Safety and immunogenicity of the SARS-CoV-2 LYB001 RBD-based VLP vaccine (CHO cell) phase 1 in Chinese adults: a randomized, double-blind, positive-parallel-controlled study.

IF 5.5 3区医学 Q1 IMMUNOLOGY

Expert Review of Vaccines Pub Date : 2024-01-01 Epub Date: 2024-05-02 DOI:10.1080/14760584.2024.2337051

Rong Tang, Ying Zeng, Yu Zhou, Qi Liang, Wei Kang, Zhonghua Yang, Xiaoxiang Zheng, Xia Zang, Hongxing Pan, Jing Jin, Fengcai Zhu

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引用次数: 0

Abstract

Background: Vaccination remains the cornerstone of defense against COVID-19 globally. This study aims to assess the safety and immunogenicity profile of innovative vaccines LYB001.

Research design and methods: This was a randomized, double-blind, parallel-controlled trial, in 100 healthy Chinese adults (21 to 72 years old). Three doses of 30 or 60 µg of SARS-CoV-2 RBD-based VLP vaccine (LYB001), or the SARS-CoV-2 RBD-based protein subunit vaccine (ZF2001, control group) were administered with a 28-day interval. Differences in the incidence of adverse events (AEs) and indicators of humoral and cellular immunity among the different groups were measured.

Results: No severe adverse events were confirmed to be vaccine-related, and there was no significant difference in the rate of adverse events between the LYB001 and control group or the age subgroups (p > 0.05). The LYB001 groups had significantly higher or comparable levels of seroconversion rates, neutralization antibody, S protein-binding antibody, and cellular immunity after whole vaccination than the control group.

Conclusions: Our findings support that LYB001 developed on the VLP platform is safe and well tolerated with favorable immunogenicity for fundamental vaccination in healthy adults. Therefore, further larger-scale clinical studies are warranted.

Trial registration: This trial was registered with ClinicalTrials.gov (NCT05552573).

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中国成年人接种基于 LYB001 RBD 的 SARS-CoV-2 VLP 疫苗（CHO 细胞）第一阶段的安全性和免疫原性：随机、双盲、阳性平行对照研究。

背景：疫苗接种仍是全球防御 COVID-19 的基石。本研究旨在评估创新疫苗 LYB001 的安全性和免疫原性：这是一项随机、双盲、平行对照试验，对象为 100 名健康的中国成年人（21 至 72 岁）。试验采用随机、双盲、平行对照的方法，给 100 名健康的中国成年人（21 至 72 岁）接种了三剂 30 或 60 µg 的基于 SARS-CoV-2 RBD 的 VLP 疫苗（LYB001），或基于 SARS-CoV-2 RBD 的蛋白亚单位疫苗（ZF2001，对照组），每剂间隔 28 天。测量了不同组间不良事件（AEs）发生率以及体液免疫和细胞免疫指标的差异：结果：没有严重不良事件被证实与疫苗有关，LYB001组与对照组或各年龄亚组之间的不良事件发生率没有显著差异（P > 0.05）。LYB001组在全程接种后的血清转换率、中和抗体、S蛋白结合抗体和细胞免疫水平明显高于对照组，或与之相当：我们的研究结果表明，基于 VLP 平台开发的 LYB001 安全、耐受性好、免疫原性良好，可用于健康成人的基础疫苗接种。因此，有必要进一步开展更大规模的临床研究：本试验已在 ClinicalTrials.gov (NCT05552573) 注册。

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

Expert Review of Vaccines 医学-免疫学

CiteScore

9.10

自引率

3.20%

发文量

136

审稿时长

4-8 weeks

期刊介绍： Expert Review of Vaccines (ISSN 1476-0584) provides expert commentary on the development, application, and clinical effectiveness of new vaccines. Coverage includes vaccine technology, vaccine adjuvants, prophylactic vaccines, therapeutic vaccines, AIDS vaccines and vaccines for defence against bioterrorism. All articles are subject to rigorous peer-review. The vaccine field has been transformed by recent technological advances, but there remain many challenges in the delivery of cost-effective, safe vaccines. Expert Review of Vaccines facilitates decision making to drive forward this exciting field.