背景：SARS-CoV-2引起的COVID-19对公众健康构成巨大威胁。我们提供了mRNA疫苗（LVRNA009）在中国的I期试验的安全性和免疫原性数据。
方法：在单中心，双盲,安慰剂对照和剂量递增研究，72名年龄在18-59岁的健康未接种疫苗的成年人被随机（3：1）接受LVRNA009和三种疫苗剂量之一（25、50和100μg）或安慰剂，为了评估安全性，LVRNA009的耐受性和免疫原性。
结果：所有这些参与者都间隔28天接受了两次注射。在研究期间没有报告高于2级的不良事件。共有30名参与者（42％）在接种疫苗后的前14天内报告了征求的不良反应。在报告的事件中，发热（n=11，15%）是最常见的全身不良反应，注射部位疼痛(n=17,24%)是最常见的局部不良反应.观察到抗S蛋白IgG和中和抗体在第一次给药后14天被诱导，第二次给药后7天显着增加，并在第二次给药后28天保持在高水平。特异性T细胞应答在第二次疫苗接种后7天达到峰值并持续28天。
结论：LVRNA009在中国成年人中在所有三种剂量水平的安全性和耐受性方面都显示出了有希望的结果。LVRNA009在三个剂量水平可以迅速诱导强烈的体液和细胞免疫反应，包括结合和中和抗体的产生和IFN-γ的分泌，表现出良好的免疫原性。
背景：Clinicaltrials.govNCT05364047;Chictr.org.cnChiCTR2100049349。
COVID-19 caused by SARS-CoV-2 is a great threat to public health. We present the safety and immunogenicity data from a phase I trial in
China of an mRNA vaccine (LVRNA009).
In the single-centre, double-blind, placebo-controlled and dose-escalation study, 72 healthy unvaccinated adults aged 18-59 years were randomized (3:1) to receive LVRNA009 with one of three vaccine dosage (25, 50 and 100 μg) or placebo, to evaluate for the safety, tolerability and immunogenicity of LVRNA009.
All these participants received two injections 28 days apart. No adverse events higher than grade 2 were reported during the study. A total of 30 participants (42 %) reported solicited adverse reactions during the first 14 days after vaccinations. Of the events reported, fever (n = 11, 15 %) was the most common systemic adverse reaction, and pain at the injection site (n = 17, 24 %) was the most frequent solicited local adverse reaction. Anti-S-protein IgG and neutralising antibodies were observed to have been induced 14 days after the first dose, significantly increased 7 days after the second dose, and remained at a high level 28 days after the second dose. Specific T-cell responses peaked 7 days and persisted 28 days after second vaccination.
LVRNA009 has demonstrated promising results in safety and tolerability at all three dose levels among Chinese adults. LVRNA009 at three dose levels could rapidly induce strong humoral and cellular immune responses, including binding and neutralising antibody production and IFN- γ secretion, which showed good immunogenicity.
Clinicaltrials.gov NCT05364047; Chictr.org.cn ChiCTR2100049349.
