Immunogenicity and safety after the third dose of BNT162b2 anti-SARS-CoV-2 vaccine in patients with solid tumors on active treatment: a prospective cohort study.


Journal

ESMO open
ISSN: 2059-7029
Titre abrégé: ESMO Open
Pays: England
ID NLM: 101690685

Informations de publication

Date de publication:
04 2022
Historique:
received: 29 01 2022
revised: 28 02 2022
accepted: 03 03 2022
pubmed: 16 4 2022
medline: 4 5 2022
entrez: 15 4 2022
Statut: ppublish

Résumé

Although a full course of coronavirus disease 2019 (COVID-19) vaccine is effective in cancer patients, the duration of the protection and the efficacy of a booster dose against the new variants remain unknown. We prospectively evaluated the immunogenicity of the third dose of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) BNT162b2 messenger RNA vaccine in cancer patients undergoing active treatment. Patients with solid cancer, vaccinated with a booster dose during active treatment, were enrolled in this study. Patients were classified into SARS-CoV-2 naïve (without previous COVID-19 infection) and SARS-CoV-2 experienced (with previous COVID-19 infection). Neutralizing antibody (NT Ab) titer and total anti-Spike immunoglobulin G (IgG) concentration were quantified in serum. Heparinized whole blood samples were used for SARS-CoV-2 Interferon Gamma Release Assay (IGRA). The primary endpoint was to assess the increase of IgG antibody level between baseline and 3 weeks after the booster. One hundred and forty-two consecutive patients were recruited. In SARS-CoV-2-naïve subjects, the median level of IgG was 157 BAU/ml [interquartile range (IQR) 62-423 BAU/ml] at T0 and reached a median of 2080 BAU/ml (IQR 2080-2080 BAU/ml) at 3 weeks after booster administration (T1; P < 0.0001). A median 16-fold increase of SARS-CoV-2 NT Ab titer (IQR 4-32) was observed in naïve subjects (from median 20, IQR 10-40, to median 640, IQR 160-640; P < 0.0001). Median interferon-γ level at T1 was significantly higher than that measured at T0 in SARS-CoV-2-naïve subjects (P = 0.0049) but not in SARS-CoV-2-experienced patients. The median level of SARS-CoV-2 NT Abs was 32-fold lower against Omicron compared to the wild-type strain (P = 0.0004) and 12-fold lower compared to the Delta strain (P = 0.0110). The third dose is able to trigger both the humoral and the cell-mediated immune response in cancer patients on active treatment. Our preliminary data about the neutralization of the SARS-CoV-2 vaccine against variants of concern seem to confirm the lower vaccine activity.

Sections du résumé

BACKGROUND
Although a full course of coronavirus disease 2019 (COVID-19) vaccine is effective in cancer patients, the duration of the protection and the efficacy of a booster dose against the new variants remain unknown. We prospectively evaluated the immunogenicity of the third dose of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) BNT162b2 messenger RNA vaccine in cancer patients undergoing active treatment.
PATIENTS AND METHODS
Patients with solid cancer, vaccinated with a booster dose during active treatment, were enrolled in this study. Patients were classified into SARS-CoV-2 naïve (without previous COVID-19 infection) and SARS-CoV-2 experienced (with previous COVID-19 infection). Neutralizing antibody (NT Ab) titer and total anti-Spike immunoglobulin G (IgG) concentration were quantified in serum. Heparinized whole blood samples were used for SARS-CoV-2 Interferon Gamma Release Assay (IGRA). The primary endpoint was to assess the increase of IgG antibody level between baseline and 3 weeks after the booster.
RESULTS
One hundred and forty-two consecutive patients were recruited. In SARS-CoV-2-naïve subjects, the median level of IgG was 157 BAU/ml [interquartile range (IQR) 62-423 BAU/ml] at T0 and reached a median of 2080 BAU/ml (IQR 2080-2080 BAU/ml) at 3 weeks after booster administration (T1; P < 0.0001). A median 16-fold increase of SARS-CoV-2 NT Ab titer (IQR 4-32) was observed in naïve subjects (from median 20, IQR 10-40, to median 640, IQR 160-640; P < 0.0001). Median interferon-γ level at T1 was significantly higher than that measured at T0 in SARS-CoV-2-naïve subjects (P = 0.0049) but not in SARS-CoV-2-experienced patients. The median level of SARS-CoV-2 NT Abs was 32-fold lower against Omicron compared to the wild-type strain (P = 0.0004) and 12-fold lower compared to the Delta strain (P = 0.0110).
CONCLUSIONS
The third dose is able to trigger both the humoral and the cell-mediated immune response in cancer patients on active treatment. Our preliminary data about the neutralization of the SARS-CoV-2 vaccine against variants of concern seem to confirm the lower vaccine activity.

Identifiants

pubmed: 35427842
pii: S2059-7029(22)00075-8
doi: 10.1016/j.esmoop.2022.100458
pmc: PMC8913298
pii:
doi:

Substances chimiques

Antibodies, Viral 0
COVID-19 Vaccines 0
Immunoglobulin G 0
Vaccines, Synthetic 0
mRNA Vaccines 0
BNT162 Vaccine N38TVC63NU

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

100458

Informations de copyright

Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Disclosure The authors have declared no conflicts of interest.

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Auteurs

A Lasagna (A)

Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

F Bergami (F)

Molecular Virology Unit, Department of Microbiology and Virology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

D Lilleri (D)

Molecular Virology Unit, Department of Microbiology and Virology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

E Percivalle (E)

Molecular Virology Unit, Department of Microbiology and Virology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

M Quaccini (M)

Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

N Alessio (N)

Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

G Comolli (G)

Molecular Virology Unit, Department of Microbiology and Virology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

A Sarasini (A)

Molecular Virology Unit, Department of Microbiology and Virology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

J C Sammartino (JC)

Molecular Virology Unit, Department of Microbiology and Virology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

A Ferrari (A)

Molecular Virology Unit, Department of Microbiology and Virology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

F Arena (F)

Molecular Virology Unit, Department of Microbiology and Virology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

S Secondino (S)

Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

D Cicognini (D)

Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

R Schiavo (R)

Microbiology Unit, Hospital Guglielmo da Saliceto, Piacenza, Italy.

G Lo Cascio (G)

Microbiology Unit, Hospital Guglielmo da Saliceto, Piacenza, Italy.

L Cavanna (L)

Oncology Unit, Hospital Guglielmo da Saliceto, Piacenza, Italy.

F Baldanti (F)

Molecular Virology Unit, Department of Microbiology and Virology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Departments of Clinical, Surgical, Diagnostic and Pediatric Sciences, Pavia, Italy.

P Pedrazzoli (P)

Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Internal Medicine and Medical Therapy, University of Pavia, Pavia, Italy. Electronic address: p.pedrazzoli@smatteo.pv.it.

I Cassaniti (I)

Molecular Virology Unit, Department of Microbiology and Virology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

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Classifications MeSH