Installation of Cellcure Development, Gatot Soebroto Central Army Hospital, Jakarta, Indonesia.
Faculty of Medicine University of Pembangunan Nasional "Veteran" Jakarta, Jakarta, Indonesia.
Front Immunol. 2023 Jun 19;14:1122389. doi: 10.3389/fimmu.2023.1122389. eCollection 2023.
Interim analysis of phase I and phase II clinical trials of personalized vaccines made from autologous monocyte-derived dendritic cells (DCs) incubated with S-protein of SARS-CoV-2 show that this vaccine is safe and well tolerated. Our previous report also indicates that this vaccine can induce specific T-cell and B cell responses against SARS-CoV-2. Herein, we report the final analysis after 1 year of follow-up regarding its safety and efficacy in subjects of phase I and phase II clinical trials.
Adult subjects (>18 years old) were given autologous DCs derived from peripheral blood monocytes, which were incubated with the S-protein of SARS-CoV-2. The primary outcome is safety in phase I clinical trials. Meanwhile, optimal antigen dosage is determined in phase II clinical trials. Corona Virus Disease 2019 (COVID-19) and Non-COVID-19 adverse events (AEs) were observed for 1 year.
A total of 28 subjects in the phase I clinical trial were randomly assigned to nine groups based on antigen and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) dosage. In the phase II clinical trial, 145 subjects were randomly grouped into three groups based on antigen dosage. During the 1-year follow-up period, 35.71% of subjects in phase I and 16.54% in phase II had non-COVID AEs. No subjects in phase I experienced moderate-severe COVID-19. Meanwhile, 4.31% of subjects in phase II had moderate-severe COVID-19. There is no difference in both COVID and non-COVID-19 AEs between groups.
After 1 year of follow-up, this vaccine is proven safe and effective for preventing COVID-19. A phase III clinical trial involving more subjects should be conducted to establish its efficacy and see other possible side effects.
对使用自体单核细胞来源的树突状细胞（DC）与 SARS-CoV-2 的 S 蛋白孵育制成的个体化疫苗进行的 I 期和 II 期临床试验的中期分析表明，该疫苗安全且耐受良好。我们之前的报告还表明，该疫苗可诱导针对 SARS-CoV-2 的特异性 T 细胞和 B 细胞反应。在此，我们报告了 I 期和 II 期临床试验中 1 年随访时该疫苗的安全性和有效性的最终分析结果。
给予成年受试者（>18 岁）源自外周血单核细胞的自体 DC，其与 SARS-CoV-2 的 S 蛋白孵育。I 期临床试验的主要结局为安全性。同时，在 II 期临床试验中确定最佳抗原剂量。观察 1 年期间的 COVID-19 和非 COVID-19 不良事件（AE）。
I 期临床试验共纳入 28 例受试者，根据抗原和粒细胞-巨噬细胞集落刺激因子（GM-CSF）剂量随机分为 9 组。在 II 期临床试验中，145 例受试者根据抗原剂量随机分为 3 组。在 1 年随访期间，I 期的 35.71%和 II 期的 16.54%的受试者出现非 COVID-AE。I 期无受试者发生中重度 COVID-19。同时，II 期有 4.31%的受试者发生中重度 COVID-19。各组间 COVID 和非 COVID-AE 无差异。
随访 1 年后，该疫苗可安全有效地预防 COVID-19。应进行涉及更多受试者的 III 期临床试验，以确定其疗效和观察其他可能的副作用。
