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

Frontiers in Immunology

Immunology

Endang Sri Lestari¹  Retty Karisma Sari¹  Ria Triwardhani¹  Nur Alaydrus Soetojo¹  Muchlis Achsan Udji Sofro¹  Yetty Movieta Nency¹  Terawan Agus Putranto²  Enda Cindylosa Sitepu²  Raoulian Irfon²  Bunga Pinandhita Ramadhani²  Martina Lily Yana²  Jonny Jonny³ 

[1] Dr. Kariadi Hospital/Faculty of Medicine, Diponegoro University, Semarang, Indonesia;Installation of Cellcure Development, Gatot Soebroto Central Army Hospital, Jakarta, Indonesia;Installation of Cellcure Development, Gatot Soebroto Central Army Hospital, Jakarta, Indonesia;Faculty of Medicine University of Pembangunan Nasional “Veteran” Jakarta, Jakarta, Indonesia;

关键词: COVID-19;    vaccine;    dendritic cells;    SARS-CoV-2;    clinical trial;    autologous vaccines;   

DOI  :  10.3389/fimmu.2023.1122389

 received in 2022-12-12, accepted in 2023-05-24,  发布年份 2023

来源: Frontiers

【 摘 要 】

IntroductionInterim 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.MethodsAdult 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.ResultsA 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.ConclusionsAfter 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.

【 授权许可】

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Copyright © 2023 Jonny, Putranto, Yana, Sitepu, Irfon, Ramadhani, Sofro, Nency, Lestari, Triwardhani, Mujahidah, Sari and Soetojo