccination plan against COVID-19, the investigation team won’t be responsible for decision-making regarding vaccine type and brand,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients with HIV infection 2. Adult patients with immune-mediated inflammatory disease on immunosuppressive therapies

Exclusion criteria

Exclusion criteria: 1. Refusal to give informed consent 2. Contraindication to venipuncture

Design outcomes

Primary

Measure	Time frame
Determination of antibodies to the SARS-CoV-2 nucleoprotein (N) and spike (S) protein receptor binding domain SARS-CoV2 will be by electrochemiluminescence using Elecsys-N and Elecsys-S (Roche Diagnostics) and these results will be expressed in U/mL, using blood samples collected on admission and at various times over a 12 - 18 month period, depending on the date of SARS-CoV2 infection and/or administration of the vaccine(s) against COVID-19	—

Measure

Time frame

Determination of antibodies to the SARS-CoV-2 nucleoprotein (N) and spike (S) protein receptor binding domain SARS-CoV2 will be by electrochemiluminescence using Elecsys-N and Elecsys-S (Roche Diagnostics) and these results will be expressed in U/mL, using blood samples collected on admission and at various times over a 12 - 18 month period, depending on the date of SARS-CoV2 infection and/or administration of the vaccine(s) against COVID-19

—

Secondary

Measure	Time frame
Using blood samples collected on admission and at various times over a 12 - 18 month period, depending on the date of SARS-CoV2 infection and/or administration of the vaccine(s) against COVID-19: 1. Measurement of SARS-CoV2 specific reactive CD8+ T cell response using spheromers (Mallajosyula V, et al. 2021) 2. Assessment of SARS-CoV-2 specific memory B cells responses through a flow cytometric assay using a combination of fluorescently labeled antigens as probes to track the induction of virus-specific memory B cells in longitudinal peripheral blood mononuclear cell (PBMC) samples (Goel RR, et al. 2021)	—

Measure

Time frame

Using blood samples collected on admission and at various times over a 12 - 18 month period, depending on the date of SARS-CoV2 infection and/or administration of the vaccine(s) against COVID-19: 1. Measurement of SARS-CoV2 specific reactive CD8+ T cell response using spheromers (Mallajosyula V, et al. 2021) 2. Assessment of SARS-CoV-2 specific memory B cells responses through a flow cytometric assay using a combination of fluorescently labeled antigens as probes to track the induction of virus-specific memory B cells in longitudinal peripheral blood mononuclear cell (PBMC) samples (Goel RR, et al. 2021)

—

Countries

Portugal

Contacts

Public ContactDiana Póvoas

diana.silva@chlc.min-saude.pt+351 217924280

Outcome results

None listed

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