Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04799808
Status:
UNKNOWN
Last Update Posted:
2022-08-04
First Post:
2021-03-08
Brief Title:
Saxon SARS-CoV-2 Infection and Vaccination Study in Dialysis Patients Solid Organ Recipients and Staff
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIA-Vacc
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
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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None