SARS-CoV-2 infections MedDRA version: 20.0 Level: LLT Classification code 10021433 Term: Immunization System Organ Class: 100000004865
Conditions
Sponsors
Medizinische Universität Innsbruck, Institut für Virologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is = 18 years of age on the day of signing the ICF and provides written informed consent or participant is between 16 and 18 years of age and provides informed consent as well as his/her legal representative/custodial 2. Subject has been already vaccinated with Comirnaty (two doses), with the second dose having been administered within up to 6 weeks (35 days ± 7 days) before study inclusion 3. Subject understands and agrees to comply with study procedures 4. Subject must be willing to be contacted by telephone or willing to complete an eDiary during study participation Are the trial subjects under 18? yes Number of subjects for this age range: 340 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: 1. Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to either prevent or treat COVID-19 2. Participant has a contraindication to blood draws (eg, bleeding disorders) 3. Has participated in an interventional clinical study within 30 days prior to study inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to determine whether the level of neutralizing titers at visit 1 differs between individuals that develop a SARS-CoV-2 infection and those that do not develop a SARS-CoV-2 infection ;Secondary Objective: Secondary objective: 1. To compare changes in the level of neutralizing titers between visit 1 vs. visit 2 between individuals that develop a SARS-CoV-2 infection and those that do not develop a SARS-CoV-2 infection 2. To determine the correlation between titers of binding and neutralizing antibodies 3. To quantify the T-cell response and compare it between the two groups 4. To evaluate the clinical course and outcome of COVID-19 diseases after vaccination ;Primary end point(s): The level of neutralizing titers at visit 1 ;Timepoint(s) of evaluation of this end point: Day 1 - day of first blood draw | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The levels of neutralizing titers at visit 1 and 2 2. The levels of titers of binding and neutralizing antibodies 3. The level of interferon-gamma-signal 4. Number of first occurrences of COVID-19 within the observation period defined as it follows: o Clinical signs indicative of mild systemic illness (fever, smell / taste loss, ….) o Clinical signs indicative of severe systemic illness - Respiratory Rate = 30 per minute, Heart Rate = 125 beats per minute, SpO2 = 93% on room air at sea level or PaO2/FIO2 < 300 mm Hg, OR - Respiratory failure or Acute Respiratory Distress Syndrome (ARDS), (defined as needing high-flow oxygen, non-invasive or mechanical ventilation, or ECMO), evidence of shock (systolic blood pressure < 90 mmHg, diastolic BP < 60 mmHg or requiring vasopressors), OR - Significant acute renal, hepatic or neurologic dysfunction, OR - Admission to an intensive care unit or death ;Timepoint(s) of evaluation of this end point: Day 1 (first blood draw, 4 - 6 weeks after second vaccination with comirnaty) and Day 180 (second blood draw) Between those days weekly antigen-tests are performed to detect breakthrough infections | — |
Countries
Austria
Contacts
Public ContactPrincipal Investigator
Medizinische Universität Innsbruck, Institut für Virologie
Outcome results
None listed