Safety and immunogenicity of Omicron protein vaccines in mRNA-vaccinated adolescents: A phase 3, randomised trial

IF 14.3 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection Pub Date : 2025-02-01 DOI:10.1016/j.jinf.2025.106428

Chijioke Bennett , Gordon Chau , Erika Clayton , Laurence Chu , Jacqueline Alvarez , Ausberto B. Hidalgo , Khozema Palanpurwala , Joyce S. Plested , Mingzhu Zhu , Shane Cloney-Clark , Zhaohui Cai , Raj Kalkeri , Karim Hegazy , Katherine Smith , Susan Neal , Fernando Noriega , Raburn M. Mallory , Jeffrey M. Adelglass , on behalf of the 2019nCoV-314 Study Investigators

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引用次数: 0

Abstract

Objectives

Safety and immunogenicity assessment of updated monovalent and bivalent SARS-CoV-2 vaccines in adolescents.

Methods

This phase 3, double-blinded study randomised 12–<18-year-old participants, who received ≥2 prior doses of an approved/authorised mRNA-based COVID-19 vaccine, 1:1 to receive NVX-CoV2601 (XBB.1.5) or a bivalent vaccine (NVX-CoV2373 [Wuhan] + NVX-CoV2601). The primary immunogenicity endpoint was day-28 neutralising antibody (nAb) geometric mean titres (GMTs) against XBB.1.5. Safety endpoints were solicited reactogenicity ≤7 days and unsolicited adverse events (AEs) ≤28 days post-vaccination and frequency/severity of predefined AEs of special interest through day 180.

Results

Of 401 randomised participants, nAb GMTs against XBB.1.5 increased (GMFR [95% CI]) for both NVX-CoV2601 (12.2 [9.5–15.5]) and the bivalent vaccine (8.4 [6.8–10.3]); post-vaccination responses to ancestral SARS-CoV-2 and the JN.1 variant were also observed. Increases in anti-spike IgG levels were comparable between the groups. Solicited and unsolicited AEs were mild to moderate, with similar occurrence among the groups. Severe and serious events were rare and unrelated to the study vaccines; no PIMMCs or myocarditis/pericarditis were reported.

Conclusions

NVX-CoV2601 elicited more robust antibody responses to XBB.1.5 and ancestral virus, compared with a bivalent formulation. The safety profile within each group was consistent with NVX-CoV2373, which contains ancestral recombinant spike protein.

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来源期刊

Journal of Infection 医学-传染病学

CiteScore

45.90

自引率

3.20%

发文量

475

审稿时长

16 days

期刊介绍： The Journal of Infection publishes original papers on all aspects of infection - clinical, microbiological and epidemiological. The Journal seeks to bring together knowledge from all specialties involved in infection research and clinical practice, and present the best work in the ever-changing field of infection. Each issue brings you Editorials that describe current or controversial topics of interest, high quality Reviews to keep you in touch with the latest developments in specific fields of interest, an Epidemiology section reporting studies in the hospital and the general community, and a lively correspondence section.