Abarca Katia, Iturriaga Carolina, Urzúa Marcela, Le Corre Nicole, Pineda Augusto, Fernández Carolina, Domínguez Angélica, González Pablo A, Bueno Susan M, Donato Paulina, Espinoza Pilar, Fuentes Daniela, González Marcela, Guzmán Paula, Muñoz-Venturelli Paula, Pérez Carlos M, Potin Marcela, Rojas Álvaro, González-Aramundiz José V, Gálvez Nicolás M S, Aguirre-Boza Francisca, Aljaro Sofía, Bátiz Luis Federico, Campisto Yessica, Cepeda Mariela, Cortés Aarón, López Sofía, Pérez María Loreto, Schilling Andrea, Kalergis Alexis M
Departamento de Enfermedades Infecciosas e Inmunología Pediátrica, División de Pediatría, School of Medicine, Pontificia Universidad Católica de Chile, Santiago 8330077, Chile.
Millennium Institute on Immunology and Immunotherapy, Santiago 3871336, Chile.
Vaccines (Basel). 2022 Jul 6;10(7):1082. doi: 10.3390/vaccines10071082.
Several vaccines have been developed to control the COVID-19 pandemic. CoronaVac, an inactivated SARS-CoV-2 vaccine, has demonstrated safety and immunogenicity, preventing severe COVID-19 cases. We investigate the safety and non-inferiority of two immunization schedules of CoronaVac in a non-inferiority trial in healthy adults. A total of 2302 healthy adults were enrolled at 8 centers in Chile and randomly assigned to two vaccination schedules, receiving two doses with either 14 or 28 days between each. The primary safety and efficacy endpoints were solicited adverse events (AEs) within 7 days of each dose, and comparing the number of cases of SARS-CoV-2 infection 14 days after the second dose between the schedules, respectively. The most frequent local AE was pain at the injection site, which was less frequent in participants aged ≥60 years. Other local AEs were reported in less than 5% of participants. The most frequent systemic AEs were headache, fatigue, and myalgia. Most AEs were mild and transient. There were no significant differences for local and systemic AEs between schedules. A total of 58 COVID-19 cases were confirmed, and all but 2 of them were mild. No differences were observed in the proportion of COVID-19 cases between schedules. CoronaVac is safe, especially in ≥60-year-old participants. Both schedules protected against COVID-19 hospitalization.
已经研发出几种疫苗来控制新冠疫情。科兴新冠疫苗（CoronaVac）是一种灭活的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫苗，已证明具有安全性和免疫原性，可预防重症新冠病例。我们在一项针对健康成年人的非劣效性试验中，研究了科兴新冠疫苗两种免疫程序的安全性和非劣效性。共有2302名健康成年人在智利的8个中心入组，并随机分配到两种疫苗接种程序中，每种程序接种两剂，两剂之间间隔14天或28天。主要安全性和有效性终点分别为每剂接种后7天内出现的主动报告的不良事件（AE），以及比较两种程序在第二剂接种后14天的严重急性呼吸综合征冠状病毒2感染病例数。最常见的局部不良事件是注射部位疼痛，在60岁及以上的参与者中发生率较低。其他局部不良事件在不到5%的参与者中报告。最常见的全身不良事件是头痛、疲劳和肌痛。大多数不良事件为轻度且短暂。两种程序在局部和全身不良事件方面无显著差异。共确诊58例新冠病例，其中除2例以外均为轻症。两种程序在新冠病例比例上未观察到差异。科兴新冠疫苗是安全的，尤其是在60岁及以上的参与者中。两种程序均能预防新冠住院。
