SARS-CoV-2
Conditions
Keywords
Serology, antibody formation, epidemiology, immunity
Brief summary
The main objectives of this study are 1) to establish the prevalence of SARS-CoV-2 in asymptomatic healthcare workers (HCWs) in an early phase of community spread as well as 2) to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in symptomatic and asymptomatic HCWs over time and 3) to improve the assessment of the immune response and its protective effect as well as the assessment of infectivity of affected HCWs and 4) to evaluate the value and significance of antibody formation and serological antibody tests and 5) to be able to evaluate possible future preventive and / or therapeutic approaches against SARS-CoV-2, e.g. to assess vaccination effects
Detailed description
This study aims to collect information on staff working at the Greifswald University hospital. Over a 5 year period, a maximum of 12 study visits per participant are planned. At each visit, nasal/throat swabs (for PCR testing) and/or blood samples (to assess immunological responses, e.g. for SARS-CoV-2 antibody testing) will be collected. This will help to gain a better understanding of viral load and immunological responses, e.g. antibody development and their effects over time. At study visit 2 - 12, participants will also be asked to fill in a questionnaire (asking for SARS-CoV-2 risk factors, perceived risk, impact of the pandemic on their quality of life, their interest in getting a SARS-CoV-2 vaccine/their SARS-CoV-2 vaccination status and vaccination side effects). The remaining blood samples will be stored in a repository for future research. The study is part of a modular SARS-CoV-2-research programme of the University Medicine Greifswald.
Interventions
DIAGNOSTIC_TESTNasal swab
SARS-CoV-2 PCR
DIAGNOSTIC_TESTSerum testing
Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination
Sponsors
Friedrich Loefler Institute for Animal Health
EUROIMMUN AG
University Medicine Greifswald
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. \>= 18 years of age 2. Willing and able to complete a written consent form 3. Willing to have blood samples stored for future research 4. Healthcare worker employed at Greifswald University Hospital
Exclusion criteria
1. \< 18 years of age 2. Decline to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of people with detectable antibodies to SARS-CoV-2 | 1 year | Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of people with detectable SARS-CoV-2 nucleic acid | First study visit (baseline) | SARS-CoV-2 PCR |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of people with detectable antibodies to SARS-CoV-2 | First study visit (baseline) | Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA |
| Number of people with detectable SARS-CoV-2 nucleic acid | 2 years | SARS-CoV-2 PCR |
| SARS-CoV-2 risk factors, perceived risk of infection, impact of the pandemic on quality of life, vaccination interest/vaccination status, vaccination side effects | 1 year | As assessed by a questionnaire |
| Serological changes after SARS-CoV-2 vaccination | 7 days to 6 months after vaccination | Serological changes after SARS-CoV-2 vaccination, cohort 3 only |
Countries
Germany
Outcome results
None listed