The Platform Trial In COVID-19 priming and BOOsting (PICOBOO): The immunogenicity, reactogenicity, and safety of licensed COVID-19 vaccinations administered as a second booster in BNT162b2 primed individuals aged 18-<50 and 50-<70 years old

IF 14.3 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection Pub Date : 2024-12-01 DOI:10.1016/j.jinf.2024.106346

C. McLeod , M. Dymock , KL Flanagan , M. Plebanski , HS Marshall , MJ Estcourt , U. Wadia , MC Tjiam , CC Blyth , K. Subbarao , FL Mordant , S. Nicholson , N. Cain , R. Brizuela , SN Faust , RB Thornton , Z. Ellis , A. Mckenzie , JA Marsh , TL Snelling , PC Richmond

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引用次数: 0

Abstract

Objectives

PICOBOO is a randomised, adaptive trial evaluating the immunogenicity, reactogenicity, and safety of COVID-19 booster strategies. Here, we present data for second boosters among individuals aged 18-<50 and 50-<70 years old primed with BNT162b2 until Day (D) 84.

Methods

Immunocompetent adults who had received two doses of BNT162b2 and any licensed COVID-19 booster at least three months prior were eligible. Participants were randomly allocated to BNT162b2, mRNA-1273 or NVX-CoV2373 1:1:1. The log₁₀ concentration of anti-spike Ig Total was summarised as the geometric mean concentration (GMC). Reactogenicity and safety outcomes were captured.

Results

Between Mar 2022 and Aug 2023, 743 participants were recruited to the trial and had D28 samples available. Of these, 120 and 103 belonged to the 18-<50 y and 50-<70 y strata, respectively. The mean adjusted GMCs (95% credible intervals) peaked at D28; these were 41 262 (31 611, 51 105), 45 585 (34 194, 57 441) and 25 281 (20 021, 31 234) U/mL in the 18-<50 y stratum and 30 753 (25 071, 36 704), 35 132 (27 523, 42 239) and 17 322 (13 983, 20 641) U/mL in the 50-<70 y stratum following BNT162b2, mRNA-1273 and NVX-CoV2373, respectively. Limited neutralisation against Omicron subvariants was found following boosting with all vaccines. There were 4 possibly or probably-related adverse events in the 18-<50 y stratum and 5 events in the 50-<70 y stratum, and severe reactogenicity events were <10% and <11% in these strata, respectively.

Conclusions

Vaccines targeting Ancestral virus elicited boosted antibody responses to Ancestral virus but minimal neutralising antibody against Omicron variants.

查看原文本刊更多论文

COVID-19 接种和加强接种平台试验（PICOBOO）：对 18-<50 岁和 50-<70 岁的 BNT162b2 接种者进行 COVID-19 疫苗接种作为第二次加强接种的免疫原性、反应原性和安全性试验。

试验目的PICOBOO 是一项随机适应性试验，旨在评估 COVID-19 强化策略的免疫原性、反应原性和安全性。在此，我们收集了 18 岁以下人群第二次加强免疫的数据：至少在三个月前接受过两剂 BNT162b2 和任何获得许可的 COVID-19 强化剂的免疫功能正常的成年人均符合条件。参与者按 1:1:1 的比例随机分配到 BNT162b2、mRNA-1273 或 NVX-CoV2373。抗尖峰抗体 Ig 总浓度的 log10 值汇总为几何平均浓度 (GMC)。研究还采集了反应生成性和安全性结果：2022 年 3 月至 2023 年 8 月期间，743 名试验参与者获得了 D28 样本。其中120人和103人属于18-结论：针对祖先病毒的疫苗可增强对祖先病毒的抗体反应，但对奥米克隆变体的中和抗体反应却微乎其微。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.