Impact of the immune system on response to COVID-19 vaccine in allogeneic stem cell recipients

Impact of the immune system on response to COVID-19 vaccine in allogeneic stem cell recipients - Cov-Allo

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000673-83-BE

Enrollment

Registered

2021-02-19

Start date

2021-03-11

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Allogeneic hematopoietic stem cell recipients

Interventions

Trade Name: Comirnaty Product Name: COMIRNATY Pharmaceutical Form: Dispersion for injection INN or Proposed INN: Comirnaty Current Sponsor code: Pfizer Manufacturing Belgium NV Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Full protocol (3 vaccines, n=50) - prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type); patients > 5 years are also eligible if they are still on systemic immunosuppressive treatment. - age> or = 18years at inclusion. - written informed consent Third dose vaccine only (n=20) - Prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type); patients > 5 years are also eligible if they are still on systemic immunosuppressive treatment. - age > or = 18years at inclusion. - written informed consent - Prior vaccination with 2 doses of the Comirnaty® vaccine after allo-HCT 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 20

Exclusion criteria

Exclusion criteria: Full protocol (3 vaccines, n=50) - HIV seropositivity - Pregnancy - Active malignant disease at inclusion - Current grade III-IV acute GVHD - In vitro T-cell depletion of the graft if vaccination within the 6 months after transplantation. - Rituximab administration in the 6 months prior to study inclusion - Prior documented COVID-19 infection occurring after allo-HCT Third dose vaccine only (n=20) - HIV seropositivity - Pregnancy - Active malignant disease at inclusion - Current grade III-IV acute GVHD - Rituximab administration in the 6 months prior to study inclusion for the third dose - Subjects who were not previously vaccinated with a COVID-19 vaccine according to the scheme mentioned above - Subjects who already received a third booster dose of a COVID-19 vaccine - Prior documented COVID-19 infection occurring after allo-HCT

Design outcomes

Primary

Measure	Time frame
Main Objective: Our central question is whether allo-HCT recipients can develop protective immunity against COVID-19 upon vaccination. This question would help the hematologist to provide recommendation/best treatment for these patients. In this pilot project Cov-Allo, this question will be addressed in a cohort in which allo-HCT recipients will be vaccinated with the mRNA available COVID-19 vaccine according to the Belgian vaccination program. The primary objective is to assess immune response after administration of the vaccine (Comirnaty®; Pfizer-BioNTech) in a population of 50 patients allo-HCT recipients. A co-primary objective is to assess immune response to a third dose of the Comirnaty® vaccine these 50 patients as well as in another 20 allo-patients previously given two doses of the Comirnaty® vaccine outside of the current study. ;Secondary Objective: Full protocol (n=50) •To study the evolution and duration of immune response after vaccination (analyze anti-RBD IgG titers performed on days 0 and 28 after third dose and at 6 and 12 months •analyze the titer of neutralizing antibodies 28 days after the second dose as well as days 0, 28 and at 6 and 12 months after the third dose •To investigate the safety of the Comirnaty vaccine. Safety will be reported in terms of incidence and severity of systemic adverse events (AEs) Third dose vaccine only (n=20) •To study the evolution and duration of the immune response after vaccination (analyze anti-RBD IgG titers performed at day 28, 6 months and 12 months after the third dose) •investigate the efficacy of immune response (assessed by the SARS-Cov2 infection rate based on information collected through questionnaires on incidence of documented SARS-CoV-2 infection within12 months after the third dose) •investigate the safety of a third dose of the Comirnaty® vaccine;Primary end point(s): There are two co-primary endpoints First co-primary endpoint The first primary endpoint is the quantification of different a	—

Measure

Time frame

Main Objective: Our central question is whether allo-HCT recipients can develop protective immunity against COVID-19 upon vaccination. This question would help the hematologist to provide recommendation/best treatment for these patients. In this pilot project Cov-Allo, this question will be addressed in a cohort in which allo-HCT recipients will be vaccinated with the mRNA available COVID-19 vaccine according to the Belgian vaccination program. The primary objective is to assess immune response after administration of the vaccine (Comirnaty®; Pfizer-BioNTech) in a population of 50 patients allo-HCT recipients. A co-primary objective is to assess immune response to a third dose of the Comirnaty® vaccine these 50 patients as well as in another 20 allo-patients previously given two doses of the Comirnaty® vaccine outside of the current study. ;Secondary Objective: Full protocol (n=50) •To study the evolution and duration of immune response after vaccination (analyze anti-RBD IgG titers performed on days 0 and 28 after third dose and at 6 and 12 months •analyze the titer of neutralizing antibodies 28 days after the second dose as well as days 0, 28 and at 6 and 12 months after the third dose •To investigate the safety of the Comirnaty vaccine. Safety will be reported in terms of incidence and severity of systemic adverse events (AEs) Third dose vaccine only (n=20) •To study the evolution and duration of the immune response after vaccination (analyze anti-RBD IgG titers performed at day 28, 6 months and 12 months after the third dose) •investigate the efficacy of immune response (assessed by the SARS-Cov2 infection rate based on information collected through questionnaires on incidence of documented SARS-CoV-2 infection within12 months after the third dose) •investigate the safety of a third dose of the Comirnaty® vaccine;Primary end point(s): There are two co-primary endpoints First co-primary endpoint The first primary endpoint is the quantification of different a

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Secondary

Measure	Time frame
Secondary end point(s): Full protocol (n=50) • To study the evolution and duration of the immune response after vaccination: using serology assays to analyze anti-RBD IgG titers performed at day of the third dose and on days 0 and 28 after third dose and at 6 months and 12 months after the third dose. • To analyze the titer of neutralizing antibodies 28 days after the second dose as well as 0 days, 28 days, and at 6 and 12 months after the third dose. o This will be assessed by the capacity of the antibodies to neutralize an infection with SARS-CoV-2 or pseudoviral particles in vitro. These methodologies are established and available at the laboratory of Sciensano (Isabelle Desombere; Co-worker of Cov-Allo). • To identify factors predicting response to vaccine in allo-HCT recipients. • To investigate the efficacy of the immune response. This will be assessed by the SARS-Cov2 infection rate based on information collected through questionnaires on incidence of (PCR-confirmed) SARS-CoV-2 infection within a time-frame from study inclusion to of 12 months after the start of the studythird dose. • In depth assessment of the immune response: by measuring the SARS-Cov2 specific T and B cell response and its evolution and longevity by sampling blood at different time points (B-cell immunity 7 days after the second dose (test performed at Sciensano), T-cell immunity 28 days after the second and the third doses). • To investigate the safety of the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®). Safety will be reported in terms of incidence and severity of systemic adverse events (AEs). Adverse events will also be analyzed in terms of seriousness, relatedness, and expended or not. Incidence and nature of newly occurring immune related AEs of grade = 3 according to the Common Terminology Criteria for Adverse Events version 5.0 including information on vaccine specific safety. Third dose vaccine only (n=20) • To study the evolution and duration of the immune response after vacc	—

Measure

Time frame

Secondary end point(s): Full protocol (n=50) • To study the evolution and duration of the immune response after vaccination: using serology assays to analyze anti-RBD IgG titers performed at day of the third dose and on days 0 and 28 after third dose and at 6 months and 12 months after the third dose. • To analyze the titer of neutralizing antibodies 28 days after the second dose as well as 0 days, 28 days, and at 6 and 12 months after the third dose. o This will be assessed by the capacity of the antibodies to neutralize an infection with SARS-CoV-2 or pseudoviral particles in vitro. These methodologies are established and available at the laboratory of Sciensano (Isabelle Desombere; Co-worker of Cov-Allo). • To identify factors predicting response to vaccine in allo-HCT recipients. • To investigate the efficacy of the immune response. This will be assessed by the SARS-Cov2 infection rate based on information collected through questionnaires on incidence of (PCR-confirmed) SARS-CoV-2 infection within a time-frame from study inclusion to of 12 months after the start of the studythird dose. • In depth assessment of the immune response: by measuring the SARS-Cov2 specific T and B cell response and its evolution and longevity by sampling blood at different time points (B-cell immunity 7 days after the second dose (test performed at Sciensano), T-cell immunity 28 days after the second and the third doses). • To investigate the safety of the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®). Safety will be reported in terms of incidence and severity of systemic adverse events (AEs). Adverse events will also be analyzed in terms of seriousness, relatedness, and expended or not. Incidence and nature of newly occurring immune related AEs of grade = 3 according to the Common Terminology Criteria for Adverse Events version 5.0 including information on vaccine specific safety. Third dose vaccine only (n=20) • To study the evolution and duration of the immune response after vacc

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Countries

Belgium

Contacts

Public ContactClinical Trials Information

CHU de Liège

f.baron@ulg.ac.be3243667201

Outcome results

None listed

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