NCT04920357

Immune Response to Vaccination Against Covid-19, a Follow up Study

CoVacc - Immune Response to Vaccination Against Covid-19, an Open Multicenter Phase IV Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Vaccination; Infection
• Covid19

Interventions

Type	Name	Description
DRUG	Vaccination	Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.

Timeline

• Start date: 2021-03-31
• Primary completion: 2022-03-31
• Completion: 2024-12-31
• First posted: 2021-06-09
• Last updated: 2021-06-09

Locations

5 sites across 1 country: Sweden

Regulatory

• FDA-regulated drug study