A personal COVID-19 dendritic cell vaccine made at point-of-care: Feasibility, safety, and antigen-specific cellular immune responses
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a world-wide pandemic. Internationally, because of availability, accessibility, and distribution issues, there is a need for additional vaccines. This study aimed to: establish the feasibility of personal dendritic cell vaccines...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2022-11-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2022.2100189 |
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| author | Gabriel I. Nistor Robert O. Dillman Rockelle M. Robles James L. Langford Aleksandra J. Poole Muchlis A. U. Sofro Yetty M. Nency Jonny Jonny Martina L. Yana Mahammad Karyana Endang S. Lestari Ria Triwardhani Mujahidah Mujahidah Retty K. Sari Nur A. Soetojo Djoko Wibisono Daniel Tjen Taruna Ikrar Gregory Sarkissian Haryono Winarta Terawan A. Putranto Hans S. Keirstead |
| author_facet | Gabriel I. Nistor Robert O. Dillman Rockelle M. Robles James L. Langford Aleksandra J. Poole Muchlis A. U. Sofro Yetty M. Nency Jonny Jonny Martina L. Yana Mahammad Karyana Endang S. Lestari Ria Triwardhani Mujahidah Mujahidah Retty K. Sari Nur A. Soetojo Djoko Wibisono Daniel Tjen Taruna Ikrar Gregory Sarkissian Haryono Winarta Terawan A. Putranto Hans S. Keirstead |
| author_sort | Gabriel I. Nistor |
| collection | DOAJ |
| description | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a world-wide pandemic. Internationally, because of availability, accessibility, and distribution issues, there is a need for additional vaccines. This study aimed to: establish the feasibility of personal dendritic cell vaccines to the SARS-CoV-2 spike protein, establish the safety of a single subcutaneous vaccine injection, and determine the antigen-specific immune response following vaccination. In Phase 1, 31 subjects were assigned to one of nine formulations of autologous dendritic cells and lymphocytes (DCL) incubated with 0.10, 0.33, or 1.0 µg of recombinant SARS-CoV-2 spike protein, and admixed with saline or 250 or 500 µg of granulocyte-macrophage colony-stimulating factor (GM-CSF) prior to injection, then assessed for safety and humoral response. In Phase 2, 145 subjects were randomized to one of three formulations defined by incubation with the same three quantities of spike protein without GM-CSF, then assessed for safety and cellular response. Vaccines were successfully manufactured for every subject at point-of-care. Approximately 46.4% of subjects had a grade 1 adverse event (AE); 6.5% had a grade 2 AE. Among 169 evaluable subjects, there were no acute allergic, grade 3 or 4, or serious AE. In Phase 1, anti-receptor binding domain antibodies were increased in 70% of subjects on day-28. In Phase 2, in the 127 subjects who did not have high levels of gamma interferon-producing cells at baseline, 94.4% had increased by day 14 and 96.8% by day 28. Point-of-care personal vaccine manufacturing was feasible. Further development of such subject-specific vaccines is warranted. |
| first_indexed | 2024-03-11T21:40:57Z |
| format | Article |
| id | doaj.art-b6196d24b86b44d29c270d4fa93f9657 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:40:57Z |
| publishDate | 2022-11-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-b6196d24b86b44d29c270d4fa93f96572023-09-26T13:19:08ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2022-11-0118610.1080/21645515.2022.21001892100189A personal COVID-19 dendritic cell vaccine made at point-of-care: Feasibility, safety, and antigen-specific cellular immune responsesGabriel I. Nistor0Robert O. Dillman1Rockelle M. Robles2James L. Langford3Aleksandra J. Poole4Muchlis A. U. Sofro5Yetty M. Nency6Jonny Jonny7Martina L. Yana8Mahammad KaryanaEndang S. Lestari9Ria Triwardhani10Mujahidah Mujahidah11Retty K. Sari12Nur A. Soetojo13Djoko Wibisono14Daniel Tjen15Taruna Ikrar16Gregory Sarkissian17Haryono Winarta18Terawan A. Putranto19Hans S. Keirstead20AIVITA BiomedicalAIVITA BiomedicalAIVITA BiomedicalAIVITA BiomedicalAIVITA BiomedicalDr. Kariadi HospitalDiponegoro UniversityGatot Soebroto Army Hospital (RSPAD)Gatot Soebroto Army Hospital (RSPAD)Ministry of Health Republic of IndonesiaDr. Kariadi HospitalDr. Kariadi HospitalGatot Soebroto Army Hospital (RSPAD)Dr. Kariadi HospitalGatot Soebroto Army Hospital (RSPAD)Gatot Soebroto Army Hospital (RSPAD)Ministry of Health Republic of IndonesiaPT AIVITA Biomedika IndonesiaPT Rama Emerald Multi SuksesGatot Soebroto Army Hospital (RSPAD)AIVITA BiomedicalSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a world-wide pandemic. Internationally, because of availability, accessibility, and distribution issues, there is a need for additional vaccines. This study aimed to: establish the feasibility of personal dendritic cell vaccines to the SARS-CoV-2 spike protein, establish the safety of a single subcutaneous vaccine injection, and determine the antigen-specific immune response following vaccination. In Phase 1, 31 subjects were assigned to one of nine formulations of autologous dendritic cells and lymphocytes (DCL) incubated with 0.10, 0.33, or 1.0 µg of recombinant SARS-CoV-2 spike protein, and admixed with saline or 250 or 500 µg of granulocyte-macrophage colony-stimulating factor (GM-CSF) prior to injection, then assessed for safety and humoral response. In Phase 2, 145 subjects were randomized to one of three formulations defined by incubation with the same three quantities of spike protein without GM-CSF, then assessed for safety and cellular response. Vaccines were successfully manufactured for every subject at point-of-care. Approximately 46.4% of subjects had a grade 1 adverse event (AE); 6.5% had a grade 2 AE. Among 169 evaluable subjects, there were no acute allergic, grade 3 or 4, or serious AE. In Phase 1, anti-receptor binding domain antibodies were increased in 70% of subjects on day-28. In Phase 2, in the 127 subjects who did not have high levels of gamma interferon-producing cells at baseline, 94.4% had increased by day 14 and 96.8% by day 28. Point-of-care personal vaccine manufacturing was feasible. Further development of such subject-specific vaccines is warranted.http://dx.doi.org/10.1080/21645515.2022.2100189personal vaccinesars-cov-2phase 1phase 2dendritic cells |
| spellingShingle | Gabriel I. Nistor Robert O. Dillman Rockelle M. Robles James L. Langford Aleksandra J. Poole Muchlis A. U. Sofro Yetty M. Nency Jonny Jonny Martina L. Yana Mahammad Karyana Endang S. Lestari Ria Triwardhani Mujahidah Mujahidah Retty K. Sari Nur A. Soetojo Djoko Wibisono Daniel Tjen Taruna Ikrar Gregory Sarkissian Haryono Winarta Terawan A. Putranto Hans S. Keirstead A personal COVID-19 dendritic cell vaccine made at point-of-care: Feasibility, safety, and antigen-specific cellular immune responses Human Vaccines & Immunotherapeutics personal vaccine sars-cov-2 phase 1 phase 2 dendritic cells |
| title | A personal COVID-19 dendritic cell vaccine made at point-of-care: Feasibility, safety, and antigen-specific cellular immune responses |
| title_full | A personal COVID-19 dendritic cell vaccine made at point-of-care: Feasibility, safety, and antigen-specific cellular immune responses |
| title_fullStr | A personal COVID-19 dendritic cell vaccine made at point-of-care: Feasibility, safety, and antigen-specific cellular immune responses |
| title_full_unstemmed | A personal COVID-19 dendritic cell vaccine made at point-of-care: Feasibility, safety, and antigen-specific cellular immune responses |
| title_short | A personal COVID-19 dendritic cell vaccine made at point-of-care: Feasibility, safety, and antigen-specific cellular immune responses |
| title_sort | personal covid 19 dendritic cell vaccine made at point of care feasibility safety and antigen specific cellular immune responses |
| topic | personal vaccine sars-cov-2 phase 1 phase 2 dendritic cells |
| url | http://dx.doi.org/10.1080/21645515.2022.2100189 |
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