BNT162b2-vaccine-induced neutralization responses are immune correlates of clinical protection against SARS-CoV-2 in heart transplant recipients.

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.

• Authors: Yael Peled, Jignesh K Patel, Ehud Raanani, Ram Eilon, Alexander Fardman, Roy Beigel, Nofar Atari, Limor Kliker, Bayan Abd Elkader, Michal Mandelboim, Arnon Afek
• Journal: Clinical transplantation (Clin Transplant) Vol. 37 Issue 11 Pg. e15091 (11 2023) ISSN: 1399-0012 [Electronic] Denmark
• PMID: 37572313 (Publication Type: Journal Article)
• Copyright: © 2023 The Authors. Clinical Transplantation published by John Wiley & Sons Ltd.

Chemical References

• Antibodies, Viral
• BNT162 Vaccine
• COVID-19 Vaccines
• Vaccines

Topics

• Female
• Humans
• Male
• Antibodies, Viral
• BNT162 Vaccine
• Case-Control Studies
• COVID-19 (epidemiology, prevention & control)
• COVID-19 Vaccines
• Heart Transplantation
• SARS-CoV-2
• Vaccines
• Middle Aged
• Aged