Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine against XBB.1.5, BA.2.86, and JN.1 Sublineages: A Phase 2/3 Trial

Juleen Gayed
* ,
Vishva Bangad
,
Xia Xu
,
Federico Mensa
,
Mark Cutler
,
Özlem Türeci
,
Uǧur Şahin
,
Kayvon Modjarrad
,
Kena A. Swanson
,
Annaliesa S. Anderson
,
Alejandra Gurtman
,
Nicholas Kitchin
ORCID logo
Version 1 : Received: 16 April 2024 / Approved: 17 April 2024 / Online: 17 April 2024 (08:24:22 CEST)

How to cite: Gayed, J.; Bangad, V.; Xu, X.; Mensa, F.; Cutler, M.; Türeci, Ö.; Şahin, U.; Modjarrad, K.; Swanson, K.A.; Anderson, A.S.; Gurtman, A.; Kitchin, N. Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine against XBB.1.5, BA.2.86, and JN.1 Sublineages: A Phase 2/3 Trial . Preprints 2024, 2024041119. https://doi.org/10.20944/preprints202404.1119.v1 Gayed, J.; Bangad, V.; Xu, X.; Mensa, F.; Cutler, M.; Türeci, Ö.; Şahin, U.; Modjarrad, K.; Swanson, K.A.; Anderson, A.S.; Gurtman, A.; Kitchin, N. Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine against XBB.1.5, BA.2.86, and JN.1 Sublineages: A Phase 2/3 Trial . Preprints 2024, 2024041119. https://doi.org/10.20944/preprints202404.1119.v1

Abstract

We report neutralization titer data against contemporary SARS-CoV-2 sublineages from an ongoing, open-label, phase 2/3 trial of a single 30-μg dose of monovalent Omicron XBB.1.5-adapted BNT162b2 vaccine. Healthy participants had previously received ≥3 doses of a US-authorized mRNA vaccine, with the most recent being a bivalent Omicron BA.4/BA.5-adapted vaccine administered ≥150 days before study vaccination. In this analysis, Omicron XBB.1.5, BA.2.86, and JN.1 serum neutralizing titers were assessed at baseline and 1 month after vaccination in a subset of ≥18-year-olds (N = 40) with evidence of previous SARS-CoV-2 infection. Immunogenicity was also evaluated in a demographically matched group of participants who received bivalent BA.4/BA.5-adapted BNT162b2 in another study (ClinicalTrials.gov Identifier: NCT05472038). The XBB.1.5-adapted BNT162b2 vaccine elicited higher XBB.1.5, BA.2.86, and JN.1 neutralizing titers than those elicited by bivalent BA.4/BA.5-adapted BNT162b2. Overall geometric mean fold rises in neutralizing titers from baseline to 1 month after vaccination were higher among participants who received XBB.1.5-adapted BNT162b2 than those who received bivalent BA.4/BA.5-adapted BNT162b2 for XBB.1.5 (7.6 vs 5.6), slightly higher for JN.1 (3.9 vs 3.5), and similar for BA.2.86 (4.8 vs 4.9). ClinicalTrials.gov Identifier: NCT05997290.

Keywords

BA.2.86; BNT162b2; booster; COVID-19; JN.1; Omicron; SARS-CoV-2; vaccine; variant-adapted; XBB.1.5

Subject

Public Health and Healthcare, Primary Health Care

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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