Saxon SARS-CoV-2 Infection and Vaccination Study in Dialysis Patients, Solid Organ Recipients and Staff (DIA-Vacc)

August 2, 2022 updated by: Susanne Dollfus, Technische Universität Dresden

Investigation of the Immune Response Before and After COVID-19 Disease or SARS-CoV-2 Vaccination in Dialysis Patients, Solid Organ Recipients and Medical Staff

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

  • Formation of two separate cohorts of approximately 1000 study subjects each from the three categories (dialysis patients, solid organ transplant recipients and medical staff) of participants vaccinated using either Biontech or Moderna vaccine (Biontech cohort and Moderna cohort, approximately 2000 subjects total).
  • Study time points: Before administration of the 1st SARS-CoV-2 vaccine dose, before the 2nd vaccine dose, and 8 weeks and 6, 9, 12, and 18 months after administration of the 1st vaccine dose and after suspected or proven SARS-CoV-2 infection.
  • At all time points, a questionnaire or eCRF will be completed with questions about the dialysis center and the clinical course of the patients.
  • Humoral immune response will be determined in all study participants.
  • Formation of a study subgroup of up to 300 subjects in each cohort (Biontech or Moderna cohort) for detailed evaluation of the cellular immune response (max. 600 subjects in total).
  • In case of non-sustained immunity > 6 months as well as the occurrence of a 3rd SARS-CoV-2 infection wave in autumn 2021, this will be investigated analogously to the current wave.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

2000-3000 subjects

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Immune response to SARS-CoV-2 infection or vaccination
Time Frame: 3 to 4 weeks after vaccination or infection
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
Time Frame: 8 weeks after vaccination or infection
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
Time Frame: 4 months after vaccination or infection
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
Time Frame: 6 months after vaccination or infection
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
Time Frame: 9 months after vaccination or infection
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
Time Frame: 12 months after vaccination or infection
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
Time Frame: 15 months after vaccination or infection
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
Time Frame: 18 months after vaccination or infection
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
Time Frame: 21 months after vaccination or infection
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
Time Frame: 24 months after vaccination or infection
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
Time Frame: 3 to 4 weeks after vaccination or infection
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
Time Frame: 8 weeks after 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
Time Frame: 4 months after 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
Time Frame: 6 months after 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
Time Frame: 9 months after 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
Time Frame: 12 months after 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
Time Frame: 15 months after 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
Time Frame: 18 months after 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
Time Frame: 21 months after 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
Time Frame: 24 months after 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
Time Frame: 3 to 4 weeks after 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
Time Frame: 8 weeks after 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
Time Frame: 4 months after 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
Time Frame: 6 months after 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
Time Frame: 9 months after 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
Time Frame: 12 months after 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
Time Frame: 15 months after 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
Time Frame: 18 months after 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
Time Frame: 21 months after 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
Time Frame: 24 months after 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 incidence and prevalence
Time Frame: 3 to 4 weeks after infection or vaccination
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
3 to 4 weeks after infection or vaccination
SARS-CoV-2 incidence and prevalence
Time Frame: 8 weeks after infection or vaccination
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
8 weeks after infection or vaccination
SARS-CoV-2 incidence and prevalence
Time Frame: 4 months after infection or vaccination
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
4 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Time Frame: 6 months after infection or vaccination
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
6 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Time Frame: 9 months after infection or vaccination
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
9 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Time Frame: 12 months after infection or vaccination
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
12 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Time Frame: 15 months after infection or vaccination
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
15 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Time Frame: 18 months after infection or vaccination
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
18 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Time Frame: 21 months after infection or vaccination
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
21 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Time Frame: 24 months after infection or vaccination
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
24 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Time Frame: 3 to 4 weeks after infection or vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
3 to 4 weeks after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Time Frame: 8 weeks after infection or vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
8 weeks after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Time Frame: 4 months after infection or vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
4 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Time Frame: 6 months after infection or vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
6 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Time Frame: 9 months after infection or vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
9 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Time Frame: 12 months after infection or vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
12 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Time Frame: 15 months after infection or vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
15 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Time Frame: 18 months after infection or vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
18 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Time Frame: 21 months after infection or vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
21 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Time Frame: 24 months after infection or vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
24 months after infection or vaccination
Strength of immune response
Time Frame: 3 to 4 weeks after infection or vaccination
Assessment of the quantity and specificity of the immune response
3 to 4 weeks after infection or vaccination
Strength of immune response
Time Frame: 8 weeks after infection or vaccination
Assessment of the quantity and specificity of the immune response
8 weeks after infection or vaccination
Strength of immune response
Time Frame: 4 months after infection or vaccination
Assessment of the quantity and specificity of the immune response
4 months after infection or vaccination
Strength of immune response
Time Frame: 6 months after infection or vaccination
Assessment of the quantity and specificity of the immune response
6 months after infection or vaccination
Strength of immune response
Time Frame: 9 months after infection or vaccination
Assessment of the quantity and specificity of the immune response
9 months after infection or vaccination
Strength of immune response
Time Frame: 12 months after infection or vaccination
Assessment of the quantity and specificity of the immune response
12 months after infection or vaccination
Strength of immune response
Time Frame: 15 months after infection or vaccination
Assessment of the quantity and specificity of the immune response
15 months after infection or vaccination
Strength of immune response
Time Frame: 18 months after infection or vaccination
Assessment of the quantity and specificity of the immune response
18 months after infection or vaccination
Strength of immune response
Time Frame: 21 months after infection or vaccination
Assessment of the quantity and specificity of the immune response
21 months after infection or vaccination
Strength of immune response
Time Frame: 24 months after infection or vaccination
Assessment of the quantity and specificity of the immune response
24 months after infection or vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Time Frame: 3 to 4 weeks after vaccination
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
3 to 4 weeks after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Time Frame: 8 weeks after vaccination
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
8 weeks after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Time Frame: 4 months after vaccination
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
4 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Time Frame: 6 months after vaccination
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
6 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Time Frame: 9 months after vaccination
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
9 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Time Frame: 12 months after vaccination
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
12 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Time Frame: 15 months after vaccination
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
15 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Time Frame: 18 months after vaccination
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
18 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Time Frame: 21 months after vaccination
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
21 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Time Frame: 24 months after vaccination
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
24 months after vaccination
SARS-CoV-2 vaccination side effects
Time Frame: 3 to 4 weeks after vaccination
Assessing side effects of the different vaccinations in the study cohorts
3 to 4 weeks after vaccination
SARS-CoV-2 vaccination side effects
Time Frame: 8 weeks after vaccination
Assessing side effects of the different vaccinations in the study cohorts
8 weeks after vaccination
SARS-CoV-2 vaccination side effects
Time Frame: 4 months after vaccination
Assessing side effects of the different vaccinations in the study cohorts
4 months after vaccination
SARS-CoV-2 vaccination side effects
Time Frame: 6 months after vaccination
Assessing side effects of the different vaccinations in the study cohorts
6 months after vaccination
SARS-CoV-2 vaccination side effects
Time Frame: 9 months after vaccination
Assessing side effects of the different vaccinations in the study cohorts
9 months after vaccination
SARS-CoV-2 vaccination side effects
Time Frame: 12 months after vaccination
Assessing side effects of the different vaccinations in the study cohorts
12 months after vaccination
SARS-CoV-2 vaccination side effects
Time Frame: 15 months after vaccination
Assessing side effects of the different vaccinations in the study cohorts
15 months after vaccination
SARS-CoV-2 vaccination side effects
Time Frame: 18 months after vaccination
Assessing side effects of the different vaccinations in the study cohorts
18 months after vaccination
SARS-CoV-2 vaccination side effects
Time Frame: 21 months after vaccination
Assessing side effects of the different vaccinations in the study cohorts
21 months after vaccination
SARS-CoV-2 vaccination side effects
Time Frame: 24 months after vaccination
Assessing side effects of the different vaccinations in the study cohorts
24 months after vaccination
Effectiveness of vaccination on severity and incidence of COVID-19
Time Frame: 3 to 4 weeks after vaccination or infection
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
3 to 4 weeks after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Time Frame: 8 weeks after vaccination or infection
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
8 weeks after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Time Frame: 4 months after vaccination or infection
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
4 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Time Frame: 6 months after vaccination or infection
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
6 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Time Frame: 9 months after vaccination or infection
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
9 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Time Frame: 12 months after vaccination or infection
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
12 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Time Frame: 15 months after vaccination or infection
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
15 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Time Frame: 18 months after vaccination or infection
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
18 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Time Frame: 21 months after vaccination or infection
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
21 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Time Frame: 24 months after vaccination or infection
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
24 months after vaccination or infection
Duration of vaccination effect
Time Frame: 3 to 4 weeks after vaccination
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
3 to 4 weeks after vaccination
Duration of vaccination effect
Time Frame: 8 weeks after vaccination
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
8 weeks after vaccination
Duration of vaccination effect
Time Frame: 4 months after vaccination
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
4 months after vaccination
Duration of vaccination effect
Time Frame: 6 months after vaccination
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
6 months after vaccination
Duration of vaccination effect
Time Frame: 9 months after vaccination
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
9 months after vaccination
Duration of vaccination effect
Time Frame: 12 after vaccination
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
12 after vaccination
Duration of vaccination effect
Time Frame: 15 after vaccination
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
15 after vaccination
Duration of vaccination effect
Time Frame: 18 months after vaccination
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
18 months after vaccination
Duration of vaccination effect
Time Frame: 21 months after vaccination
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
21 months after vaccination
Duration of vaccination effect
Time Frame: 24 months after vaccination
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
24 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Time Frame: 3 to 4 weeks after vaccination
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
3 to 4 weeks after vaccination
Compare vaccination effect in different vaccinations and risk populations
Time Frame: 8 weeks after vaccination
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
8 weeks after vaccination
Compare vaccination effect in different vaccinations and risk populations
Time Frame: 4 months after vaccination
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
4 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Time Frame: 6 months after vaccination
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
6 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Time Frame: 9 months after vaccination
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
9 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Time Frame: 12 months after vaccination
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
12 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Time Frame: 15 months after vaccination
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
15 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Time Frame: 18 months after vaccination
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
18 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Time Frame: 21 months after vaccination
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
21 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Time Frame: 24 months after vaccination
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
24 months after vaccination
Protection of re-boostering if necessary
Time Frame: 3 to 4 weeks after re-boostering
Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection)
3 to 4 weeks after re-boostering
Protection of re-boostering if necessary
Time Frame: 8 weeks after re-boostering
Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection)
8 weeks after re-boostering
Protection of re-boostering if necessary
Time Frame: 4 months after re-boostering
Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection)
4 months after re-boostering
Protection of re-boostering if necessary
Time Frame: 6 months after re-boostering
Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection)
6 months after re-boostering
Protection of re-boostering if necessary
Time Frame: 9 months after re-boostering
Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection)
9 months after re-boostering
Protection of re-boostering if necessary
Time Frame: 12 months after re-boostering
Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection)
12 months after re-boostering
Protection of re-boostering if necessary
Time Frame: 15 months after re-boostering
Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection)
15 months after re-boostering
Protection of re-boostering if necessary
Time Frame: 18 months after re-boostering
Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection)
18 months after re-boostering
Protection of re-boostering if necessary
Time Frame: 21 months after re-boostering
Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection)
21 months after re-boostering
Protection of re-boostering if necessary
Time Frame: 24 months after re-boostering
Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection)
24 months after re-boostering

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technische Universität Dresden

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charite University, Berlin, Germany
Klinikum St. Georg gGmbH
Universitätsklinikum Leipzig
DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Dresden
DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Institut Plauen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Christian Hugo, Prof., Univercity Hospital Carl Gustav Carus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DIA-Vacc-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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