NCT04799808

Brief Summary

To investigate short- (3 and 8 weeks) and long-term (6, 9, 12, and 18 months) immune protection or response at the humoral and cellular levels before and after SARS-CoV-2 infection or vaccination in patients with moderately reduced immune status (dialysis patients) and severely reduced immune status (organ transplant recipients, mostly kidney transplant recipients) and immunocompetent subjects (medical staff) in Saxony, Germany.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

2.5 years

First QC Date

March 8, 2021

Last Update Submit

August 2, 2022

Conditions

SARS-CoV-2 InfectionActive ImmunizationImmune ResponseImmunosuppression

Keywords

SARS-CoV-2Covid-19dialysisimmunosuppressionsolid organ transplantationkidney transplant recipientshumoral immimmune responsecellular immune response

Outcome Measures

Primary Outcomes (30)

  • Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    3 to 4 weeks after vaccination or infection

  • Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    8 weeks after vaccination or infection

  • Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    4 months after vaccination or infection

  • Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    6 months after vaccination or infection

  • Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    9 months after vaccination or infection

  • Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    12 months after vaccination or infection

  • Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    15 months after vaccination or infection

  • Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    18 months after vaccination or infection

  • Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    21 months after vaccination or infection

  • Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    24 months after vaccination or infection

  • Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    3 to 4 weeks after vaccination or infection

  • Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    8 weeks after infection or vaccination

  • Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    4 months after infection or vaccination

  • Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    6 months after infection or vaccination

  • Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    9 months after infection or vaccination

  • Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    12 months after infection or vaccination

  • Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    15 months after infection or vaccination

  • Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    18 months after infection or vaccination

  • Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    21 months after infection or vaccination

  • Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    24 months after infection or vaccination

  • Cellular response to SARS-CoV-2 infection or vaccination

    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

    3 to 4 weeks after infection or vaccination

  • Cellular response to SARS-CoV-2 infection or vaccination

    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

    8 weeks after infection or vaccination

  • Cellular response to SARS-CoV-2 infection or vaccination

    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

    4 months after infection or vaccination

  • Cellular response to SARS-CoV-2 infection or vaccination

    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

    6 months after infection or vaccination

  • Cellular response to SARS-CoV-2 infection or vaccination

    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

    9 months after infection or vaccination

  • Cellular response to SARS-CoV-2 infection or vaccination

    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

    12 months after infection or vaccination

  • Cellular response to SARS-CoV-2 infection or vaccination

    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

    15 months after infection or vaccination

  • Cellular response to SARS-CoV-2 infection or vaccination

    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

    18 months after infection or vaccination

  • Cellular response to SARS-CoV-2 infection or vaccination

    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

    21 months after infection or vaccination

  • Cellular response to SARS-CoV-2 infection or vaccination

    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

    24 months after infection or vaccination

Secondary Outcomes (90)

  • SARS-CoV-2 incidence and prevalence

    3 to 4 weeks after infection or vaccination

  • SARS-CoV-2 incidence and prevalence

    8 weeks after infection or vaccination

  • SARS-CoV-2 incidence and prevalence

    4 months after infection or vaccination

  • SARS-CoV-2 incidence and prevalence

    6 months after infection or vaccination

  • SARS-CoV-2 incidence and prevalence

    9 months after infection or vaccination

  • +85 more secondary outcomes

Study Arms (2)

BioNTech cohort

The BioNTech cohort is composed of 1000 study participants who will be protected from SARS-CoV-2 infection by comirnaty vaccine from BioNTech. The study participants consist of mildly immunocompromised dialysis patients, severely immunocompromised solid organ transplant recipients, and the staff caring for them in the nephrology dispensaries.

Moderna cohort

The Moderna cohort is composed of 1000 study participants who will be protected from SARS-CoV-2 infection by Moderna Biotech vaccine. The study participants consist of mildly immunocompromised dialysis patients, severely immunocompromised kidney transplant recipients, and the staff caring for them in the nephrology dispensaries.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

2000-3000 subjects

You may qualify if:

  • Dialysis patients, organ transplant recipients and medical staff
  • written consent to participate in the study

You may not qualify if:

  • Age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univercity Hospital Carl Gustav Carus

Dresden, Saxony, 01307, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, in particular serum and PBMCs

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Christian Hugo, Prof.

    Univercity Hospital Carl Gustav Carus

    STUDY DIRECTOR

Central Study Contacts

Christian Hugo, Prof.

CONTACT

+49351458 4879Christian.Hugo@uniklinikum-dresden.de

Julian Stumpf, Dr.

CONTACT

+49351458 12165Julian.Stumpf@uniklinikum-dresden.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Christian Hugo

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 16, 2021

Study Start

January 15, 2021

Primary Completion

July 31, 2023

Study Completion

December 31, 2023

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)