Clinical Tuberculosis and Epidemiology Research Centre, National Research Institute for Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Medical Department, Orchid Pharmed Company, Tehran, Iran.
Clin Microbiol Infect. 2022 Sep;28(9):1263-1271. doi: 10.1016/j.cmi.2022.04.004. Epub 2022 Apr 15.
We aimed to investigate the immunogenicity and safety of SpikoGen®, a subunit COVID-19 vaccine composed of a recombinant prefusion-stabilized SARS-CoV-2 spike protein combined with the Advax-CpG55.2™ adjuvant, in seronegative and seropositive populations as primary vaccination.
This randomized, placebo-controlled, double-blind phase 2 trial was conducted on 400 participants randomized 3:1 to receive two doses of 25 μg of SpikoGen® 3 weeks apart or the placebo. The primary safety outcomes were the incidence of solicited adverse events up to 7 days after each dose and unsolicited adverse events up to 28 days after the second dose. The primary immunogenicity outcomes were seroconversion against the S protein and the geometric mean concentration of S antibodies by days 21 and 35.
The SpikoGen® vaccine was well tolerated and no serious adverse events were recorded. The most common solicited adverse events were injection site pain and fatigue, largely graded as mild and transient. By day 35 (2 weeks post second dose), the seroconversion rate against S was 63.55 (95% CI: 57.81-69.01) in the SpikoGen® group versus 7.23 (95% CI: 2.7-15.07) in the placebo group. The geometric mean concentration of S antibodies was 29.12 (95% CI: 24.32-34.87) in the SpikoGen® group versus 5.53 (95% CI: 4.39-6.97) in the placebo group. Previously infected seropositive volunteers showed a large SARS-CoV-2 humoral response after a single SpikoGen® dose.
SpikoGen® had an acceptable safety profile and induced promising humoral and cellular immune responses against SARS-CoV-2.
我们旨在研究 SpikoGen®作为初级疫苗接种在血清阴性和血清阳性人群中的免疫原性和安全性，SpikoGen®是一种由重组预融合稳定的 SARS-CoV-2 刺突蛋白与 Advax-CpG55.2™佐剂组成的亚单位 COVID-19 疫苗。
这是一项随机、安慰剂对照、双盲的 2 期临床试验，共纳入 400 名参与者，随机分为 3:1 组，分别接受 25μg SpikoGen®的两剂，间隔 3 周，或安慰剂。主要安全性结局是每剂后 7 天内发生的不良事件和第 2 剂后 28 天内发生的不良事件。主要免疫原性结局是血清 S 蛋白和 S 抗体的几何平均浓度在第 21 天和第 35 天的转化率。
SpikoGen®疫苗耐受性良好，未记录到严重不良事件。最常见的不良事件是注射部位疼痛和疲劳，主要为轻度和短暂。到第 35 天（第 2 剂后 2 周），SpikoGen®组对 S 的血清转化率为 63.55（95%CI：57.81-69.01），安慰剂组为 7.23（95%CI：2.7-15.07）。SpikoGen®组 S 抗体的几何平均浓度为 29.12（95%CI：24.32-34.87），安慰剂组为 5.53（95%CI：4.39-6.97）。既往感染的血清阳性志愿者在单次接受 SpikoGen®后产生了强烈的 SARS-CoV-2 体液反应。
SpikoGen®具有可接受的安全性特征，并诱导了针对 SARS-CoV-2 的有希望的体液和细胞免疫反应。
