与 Comirnaty® 相比，ZR-202-CoV 和 ZR-202a-CoV 重组疫苗的安全性、反应原性和免疫原性：一项随机、观察者盲法对照的 1 期研究。

IF 4.8 2区医学 Q1 INFECTIOUS DISEASES

International Journal of Infectious Diseases Pub Date : 2024-09-11 DOI:10.1016/j.ijid.2024.107237

Samba O. Sow , Milagritos D. Tapia , Fadima C. Haidara , Fatoumata Diallo , Xi Han , Jingjing Chen , Lei Shi , Qing Yang , Bangwei Yu , Yalin Hu , Lin Yuan , Ge Liu , Silvia Grappi , Martina Monti , Simonetta Viviani , Min Ji , Chenliang Zhou

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引用次数: 0

摘要

目的：ZR-202-CoV 和 ZR-202a-CoV 是新型重组疫苗，分别含有 25 µg 在 CHO 细胞中表达的原型（武汉株）或 B.1.351 株（Beta 变种）SARS-CoV-2 S 蛋白，并添加了 Al(OH)3 和 CpG-ODN 佐剂。我们在马里进行的这项一期随机、观察盲法对照研究中评估了它们的安全性和免疫原性：设计：60 名 18-55 岁的健康成年人按 1:1:1 的比例随机接受两剂 ZR-202-CoV、ZR-202a-CoV 或 Comirnaty® ，每剂相隔 28 天。主要结果指标为主动和非主动不良事件（AEs），包括AESI（特别关注不良事件）；次要结果指标为免疫原性，即SARS-CoV-2特异性中和抗体。对参与者进行了为期一年的随访：结果：注射部位疼痛和头痛分别是最常见的局部和全身不良反应。在研究期间，没有报告与疫苗接种相关的主动性AE或SAE。虽然大多数参与者在基线时就能检测到中和抗体，但在接种第一剂疫苗后，所有疫苗组都观察到了强大的免疫反应，第二剂疫苗接种后免疫反应没有进一步增强。ZR-202-CoV、ZR-202a-CoV 和 Comirnaty® 对 Beta、Delta 和 Omicron BA.5 变体的交叉中和抗体反应程度相似：结论：ZR-202-CoV、ZR-202a-CoV 和 Comirnaty® 具有相似的反应原性和免疫原性特征，支持在更广泛的人群中开展进一步的临床研究。

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Safety, reactogenicity, and immunogenicity of ZR-202-CoV and ZR-202a-CoV recombinant vaccines compared with ComirnatyⓇ: A randomized, observer-blind, controlled, phase 1 study

Objectives

ZR-202-CoV and ZR-202a-CoV are novel recombinant vaccines containing 25 µg of the prototype (Wuhan strain) or B.1.351 strain (Beta variant) SARS-CoV-2 S-protein expressed in CHO cells, respectively, adjuvanted with Al(OH)₃ and CpG-ODN. We assessed their safety and immunogenicity in this Phase I, randomized, observer-blind, controlled study in Mali.

Design

Sixty healthy 18–55-year-old adults randomized 1:1:1 received two doses of ZR-202-CoV, ZR-202a-CoV, or Comirnaty^Ⓡ 28 days apart. Primary outcome measures were solicited and unsolicited adverse events (AEs) including AESI (Adverse Events of Special Interest); secondary outcome was immunogenicity measured as SARS-CoV-2 specific neutralizing antibodies. Participants were followed up for 1 year.

Results

Injection site pain and headache were the most frequent solicited local and systemic AEs, respectively. No unsolicited AEs or SAEs related to vaccination were reported during the study period. Although most participants had detectable neutralizing antibodies at baseline robust immune responses were observed in all vaccine groups after the first dose with no further increase after the second dose. Cross-neutralizing antibody responses against Beta, Delta, and Omicron BA.5 variants were similar in magnitude after ZR-202-CoV, ZR-202a-CoV and Comirnaty^Ⓡ.

Conclusions

Similar reactogenicity and immunogenicity profiles of ZR-202-CoV, ZR-202a-CoV and Comirnaty^Ⓡ support further clinical investigation in a wider population.

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来源期刊

International Journal of Infectious Diseases 医学-传染病学

CiteScore

18.90

自引率

2.40%

发文量

1020

审稿时长

30 days

期刊介绍： International Journal of Infectious Diseases (IJID) Publisher: International Society for Infectious Diseases Publication Frequency: Monthly Type: Peer-reviewed, Open Access Scope: Publishes original clinical and laboratory-based research. Reports clinical trials, reviews, and some case reports. Focuses on epidemiology, clinical diagnosis, treatment, and control of infectious diseases. Emphasizes diseases common in under-resourced countries.