Third dose of the BNT162b2 vaccine in heart transplant recipients: Immunogenicity and clinical experience.


Journal

The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation
ISSN: 1557-3117
Titre abrégé: J Heart Lung Transplant
Pays: United States
ID NLM: 9102703

Informations de publication

Date de publication:
02 2022
Historique:
received: 12 08 2021
revised: 20 08 2021
accepted: 22 08 2021
pubmed: 28 9 2021
medline: 3 2 2022
entrez: 27 9 2021
Statut: ppublish

Résumé

The repeated waves of the COVID-19 pandemic have highlighted the necessity to optimize vaccine responses in immunocompromised populations. We investigated the safety and immunogenicity of a third, booster, dose of the Pfizer BNT162b2 vaccine in heart transplant (HT) patients. The cohort comprised 96 adult HT patients who received a third homologous dose of the BNT162b2 vaccine 168 days after the second dose. The vaccine-induced antibody responses of both receptor-binding domain (RBD) IgG and neutralizing antibodies were assessed in all patients, with a positive antibody response being defined as the presence of either IgG anti-RBD or neutralizing antibodies. For a subset of patients, T cell response was also studied. The third dose was associated with a low rate of adverse events, mostly mild pain at the injection site. No serious adverse events were recorded, and there were no episodes of rejection. At 18 days following the third dose of the vaccine, the positive antibody response increased from 23% to 67%, with a corresponding increase in neutralizing capacity. The third dose elicited SARS-CoV-2 neutralization titers >9-fold and IgG anti-RBD antibodies >3-fold of the range achieved after the two primary doses. Mycophenolate use, lower eGFR and higher C-reactive protein were independently associated with a reduced likelihood of generating an immune response. Importantly, a specific T-cell response following the third dose was evident in the majority of transplant recipients. An homologous third booster dose of the BNT162b2 vaccine gave overall consistent tolerability and a good safety profile, while eliciting humoral and cellular immune responses.

Sections du résumé

BACKGROUND
The repeated waves of the COVID-19 pandemic have highlighted the necessity to optimize vaccine responses in immunocompromised populations. We investigated the safety and immunogenicity of a third, booster, dose of the Pfizer BNT162b2 vaccine in heart transplant (HT) patients.
METHODS
The cohort comprised 96 adult HT patients who received a third homologous dose of the BNT162b2 vaccine 168 days after the second dose. The vaccine-induced antibody responses of both receptor-binding domain (RBD) IgG and neutralizing antibodies were assessed in all patients, with a positive antibody response being defined as the presence of either IgG anti-RBD or neutralizing antibodies. For a subset of patients, T cell response was also studied.
RESULTS
The third dose was associated with a low rate of adverse events, mostly mild pain at the injection site. No serious adverse events were recorded, and there were no episodes of rejection. At 18 days following the third dose of the vaccine, the positive antibody response increased from 23% to 67%, with a corresponding increase in neutralizing capacity. The third dose elicited SARS-CoV-2 neutralization titers >9-fold and IgG anti-RBD antibodies >3-fold of the range achieved after the two primary doses. Mycophenolate use, lower eGFR and higher C-reactive protein were independently associated with a reduced likelihood of generating an immune response. Importantly, a specific T-cell response following the third dose was evident in the majority of transplant recipients.
CONCLUSIONS
An homologous third booster dose of the BNT162b2 vaccine gave overall consistent tolerability and a good safety profile, while eliciting humoral and cellular immune responses.

Identifiants

pubmed: 34565682
pii: S1053-2498(21)02481-5
doi: 10.1016/j.healun.2021.08.010
pmc: PMC8397500
pii:
doi:

Substances chimiques

Antibodies, Viral 0
BNT162 Vaccine N38TVC63NU

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

148-157

Informations de copyright

Copyright © 2021 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Disclosure statement None of the authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.

Auteurs

Yael Peled (Y)

Leviev Cardiothoracic and Vascular Center, Sheba Medical Center, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: yaelpotash@gmail.com.

Eilon Ram (E)

Leviev Cardiothoracic and Vascular Center, Sheba Medical Center, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Jacob Lavee (J)

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Amit Segev (A)

Leviev Cardiothoracic and Vascular Center, Sheba Medical Center, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Shlomi Matezki (S)

Leviev Cardiothoracic and Vascular Center, Sheba Medical Center, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Anat Wieder-Finesod (A)

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Infectious Disease Unit, Sheba Medical Center, Ramat Gan, Israel.

Rebecca Halperin (R)

Infectious Disease Unit, Sheba Medical Center, Ramat Gan, Israel.

Michal Mandelboim (M)

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Central Virology Laboratory, Ministry of Health, Tel-Hashomer, Israel.

Victoria Indenbaum (V)

Central Virology Laboratory, Ministry of Health, Tel-Hashomer, Israel.

Itzchak Levy (I)

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Infectious Disease Unit, Sheba Medical Center, Ramat Gan, Israel.

Leonid Sternik (L)

Leviev Cardiothoracic and Vascular Center, Sheba Medical Center, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Ehud Raanani (E)

Leviev Cardiothoracic and Vascular Center, Sheba Medical Center, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Arnon Afek (A)

Leviev Cardiothoracic and Vascular Center, Sheba Medical Center, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Yitshak Kreiss (Y)

Leviev Cardiothoracic and Vascular Center, Sheba Medical Center, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Yaniv Lustig (Y)

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Central Virology Laboratory, Ministry of Health, Tel-Hashomer, Israel.

Galia Rahav (G)

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Infectious Disease Unit, Sheba Medical Center, Ramat Gan, Israel.

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Classifications MeSH