Hospital immunity after SARS-CoV-2 vaccination

Heterogeneity, durability and efficacy of the humoral immune response against SARS-CoV-2 (Covid-19) after hospital-wide vaccination - As-Vac-CoV study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006832-24-BE

Enrollment

2600

Registered

2021-12-23

Start date

2022-01-21

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

efficiency and durability of the humoral immune response after vaccination against SARS-CoV-2

Interventions

Trade Name: Comirnaty COVID-19 mRNA-vaccine Product Name: Corminaty Pharmaceutical Form: Concentrate for solution for injection Trade Name: Spikevax COVID-19-mRNA vaccine Product Name: Spikevax Phar

Eligibility

Sex/Gender

All

Inclusion criteria

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. 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 2500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficiency and durability of the humoral immune response after vaccination against SARS-CoV-2;Secondary Objective: -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;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. ;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.	—

Measure

Time frame

Main Objective: To investigate the efficiency and durability of the humoral immune response after vaccination against SARS-CoV-2;Secondary Objective: -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;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. ;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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Secondary

Measure	Time frame
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. ;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.	—

Measure

Time frame

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. ;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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Countries

Belgium

Contacts

Public ContactPrincipal Investigator

Ziekenhuis Oost-Limburg A.V.

deborah.steensels@zol.be003289324663

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026