Immune response to SARS-CoV-2 in health care workers, previously infected subjects, and immunocompromised subjects, before and after Covid-19 vaccination: a phase IV trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001769-19-SE

Enrollment

1200

Registered

2021-03-29

Start date

2021-04-15

Completion date

Unknown

Last updated

2021-06-07

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

Conditions

SARS-COV-2 infection MedDRA version: 23.0 Level: LLT Classification code 10084272 Term: SARS-CoV-2 infection System Organ Class: 100000004862

Interventions

Trade Name: Comirnaty Pharmaceutical Form: Injection Trade Name: COVID-19 Vaccine Moderna Pharmaceutical Form: Injection Trade Name: COVID-19 Vaccine AstraZeneca Pharmaceutical Form: Injection Trad

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Provided written informed consent Vaccinated against SARS-CoV-2 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 900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Main Objective: Does the humoral immune response after vaccination against Covid-19 differ between immune competent subjects and patients with primary or secondary immune deficiency? ;Secondary Objective: Not applicable;Primary end point(s): SARS-CoV-2-specific serum antibodies;Timepoint(s) of evaluation of this end point: 1 month, 6 months, 12 months and 24 months post primary vaccination	—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Sweden

Contacts

Public ContactClinical Trials Information

GUVAX

anna.lundgren@microbio.gu.se

Outcome results

None listed

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