COVID-19 vaccine induced immune response in patients with primary antibody deficiency

COVID-19 vaccine induced immune response in patients with primary antibody deficiency - HyCo

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004891-33-FI

Enrollment

Registered

2022-03-09

Start date

2022-04-13

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

COVID-19

Interventions

Trade Name: Comirnaty Product Name: Comirnaty, active substance tozinameran Pharmaceutical Form: Concentrate and solvent for suspension for injection INN or Proposed INN: Tozinameran Trade Name: Vaxz

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients witn primary hypogammaglobulinemia. Age at least 18 years. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Age under 18

Design outcomes

Primary

Measure	Time frame
Main Objective: Immune response induced by Covid-19 vaccine;Secondary Objective: Among study subjects, who have received one, two, three or in the future possibly four or more SARS-CoV-2 -vaccinations What is the number and proportion of subjects with SARS-COV-2 specific antibody response, what is the antibody response of serological type - How long does the response last - The number of SARS-CoV-2 -infections during follow-up after vaccinations What is the number and proportion of subjects with SARS-COV-2 specific cellular immune response, what characteristics does the response present - How long does the response last - The number of SARS-CoV-2 -infections during follow-up after vaccinations;Primary end point(s): Immune response to Covid-19 vaccines. Vaccine induced humoral and cellular immunity to COVID-19.;Timepoint(s) of evaluation of this end point: Before and 3-12 weeks after primary and secondary dose of the vaccination and every 3 months after that.	—

Measure

Time frame

Main Objective: Immune response induced by Covid-19 vaccine;Secondary Objective: Among study subjects, who have received one, two, three or in the future possibly four or more SARS-CoV-2 -vaccinations What is the number and proportion of subjects with SARS-COV-2 specific antibody response, what is the antibody response of serological type - How long does the response last - The number of SARS-CoV-2 -infections during follow-up after vaccinations What is the number and proportion of subjects with SARS-COV-2 specific cellular immune response, what characteristics does the response present - How long does the response last - The number of SARS-CoV-2 -infections during follow-up after vaccinations;Primary end point(s): Immune response to Covid-19 vaccines. Vaccine induced humoral and cellular immunity to COVID-19.;Timepoint(s) of evaluation of this end point: Before and 3-12 weeks after primary and secondary dose of the vaccination and every 3 months after that.

—

Secondary

Measure	Time frame
Secondary end point(s): Immune response to Covid-19 vaccines. Vaccine induced humoral and cellular immunity to COVID-19. - Duration of the immunity - Immune response after second of further vaccination doses - Differences of immuneresponses induced by COVID-19 infection and vaccination;Timepoint(s) of evaluation of this end point: 3-12 after each vaccination and every 3 months after that.	—

Countries

Finland

Contacts

Public ContactLeena Kainulainen

Turku University Hospital

leena.kainulainen@tyks.fi+35823130000

Outcome results

None listed

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