E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
efficiency and durability of the humoral immune response after vaccination against SARS-CoV-2 |
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E.1.1.1 | Medical condition in easily understood language |
Immune response after vaccination against COVID-19 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the efficiency and durability of the humoral immune response after vaccination against SARS-CoV-2 |
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E.2.2 | Secondary objectives of the trial |
- factors predictive for the height and durability of the humoral immune response, including any self-reported side effects after vaccination - risk factors for the lack of humoral immune response after vaccination - difference in immune response after vaccination in individuals with or without a history of SARS-CoV-2 infection, and to determine the relative increase in SARS-CoV-2 S-specific binding antibody titres in participants who were already seropositive at the time of vaccination - impact of the immune response on the incidence of COVID19 infections among hospital staff, on nosocomial transmission to patients, and on hospital outbreaks - correlation of the efficiency of the humoral immune response after full vaccination and incidence and severity of breakthrough infections. - the difference in immune response of breakthrough infection and booster vaccination. - the effect of time between breakthrough infection and booster vaccination on humoral immune response |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Coagulation parameters after vaccination against SARS-CoV-2 - To evaluate the effect of vaccination with Vaxzevria (AstraZeneca) on coagulation parameters - To compare the effect of the different vaccines on anti-PF4 antibody titres - To evaluate coagulation parameters in subjects presenting with breakthrough infection. - To evaluate coagulation parameters in subjects after booster vaccination.
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E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Work at Ziekenhuis Oost-Limburg (ZOL) or at Kinderpsychiatrisch Centrum (KPC). Students will be excluded since the long term follow-up and sampling at 1 year post-vaccination cannot be guaranteed. 2. Being vaccinated against SARS-CoV-2. Participants who did not receive the second or third dose of the vaccine (because of medical reasons or refusal of the vaccine) will not be excluded from the study, unless upon their request. Additional inclusion criteria for the optional coagulation sub study: 3. Participants vaccinated with the AstraZeneca vaccine (ChAdOx1 nCoV-19); willing to provide additional blood samples within the first 3 months (with a target at 8 weeks) after the second dose. 4. Participants presenting with a breakthrough infection; willing to provide additional blood samples at the time of the breakthrough infection. 5. Participants who received a booster vaccine; willing to provide additional blood samples within the first 3 months (with a target at 8 weeks) after the booster dose.
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. refusal of informed consent.
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E.5 End points |
E.5.1 | Primary end point(s) |
SARS-CoV-2 S-specific binding antibody titres. Since the vast majority of participants will have a (very) high antibody titre after vaccination, the samples will be diluted until the exact titre (U/mL) is known. This will allow calculation of the anti-S antibody half-life.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
(i) within the first 3 months (with a target at 8 weeks) after the second dose of a COVID-19 vaccine (ii) during and after breakthrough infection and (iii) within the first 3 months (with a target at 8 weeks) after booster vaccination against SARS-CoV-2. |
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E.5.2 | Secondary end point(s) |
• SARS-CoV-2–binding antibodies specific to the SARS-CoV-2 nucleocapsid protein to control for natural occurring infection • When appropriate and feasible, measurement of (variant specific) neutralising antibodies will be performed. • COVID-19 illness, both primo as reinfection, PCR confirmed up to one year following booster vaccination • Nosocomial transmission events • Participants who lack humoral immunity after vaccination (if present) will be invited for additional immunological evaluation, including cellular immune assays.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
(i) within the first 3 months (with a target at 8 weeks) after the second dose of a COVID-19 vaccine (ii) during and after breakthrough infection and (iii) within the first 3 months (with a target at 8 weeks) after booster vaccination against SARS-CoV-2. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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One year after the administration of the third (booster) dose of a COVID-19 vaccine |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |