Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-09 @ 10:55 PM
Study NCT ID:
NCT04920357
Status:
UNKNOWN
Last Update Posted:
2021-06-09
First Post:
2021-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response to Vaccination Against Covid-19, a Follow up Study
Sponsor:
Umeå University
Organization:
Study Overview
Official Title:
CoVacc - Immune Response to Vaccination Against Covid-19, an Open Multicenter Phase IV Study
Status:
UNKNOWN
Status Verified Date:
2021-06
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:
CoVacc
Brief Summary:
The study investigates the immune response after vaccination in individuals with and without pre-existing immunity to Coronavirus disease (COVID) -19. The participants are followed and sampled up to 4 years after vaccination. Blood samples are collected at different timepoints to analyze immune response.
The aim is to investigate the level of specific antibodies to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) yearly, up to 4 years after vaccination.
The aim is to investigate the level of specific antibodies to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) yearly, up to 4 years after vaccination.
Detailed Description:
The main objective is to investigate if the antibody development to SARS-CoV-2 S protein differ after vaccination in those who have had a previous SARS-CoV-2 infection compared to Covid-19 naive individuals.
The secondary objective is to improve the understanding of the cellular and serological immune response after vaccination against COVID-19 in these groups.
Individuals with and without pre-existing immunity to COVID-19 are included in the study. They are included after informed consent at sites where they receive vaccines against COVID-19 within the national and regional vaccine campaign.
The study includes all approved COVID-19 vaccines with marketing authorization in Sweden.
Persons are enrolled after the first or second dose of vaccination and followed 4 years after vaccination. Blood is collected at inclusion and 3 months, 6 months, 1 year, 2 years, 3 years and 4 years after vaccination to assess the immune response.
Data on sex, age, body mass index, medical history and concomitant medication is collected.
The study is a follow-up study after vaccination and approved by the Swedish Medical Products Agency (EudraCT 2021-000683-30). Regular monitoring of the study is performed by the Clinical Trial unit at Umeå University Hospital.
The secondary objective is to improve the understanding of the cellular and serological immune response after vaccination against COVID-19 in these groups.
Individuals with and without pre-existing immunity to COVID-19 are included in the study. They are included after informed consent at sites where they receive vaccines against COVID-19 within the national and regional vaccine campaign.
The study includes all approved COVID-19 vaccines with marketing authorization in Sweden.
Persons are enrolled after the first or second dose of vaccination and followed 4 years after vaccination. Blood is collected at inclusion and 3 months, 6 months, 1 year, 2 years, 3 years and 4 years after vaccination to assess the immune response.
Data on sex, age, body mass index, medical history and concomitant medication is collected.
The study is a follow-up study after vaccination and approved by the Swedish Medical Products Agency (EudraCT 2021-000683-30). Regular monitoring of the study is performed by the Clinical Trial unit at Umeå University Hospital.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: