Faculty of Medicine, Universitas Padjadjaran /Dr. Hasan Sadikin General Hospital, Bandung, Indonesia.
Faculty of Medicine, Universitas Padjadjaran /Dr. Hasan Sadikin General Hospital, Bandung, Indonesia.
Vaccine. 2021 Oct 22;39(44):6520-6528. doi: 10.1016/j.vaccine.2021.09.052. Epub 2021 Sep 24.
The WHO declared COVID-19 a pandemic on March 11th, 2020. This serious outbreak and the precipitously increasing numbers of deaths worldwide necessitated the urgent need to develop an effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. The development of COVID-19 vaccines has moved quickly. In this study, we assessed the efficacy, safety, and immunogenicity of an inactivated (SARS-CoV-2) vaccine.
We conducted a randomized, double-blind, placebo-controlled trial to evaluate the efficacy, immunogenicity, and safety of an inactivated SARS-CoV-2 vaccine and its lot-to-lot consistency. A total of 1620 healthy adults aged 18-59 years were randomly assigned to receive 2 injections of the trial vaccine or placebo on a day 0 and 14 schedule. This article was based on an interim report completed within 3 months following the last dose of study vaccine. The interim analysis includes safety and immunogenicity data for 540 participants in the immunogenicity subset and an efficacy analysis of the 1620 subjects. For the safety evaluation, solicited and unsolicited adverse events were collected after the first and second vaccination within 14 and 28 days, respectively. Blood samples were collected for an antibody assay before and 14 days following the second dose.
Most of the adverse reactions were in the solicited category and were mild in severity. Pain at the injection site was the most frequently reported symptom. Antibody IgG titer determined by enzyme-linked immunosorbent assay was 97.48% for the seroconversion rate. Using a neutralization assay, the seroconversion rate was 87.15%. The efficacy in preventing symptomatic confirmed cases of COVID-19 occurring at least 14 days after the second dose of vaccine using an incidence rate was 65.30%.
From the 3-month interim analysis, the vaccine exhibited a 65.30% efficacy at preventing COVID-19 illness with favorable safety and immunogenicity profiles.
世界卫生组织于 2020 年 3 月 11 日宣布 COVID-19 为大流行。这一严重疫情以及全球死亡人数的急剧增加，使得迫切需要开发一种有效的严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）疫苗。COVID-19 疫苗的开发进展迅速。在这项研究中，我们评估了一种灭活（SARS-CoV-2）疫苗的疗效、安全性和免疫原性。
我们进行了一项随机、双盲、安慰剂对照试验，以评估一种灭活 SARS-CoV-2 疫苗及其批间一致性的疗效、免疫原性和安全性。总共 1620 名年龄在 18-59 岁的健康成年人被随机分配在第 0 天和第 14 天接受 2 次试验疫苗或安慰剂。本文基于在研究疫苗最后一剂后 3 个月内完成的中期报告。中期分析包括免疫原性亚组的 540 名参与者的安全性和免疫原性数据，以及 1620 名受试者的疗效分析。对于安全性评估，在第一次和第二次接种后 14 天内分别收集了第一次和第二次接种后 14 天内的预期和非预期不良事件。在第二次接种后 14 天内采集血样进行抗体检测。
大多数不良反应为预期不良反应，且严重程度为轻度。注射部位疼痛是最常报告的症状。酶联免疫吸附试验测定的抗体 IgG 滴度为血清转化率的 97.48%。使用中和试验，血清转化率为 87.15%。第二次接种后至少 14 天，疫苗预防 COVID-19 症状性确诊病例的发病率为 65.30%。
从 3 个月的中期分析来看，该疫苗预防 COVID-19 疾病的疗效为 65.30%，具有良好的安全性和免疫原性。
