Abstract
Background: Defining immune correlates of protection against COVID-19 is pivotal for optimizing the use of COVID-19 vaccines, predicting the impact of novel variants on clinical outcomes, and advancing the development of immunotherapies and next-generation vaccines. We aimed to identify vaccine-induced immune correlates of protection against COVID-19-related hospitalizations in a highly vaccinated heart transplant (HT) cohort. Methods: In a case-control study of HT recipients vaccinated with the BNT162b2 vaccine, patients were prospectively assessed for vaccine-induced neutralization of the wild-type virus, and the Delta and Omicron BA.1, BA.2, BA.4, and BA.5 variants. Comparative analyses with controls were conducted to identify correlates of protection against COVID-19 hospitalization. ROC analyses were performed. Primary outcomes were COVID-19 hospitalizations and severity of SARS-CoV-2 breakthrough infection. Results: The study cohort comprised 59 HT recipients aged 58 (49,65) years with breakthrough infections after three or four monovalent BNT162b2 doses; 41 (69.5%) were men. Thirty-six (61%) patients with COVID-19 were hospitalized; most cases were non-severe (58, 98%). For hospitalized (vs. non-hospitalized) COVID-19 patients, vaccine-induced neutralization titers were significantly lower against all SARS-CoV-2 variants (p <.005). Vaccine-induced neutralization of the wild-type virus and delta and omicron BA.1, BA.2, BA.4, and BA.5 variants was associated with a reduced risk for COVID-19-related hospitalization. The optimal neutralization titer thresholds that were predictive of COVID-19 hospitalizations were 96 (wild-type), 48 (delta), 12 (BA.1), 96 (BA.2), 96 (BA.4), and 48 (BA.5). Conclusions: BNT162b2-vaccine-induced neutralization responses are immune correlates of protection and confer clinical protection against COVID-19 hospitalizations.
| Original language | English |
|---|---|
| Article number | e15091 |
| Journal | Clinical Transplantation |
| Volume | 37 |
| Issue number | 11 |
| Early online date | 12 Aug 2023 |
| DOIs | |
| State | Published - Nov 2023 |
| Externally published | Yes |
Bibliographical note
Publisher Copyright:© 2023 The Authors. Clinical Transplantation published by John Wiley & Sons Ltd.
Funding
The vaccination effort for our cohort was organized and coordinated by a dedicated team at the Heart Transplant Unit, Sheba Medical Center: Ms. Hana Algazi-Patal, Ms. Sarit Skiano, Ms. Michal Kelishek, Ms. Merav Moreno, Ms. Tal Aharon, Ms. Eitana Mor, and Mr. Aharon Greitzer. The authors gratefully acknowledge their invaluable contribution to the success of this effort. The authors also thank Ms. Tal Ovdat, MSc, for the statistical analysis and Ms. Inez Mureinik, BSc (Pharm), for her careful reading of the manuscript. Dr Yael Peled had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being
Keywords
- BNT162b2 vaccine
- SARS-CoV-2
- correlates
- heart transplantation
- neutralization
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