NCT04858607

Humoral and Cellular Immune Response to COVID-19 Vaccines in Immunocompromised and Healthy Individuals

Humoral and Cellular Immune Response to COVID-19 Vaccines in Immunocompromised and Healthy Individuals - The CoVVac Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 373 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

Currently, the efficacy of COVID-19 vaccination in immunodeficient patients is unknown. Here the investigators aim to evaluate the efficacy of COVID-19 vaccines in immunodeficient patients compared to healthy controls. The investigators will assess the humoral and cellular response to COVID-19 vaccination in these subjects in detail. Furthermore, factors associated with good response to vaccination will be identified. The results of this study will help to guide future recommendations on COVID-19 vaccination in this population.

Detailed description

The total duration of the study is 38 months, starting in March 2021 with a recruiting period until 31. December 2021 and termination of all scheduled visits until 31 May 2024. Individuals having consented and fulfilling the inclusion and exclusion criteria are included in the trial. A baseline visit will take place up to 60 days before the planned date of vaccination according to the Austrian vaccination plan. Scheduled vaccination with any COVID-19 vaccine approved in Austria will allow recruitment. If appropriate pre-vaccine samples from study participants exist in the biobank of the Medical University of Graz, patients may also be included in the study after vaccination starting with visit 3. In this case the biomaterial available at the biobank will be used for the analyses planned on visit 1. The investigators will not influence the date of vaccination or the type of the vaccine used. After first vaccination a telephone visit (visit 2) will assess adverse events and schedule visit 3 at the appropriate time after the second vaccination. At visit 3 the patient's vaccination certificate will be checked to verify correct vaccination and document the type of vaccine received. Further visits (5-6) will be performed for up to two years after the second vaccination. This follow-up period will allow an assessment of the duration of the immune response. The data recorded directly on the Case Report Form (CRF) are considered to be source data. COVID-19 vaccination, COVID-19 infection, Vaccination history, Pregnancy test, Adverse Events, BMI (Body Mass Index), and Laboratory Specimen Collection are recorded directly on the CRF and therefore are considered to be source data. Data will be merged in an electronic database (RDA Research, Documentation \& Analysis; Medical University of Graz, version 07.03.2019). Case Report Forms (CRFs) will be inspected in respect of their accuracy and completeness and compared to original data by the monitor.

Conditions

• Covid19
• Immunosuppression

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood sample	Serology, immune status, T cell immunity, and T cell aging.
DIAGNOSTIC_TEST	Saliva sample	Antibody tests

Timeline

• Start date: 2021-04-19
• Primary completion: 2023-01-20
• Completion: 2023-01-20
• First posted: 2021-04-26
• Last updated: 2023-02-09

Locations

1 site across 1 country: Austria