Significant improvement of systemic lupus erythematosus manifestation in children after autologous dendritic cell transfer: a case report and review of literature.

Dendritic cells (DC) are postulated to play a role in autoimmune diseases such as Systemic Lupus Erythematosus (SLE). We reported a 13-year-old female SLE patient who presents with chronic arthritis accompanied by persistent fever, dyspnea, sleep disturbance, headache, stomatitis, rash, and muscle weakness. The supporting examinations showed abnormal blood cell counts, positive antinuclear antibody profile, serositis, and neuropathy. Immunosuppressants failed to improve the condition. DC-based vaccine derived from autologous peripheral blood which was introduced with SARS-CoV-2 protein was given to this patient. There was a significant improvement in clinical and laboratory findings. Thus, DC immunotherapy appears to be a potential novel therapy for SLE that needs to be studied.

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

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.