The aim is to study primarily effectiveness as well as safety of citizens being vaccinated with one of the SARS-CoV2 vaccines being applied in the Danish COVID-19 vaccine programme. Whereas ongoing phase III trials are reporting vaccine efficacy in defined study populations, the effectiveness of these vaccines – and in particular the durability hereof - once introduced into the general population is presently unknown, and the focus of intense research and public health interest. MedDRA vers
Conditions
Sponsors
CHIP - Rigshospitalet - University of Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained before any trial related procedures are performed 2. Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan) 3. The subject must be willing and able to comply with trial protocol (re-visits and biological samples) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5000
Exclusion criteria
Exclusion criteria: 1. Male and female under the age of 18 2. Any subgroup of individuals for which the vaccines are contra-indicated 3. Previous SARS-CoV-2 vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess effectiveness of citizens being vaccinated with one of SARS-CoV2 vaccines the government has purchased, and the Danish Medicines Agency has approved for use in Denmark. The study will compare and predict the durability of the minimal protective titre afforded by each of the vaccines against COVID-19 through conducting comprehensive high-throughput SARS-CoV-2 antibody analyses and in-depth characterization of the vaccine-induced cellular immune response;Secondary Objective: In relation to effectiveness, the following outcome will be compared between vaccine groups: •Breakthrough infections throughout the 24 month follow-up period. •A series of more detailed immunological assessment in subgroups of participants of markers of cellular immunity (see appendix 3) In relation to safety, the following outcome will be compared between vaccine groups: •Participants with local and systemic reactions to vaccination •Grade 3 and 4 adverse events and serious adverse events. This will be ascertained and reported by study-affiliated staff. Primary safety outcomes are any grade 3 or 4 (i.e. serious) events observed within the first three months after the initial vaccination. •Grade 1 and 2 events. This will be ascertained by study-affiliated staff as present on the specific day of Visit 2 and Visit 3. ;Primary end point(s): Primary outcome is the minimal protective neutralising antibody titre (MPNAT); i.e. the minimum level of neutralising antibodies sufficient to protect the person from becoming infected. ;Timepoint(s) of evaluation of this end point: MPNAT will be measured via profiling of antibodies against SARS-CoV-2 Spike epitopes performed at each visit until month 24. The exact value of the MPNAT is currently not precisely defined, but is expected to be documented within short periods of time based on analyses across the ongoing phase III trials, associating titre levels with risk of breakthrough infection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): See under objectives;Timepoint(s) of evaluation of this end point: As above | — |
Countries
Denmark
Contacts
Public ContactJens Lundgren
CHIP - Rigshospitalet, University of Copenhagen
Outcome results
None listed