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Antibody Response after BNT162B2 COVID-19 mRNA Vaccination in Cancer Patients Under Anti-Neoplastic Treatment

28 Pages Posted: 16 Jun 2021

See all articles by Marc Peeters

Marc Peeters

University of Antwerp - Multidisciplinary Oncologic Centre Antwerp (MOCA); University of Antwerp - Center for Oncological Research (CORE)

Lise Verbruggen

University of Antwerp

Laure-Anne Teuwen

University of Antwerp

Greetje Vanhoutte

University of Antwerp

Sara Vande Kerckhove

Sciensano

Bart Peeters

University of Antwerp - Antwerp University Hospital (UZA)

Silke Raats

University of Antwerp

Isolde Van der Massen

University of Antwerp

Sven De Keersmaecker

University of Antwerp

Manon Huizing

University of Antwerp - Antwerp University Hospital (UZA)

Pieter Pannus

Sciensano

Kristof Neven

Sciensano

Kevin K. Ariën

Institute of Tropical Medicine (ITM)

Geert Martens

AZ Delta General Hospital - AZ Delta Medical Laboratories

Marc Van Den Bulcke

Sciensano

Ella Roelant

University of Antwerp

Isabelle Desombere

Sciensano

Sébastien Anguille

University of Antwerp

Maria Goossens

Sciensano

Timon Vandamme

University of Antwerp

Peter van Dam

University of Antwerp

More...

Abstract

Background: Cancer patients are at higher risk of developing severe COVID-19. However, safety and efficacy of COVID-19 vaccination in cancer patients undergoing treatment is unclear.

Methods: In this interventional prospective multi-cohort study, priming and booster doses of the BNT162b2 COVID-19 vaccine were administered 21 days apart to solid tumor patients receiving chemotherapy, immunotherapy, targeted- or hormonal therapy, and patients with a hematologic malignancy receiving rituximab or after allogeneic hematopoietic stem cell transplantation. Primary endpoint was anti-SARS-CoV-2 receptor binding domain (RBD) antibody level at 28 days post-booster. Anti-RBD IgG titers above 200 IU/ml was used to define high-responders as it leads to a neutralization response required for 50% protection against symptomatic SARS-CoV-2 infection in 268 independent subjects. Secondary endpoints included self-reported adverse events (AEs), antibody response over time and number of breakthrough infections after vaccination.

Findings: 28 days post-booster vaccination of 197 cancer patients, antibody response was lower in the hematological cohort (geometric mean titer (GMT) 17·61 IU/mL [95% CI 7·17-43·24]) and the chemotherapy cohort (GMT 234·05 IU/mL [95% 95%CI 122·10-448·66]) when compared to healthy individuals (n=40; GMT 1844·93 IU/mL [95% CI 1383·57-2460·14]), irrespective of timing of vaccination during chemotherapy cycles. Only 55% and 7% of patients receiving chemotherapy or rituximab could be categorized as high-responders at 28 days post-booster. During the study period, five subjects tested positive for SARS-CoV-2 infection, including three after full vaccination. Local and systemic AEs were mostly mild to moderate, with only 1-3% of patients experiencing severe AEs.

Local, but not systemic, AEs occurred more frequently after booster than after priming dose.

Interpretation: The BNT162b2 vaccine is well-tolerated in cancer patients under active treatment. However, the antibody response of immunized cancer patients was delayed and diminished, mainly in patients receiving chemotherapy or rituximab, resulting in breakthrough infections.

Trial Registration: EudraCT number 2021-000300-38

Funding: The regulatory sponsor was the Antwerp University Hospital (EudraCT number 2021-000300-38). The trial was funded by the Belgian Government through Sciensano (COVID-19_SC004, COVID- 19_SC059, COVID-19_SC061).

Declaration of Interest: MP declares to have an advisory role within Remedus, all other authors declare no competing interests.

Ethical Approval: The study was approved by the local ethics committee and was executed in accordance with Good Clinical Practice and the Declaration of Helsinki (ICH GCP E6(R2)).

Suggested Citation

Peeters, Marc and Verbruggen, Lise and Teuwen, Laure-Anne and Vanhoutte, Greetje and Vande Kerckhove, Sara and Peeters, Bart and Raats, Silke and Van der Massen, Isolde and De Keersmaecker, Sven and Huizing, Manon and Pannus, Pieter and Neven, Kristof and Ariën, Kevin K. and Martens, Geert and Van Den Bulcke, Marc and Roelant, Ella and Desombere, Isabelle and Anguille, Sébastien and Goossens, Maria and Vandamme, Timon and van Dam, Peter, Antibody Response after BNT162B2 COVID-19 mRNA Vaccination in Cancer Patients Under Anti-Neoplastic Treatment. Available at SSRN: https://ssrn.com/abstract=3868066 or http://dx.doi.org/10.2139/ssrn.3868066

Marc Peeters (Contact Author)

University of Antwerp - Multidisciplinary Oncologic Centre Antwerp (MOCA) ( email )

Antwerp University Hospital
Drie Eikenstraat 655
Edegem, 2650
Belgium
+323 821 43 66 (Phone)

University of Antwerp - Center for Oncological Research (CORE)

Drie Eikenstraat 655
Edegem, 2650
Belgium

Lise Verbruggen

University of Antwerp ( email )

Prinsstraat 13
Antwerp, 2000
Belgium

Laure-Anne Teuwen

University of Antwerp

Prinsstraat 13
Antwerp, 2000
Belgium

Greetje Vanhoutte

University of Antwerp ( email )

Prinsstraat 13
Antwerp, 2000
Belgium

Sara Vande Kerckhove

Sciensano ( email )

Rue Juliette Wytsmanstraat 14
Brussels, 1050
Belgium

Bart Peeters

University of Antwerp - Antwerp University Hospital (UZA) ( email )

Edegem
Belgium

Silke Raats

University of Antwerp ( email )

Prinsstraat 13
Antwerp, 2000
Belgium

Isolde Van der Massen

University of Antwerp ( email )

Prinsstraat 13
Antwerp, 2000
Belgium

Sven De Keersmaecker

University of Antwerp ( email )

Prinsstraat 13
Antwerp, 2000
Belgium

Manon Huizing

University of Antwerp - Antwerp University Hospital (UZA) ( email )

Edegem
Belgium

Pieter Pannus

Sciensano ( email )

Rue Juliette Wytsmanstraat 14
Brussels, 1050
Belgium

Kristof Neven

Sciensano ( email )

Rue Juliette Wytsmanstraat 14
Brussels, 1050
Belgium

Kevin K. Ariën

Institute of Tropical Medicine (ITM) ( email )

B-2000 Antwerp
Belgium

Geert Martens

AZ Delta General Hospital - AZ Delta Medical Laboratories ( email )

Deltalaan
Netherlands

Marc Van Den Bulcke

Sciensano ( email )

Rue Juliette Wytsmanstraat 14
Brussels, 1050
Belgium

Ella Roelant

University of Antwerp

Prinsstraat 13
Antwerp, 2000
Belgium

Isabelle Desombere

Sciensano ( email )

Rue Juliette Wytsmanstraat 14
Brussels, 1050
Belgium

Sébastien Anguille

University of Antwerp ( email )

Prinsstraat 13
Antwerp, 2000
Belgium

Maria Goossens

Sciensano ( email )

Rue Juliette Wytsmanstraat 14
Brussels, 1050
Belgium

Timon Vandamme

University of Antwerp ( email )

Prinsstraat 13
Antwerp, 2000
Belgium

Peter Van Dam

University of Antwerp ( email )

Prinsstraat 13
Antwerp, 2000
Belgium

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