在智利的一组健康成年人中使用灭活的严重急性呼吸综合征冠状病毒 2 疫苗的安全性和免疫原性。
Safety and Immunogenicity of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in a Subgroup of Healthy Adults in Chile.
机构信息
Millennium Institute on Immunology and Immunotherapy, Santiago, Chile.
Departamento de Genética Molecular y Microbiología, Facultad de Ciencias Biológicas, Pontificia Universidad Católica de Chile, Santiago, Chile.
出版信息
Clin Infect Dis. 2022 Aug 24;75(1):e792-e804. doi: 10.1093/cid/ciab823.
BACKGROUND
The development of effective vaccines against coronavirus disease 2019 is a global priority. CoronaVac is an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine with promising safety and immunogenicity profiles. This article reports safety and immunogenicity results obtained for healthy Chilean adults aged ≥18 years in a phase 3 clinical trial.
METHODS
Volunteers randomly received 2 doses of CoronaVac or placebo, separated by 2 weeks. A total of 434 volunteers were enrolled, 397 aged 18-59 years and 37 aged ≥60 years. Solicited and unsolicited adverse reactions were registered from all volunteers. Blood samples were obtained from a subset of volunteers and analyzed for humoral and cellular measures of immunogenicity.
RESULTS
The primary adverse reaction in the 434 volunteers was pain at the injection site, with a higher incidence in the vaccine than in the placebo arm. Adverse reactions observed were mostly mild and local. No severe adverse events were reported. The humoral evaluation was performed on 81 volunteers. Seroconversion rates for specific anti-S1-receptor binding domain (RBD) immunoglobulin G (IgG) were 82.22% and 84.44% in the 18-59 year age group and 62.69% and 70.37% in the ≥60 year age group, 2 and 4 weeks after the second dose, respectively. A significant increase in circulating neutralizing antibodies was detected 2 and 4 weeks after the second dose. The cellular evaluation was performed on 47 volunteers. We detected a significant induction of T-cell responses characterized by the secretion of interferon-γ (IFN-γ) upon stimulation with Mega Pools of peptides from SARS-CoV-2.
CONCLUSIONS
Immunization with CoronaVac in a 0-14 schedule in Chilean adults aged ≥18 years is safe, induces anti-S1-RBD IgG with neutralizing capacity, activates T cells, and promotes the secretion of IFN-γ upon stimulation with SARS-CoV-2 antigens.
背景
开发针对 2019 年冠状病毒病（COVID-19）的有效疫苗是全球的当务之急。科兴中维的新型冠状病毒灭活疫苗（CoronaVac）具有良好的安全性和免疫原性。本文报告了在智利进行的一项 3 期临床试验中，健康成年人（年龄≥18 岁）接种该疫苗的安全性和免疫原性结果。
方法
志愿者随机接受 2 剂科兴中维或安慰剂，间隔 2 周。共纳入 434 名志愿者，397 名年龄 18-59 岁，37 名年龄≥60 岁。所有志愿者均报告了主动和被动不良反应。采集部分志愿者的血样，分析体液和细胞免疫指标。
结果
434 名志愿者的主要不良反应为注射部位疼痛，疫苗组高于安慰剂组。观察到的不良反应大多为轻度和局部反应。未报告严重不良事件。对 81 名志愿者进行了体液评估。第 18-59 岁年龄组和第≥60 岁年龄组志愿者在第 2 剂后 2 周和 4 周时，特异性抗 SARS-CoV-2 受体结合域（RBD）免疫球蛋白 G（IgG）的血清转化率分别为 82.22%和 84.44%，62.69%和 70.37%。第 2 剂后 2 周和 4 周，均可检测到循环中和抗体显著增加。对 47 名志愿者进行了细胞评估。我们检测到 T 细胞反应显著诱导，表现在经 SARS-CoV-2 肽 Mega Pools 刺激后分泌干扰素-γ（IFN-γ）。
结论
在智利≥18 岁成年人中，0-14 天免疫程序接种科兴中维疫苗安全，诱导产生具有中和能力的抗 S1-RBD IgG，激活 T 细胞，并在刺激 SARS-CoV-2 抗原时促进 IFN-γ分泌。
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