文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

COVID-19 预防用树突状细胞疫苗的安全性和有效性:1 年随访的 I 期和 II 期临床试验最终结果。

Safety and efficacy of dendritic cell vaccine for COVID-19 prevention after 1-Year follow-up: phase I and II clinical trial final result.

机构信息

Installation of Cellcure Development, Gatot Soebroto Central Army Hospital, Jakarta, Indonesia.

Faculty of Medicine University of Pembangunan Nasional "Veteran" Jakarta, Jakarta, Indonesia.

出版信息

Front Immunol. 2023 Jun 19;14:1122389. doi: 10.3389/fimmu.2023.1122389. eCollection 2023.


DOI:10.3389/fimmu.2023.1122389
PMID:37404828
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10315914/
Abstract

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

摘要

简介: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。

方法: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)。

结果: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。

结论: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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d03c/10315914/79abcefdb629/fimmu-14-1122389-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d03c/10315914/77b0bdd62ff6/fimmu-14-1122389-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d03c/10315914/79abcefdb629/fimmu-14-1122389-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d03c/10315914/77b0bdd62ff6/fimmu-14-1122389-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d03c/10315914/79abcefdb629/fimmu-14-1122389-g002.jpg

相似文献

[1]
Safety and efficacy of dendritic cell vaccine for COVID-19 prevention after 1-Year follow-up: phase I and II clinical trial final result.

Front Immunol. 2023

[2]
A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial.

Trials. 2021-4-13

[3]
Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials.

Lancet Infect Dis. 2021-8

[4]
A personal COVID-19 dendritic cell vaccine made at point-of-care: Feasibility, safety, and antigen-specific cellular immune responses.

Hum Vaccin Immunother. 2022-11-30

[5]
Safety and immunogenicity of an inactivated whole virion SARS-CoV-2 vaccine, TURKOVAC, in healthy adults: Interim results from randomised, double-blind, placebo-controlled phase 1 and 2 trials.

Vaccine. 2023-1-9

[6]
Safety and immunogenicity of a protein subunit COVID-19 vaccine (ZF2001) in healthy children and adolescents aged 3-17 years in China: a randomised, double-blind, placebo-controlled, phase 1 trial and an open-label, non-randomised, non-inferiority, phase 2 trial.

Lancet Child Adolesc Health. 2023-4

[7]
The Rapid Development and Early Success of Covid 19 Vaccines Have Raised Hopes for Accelerating the Cancer Treatment Mechanism.

Arch Razi Inst. 2021-3

[8]
Safety and immunogenicity of a live-attenuated influenza virus vector-based intranasal SARS-CoV-2 vaccine in adults: randomised, double-blind, placebo-controlled, phase 1 and 2 trials.

Lancet Respir Med. 2022-8

[9]
Final efficacy analysis, interim safety analysis, and immunogenicity of a single dose of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomised, double-blinded, placebo-controlled phase 3 trial.

Lancet. 2022-1-15

[10]
Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial.

Lancet Microbe. 2022-3

引用本文的文献

[1]
Cardiovascular adverse effects of immunotherapy in cancer: insights and implications.

Front Oncol. 2025-6-18

[2]
The Effect of Autologous Dendritic Cell Immunotherapy on Kidney Function and Endothelial Dysfunction of Patients with Diabetic Kidney Disease (DKD): An Open Label Clinical Trial.

Curr Issues Mol Biol. 2025-1-6

[3]
Clinical Trial: Effect of Autologous Dendritic Cell Administration on Improving Neuropathy Symptoms and Inflammatory Biomarkers in Diabetic Neuropathy.

Curr Issues Mol Biol. 2024-12-20

本文引用的文献

[1]
Developing dendritic cell for SARS-CoV-2 vaccine: Breakthrough in the pandemic.

Front Immunol. 2022

[2]
A personal COVID-19 dendritic cell vaccine made at point-of-care: Feasibility, safety, and antigen-specific cellular immune responses.

Hum Vaccin Immunother. 2022-11-30

[3]
Second-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland.

Nat Commun. 2022-8-15

[4]
SARS-CoV-2 epitope-specific CD4 memory T cell responses across COVID-19 disease severity and antibody durability.

Sci Immunol. 2022-7-22

[5]
Revisiting COVID-19 vaccine hesitancy around the world using data from 23 countries in 2021.

Nat Commun. 2022-7-1

[6]
Surveillance of Post-Vaccination Side Effects of COVID-19 Vaccines among Saudi Population: A Real-World Estimation of Safety Profile.

Vaccines (Basel). 2022-6-10

[7]
A Paradigm Shift in the Combination Changes of SARS-CoV-2 Variants and Increased Spread of Delta Variant (B.1.617.2) across the World.

Aging Dis. 2022-6-1

[8]
Dendritic cell vaccine as a potential strategy to end the COVID-19 pandemic. Why should it be ?

Expert Rev Vaccines. 2022-8

[9]
Efficacy and Safety of the RBD-Dimer-Based Covid-19 Vaccine ZF2001 in Adults.

N Engl J Med. 2022-6-2

[10]
Risk of severe illness in patients infected with SARS-CoV-2 of Delta variant: a systematic review and meta-analysis.

Infect Dis (Lond). 2022-8

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索