Study of immuneresponse after vaccination against SARS-COV-2

COVID-19: Study of the immune response in healthy volunteers after vaccination against SARS-CoV-2 (COVID19-VAX-AZG) and monitoring of breakthrough infections after booster vaccination (COVID19-VAX-DBI-AZG) and study of immune response after booster vaccination with Comirnaty Omicron XBB.1.5 (COVID19-VAX-XBB-AZG) - COVID19-VAX-AZG

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001304-15-BE

Enrollment

Registered

2021-03-16

Start date

2021-05-06

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

immuneresponse after vaccination

Interventions

Trade Name: Comirnaty Pharmaceutical Form: Concentrate and solvent for solution for injection INN or Proposed INN: NAP Current Sponsor code: BNT162b2 Other descriptive name: Tozinameran Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: healthy volunteer older than 18 years no infections at the time of vaccination and first blooddraw 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: individuals infected with SARS-CoV-2 or have already been through a SARS-CoV-2 infection individuals with primary immunedeficiency. Individuals with immune modulating treatment individuals with an anuto immune disease pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: this study's objective is to follow the adaptive immuneresponse (on b and T cell level) enhanced by vaccination. The effect of vaccination in healthy voluneteers on: - induction of virus-specific antibodies - neutralising capabilities of the raised antibodies - the repertoire of the raised antibodies, inclusive epitope mapping by commercially available peptide arrays as in-house developed massspectrometry based bulk profiling of complementary determining regions of antibodies. - the creation of virusspecific memory T and B cells by detailled flowcytometric fenotyping - the possible negative effect of antibody mediated disease enhancement in an in vitro assay that allows measurement of target cel infection. - the subtype SARS-CoV-2 virus that despite vaccination still can lead to infection (viral whole genome sequencing) ;Secondary Objective: description of vaccin induced antibody dependent enhancement identification of vaccine escape mutants ;Primary end point(s): induction of virus-specific antibodies - neutralising capabilities of the raised antibodies - the repertoire of the raised antibodies, inclusive epitope mapping by commercially available peptide arrays as in-house developed massspectrometry based bulk profiling of complementary determining regions of antibodies. - the creation of virusspecific memory T and B cells by detailled flowcytometric fenotyping - the possible negative effect of antibory mediated disease enhancement in an in vitro assay that allows measurement of target cel infection. - the subtype SARS-CoV-2 virus that despite vaccination still can lead to infection (viral whole genome sequencing) ;Timepoint(s) of evaluation of this end point: 3 months and 12 months	—

Measure

Time frame

Main Objective: this study's objective is to follow the adaptive immuneresponse (on b and T cell level) enhanced by vaccination. The effect of vaccination in healthy voluneteers on: - induction of virus-specific antibodies - neutralising capabilities of the raised antibodies - the repertoire of the raised antibodies, inclusive epitope mapping by commercially available peptide arrays as in-house developed massspectrometry based bulk profiling of complementary determining regions of antibodies. - the creation of virusspecific memory T and B cells by detailled flowcytometric fenotyping - the possible negative effect of antibody mediated disease enhancement in an in vitro assay that allows measurement of target cel infection. - the subtype SARS-CoV-2 virus that despite vaccination still can lead to infection (viral whole genome sequencing) ;Secondary Objective: description of vaccin induced antibody dependent enhancement identification of vaccine escape mutants ;Primary end point(s): induction of virus-specific antibodies - neutralising capabilities of the raised antibodies - the repertoire of the raised antibodies, inclusive epitope mapping by commercially available peptide arrays as in-house developed massspectrometry based bulk profiling of complementary determining regions of antibodies. - the creation of virusspecific memory T and B cells by detailled flowcytometric fenotyping - the possible negative effect of antibory mediated disease enhancement in an in vitro assay that allows measurement of target cel infection. - the subtype SARS-CoV-2 virus that despite vaccination still can lead to infection (viral whole genome sequencing) ;Timepoint(s) of evaluation of this end point: 3 months and 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): 3 and 12 months;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Belgium

Contacts

Public ContactClinical trial center

az groeninge

ctckortrijk@azgroeninge.be32566363

Outcome results

None listed

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