COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-006832-24/BE

Ziekenhuis Oost-Limburg A.V. - Principal Investigator

deborah.steensels@zol.be

2021-12-23

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

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.

A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. refusal of informed consent.

3

Ziekenhuis Oost-Limburg A.V.

18

100

Belgium

Health workers

N/A

2600

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.

Dose 3

Phase 4

[{"arm_notes": "second dose and booster", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "second dose and booster", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "second dose and booster", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]