Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Safety and Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine in Individuals ≥12 Years Old: A Phase 2/3 Trial

Juleen Gayed
* ,
Oyeniyi Diya
,
Francine S. Lowry
,
Xia Xu
,
Vishva Bangad
,
Federico Mensa
,
Jing Zou
,
Xuping Xie
ORCID logo ,
Yanping Hu
,
Claire Lu
,
Mark Cutler
,
Todd Belanger
,
David Cooper
,
Kenneth Koury
,
Annaliesa S. Anderson
,
Özlem Türeci
,
Uǧur Şahin
,
Kena A. Swanson
,
Kayvon Modjarrad
,
Alejandra Gurtman
,
Nicholas Kitchin
ORCID logo
Version 1 : Received: 5 January 2024 / Approved: 9 January 2024 / Online: 9 January 2024 (04:43:05 CET)

A peer-reviewed article of this Preprint also exists.

Gayed, J.; Diya, O.; Lowry, F.S.; Xu, X.; Bangad, V.; Mensa, F.; Zou, J.; Xie, X.; Hu, Y.; Lu, C.; Cutler, M.; Belanger, T.; Cooper, D.; Koury, K.; Anderson, A.S.; Türeci, Ö.; Şahin, U.; Swanson, K.A.; Modjarrad, K.; Gurtman, A.; Kitchin, N. Safety and Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine in Individuals ≥12 Years Old: A Phase 2/3 Trial. Vaccines 2024, 12, 118. Gayed, J.; Diya, O.; Lowry, F.S.; Xu, X.; Bangad, V.; Mensa, F.; Zou, J.; Xie, X.; Hu, Y.; Lu, C.; Cutler, M.; Belanger, T.; Cooper, D.; Koury, K.; Anderson, A.S.; Türeci, Ö.; Şahin, U.; Swanson, K.A.; Modjarrad, K.; Gurtman, A.; Kitchin, N. Safety and Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine in Individuals ≥12 Years Old: A Phase 2/3 Trial. Vaccines 2024, 12, 118.

Abstract

Vaccination remains an important mitigation tool against COVID-19. We report 1-month safety and preliminary immunogenicity data from a substudy of an ongoing, open-label, phase 2/3 study of monovalent Omicron XBB.1.5-adapted BNT162b2 (single 30-μg dose). Healthy, participants ≥12 years old (N=412 [12‒17 years, N=30; 18‒55 years, N=174; >55 years, N=208]) who previously received ≥3 doses of a US-authorized mRNA vaccine, the most recent being an Omicron BA.4/BA.5-adapted bivalent vaccine ≥150 days before study vaccination, were vaccinated. Serum 50% neutralizing titers against Omicron XBB.1.5, EG.5.1, and BA.2.86 were measured 7 days and 1 month after vaccination in a subset of ≥18-year-olds (N=40) who were positive for SARS-CoV-2 at baseline. Seven-day immunogenicity was also evaluated in a matched group who received bivalent BA.4/BA.5-adapted BNT162b2 in a previous study (NCT05472038). There were no new safety signals; local reactions and systemic events were mostly mild to moderate in severity, adverse events were infrequent, and none led to study withdrawal. The XBB.1.5-adapted BNT162b2 induced numerically higher titers against Omicron XBB.1.5, EG.5.1, and BA.2.86 than BA.4/BA.5-adapted BNT162b2 at 7 days and robust neutralizing responses to all 3 sublineages at 1 month. These data support a favorable benefit-risk profile of XBB.1.5-adapted BNT162b2 30 μg. NCT05997290

Keywords

BNT162b2; COVID-19; SARS-CoV-2; vaccine; variant-adapted; booster; Omicron; 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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