Immunogenicity and safety of a COVID-19 DNA vaccine in healthy adults and elderly: A randomized, observer-blind, placebo-controlled phase 2 trial
INO-4800 represents a DNA-based vaccine encoding the spike protein of SARS-CoV-2. This phase 2 trial evaluated the immunogenicity and safety of INO-4800 as a primary vaccination series in adults. We conducted a randomized, observer-blind, placebo-controlled phase 2 trial of intradermal injection of...
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Taylor & Francis Group
2025-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2448405 |
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| author | Siyue Jia Chengwei Shao Xin Cheng Hongxing Pan Zhijian Wang Yu Xia Jianfang Xu Xuefen Huai Danjing Leng Jiarong Wang Gan Zhao Bin Wang Jingxin Li Fengcai Zhu |
| author_facet | Siyue Jia Chengwei Shao Xin Cheng Hongxing Pan Zhijian Wang Yu Xia Jianfang Xu Xuefen Huai Danjing Leng Jiarong Wang Gan Zhao Bin Wang Jingxin Li Fengcai Zhu |
| author_sort | Siyue Jia |
| collection | DOAJ |
| description | INO-4800 represents a DNA-based vaccine encoding the spike protein of SARS-CoV-2. This phase 2 trial evaluated the immunogenicity and safety of INO-4800 as a primary vaccination series in adults. We conducted a randomized, observer-blind, placebo-controlled phase 2 trial of intradermal injection of INO-4800 in both healthy adults and elderly individuals. Eligible participants from each age group were enrolled and randomly assigned in a 3:3:2 ratio to receive two doses of INO-4800 (1.0 mg or 2.0 mg) or placebo, followed by electroporation on day 0 and day 28. The primary immunogenicity endpoints focused on determining the geometric mean titers (GMTs) of spike-binding antibodies and live SARS-CoV-2 neutralizing antibody at day 30 after the second dose. The primary endpoint for safety was the occurrence of adverse events within 30 days after vaccination. A total of 781 volunteers were recruited and screened for eligibility, with 320 eligible young adults (≥18 to <60 years old) and 320 elderly (≥60 to ≤85 years old) were randomly assigned to receive the low-dose (1.0 mg, n = 120) or high-dose (2.0 mg, n = 120) INO-4800, or placebo (n = 80). Notably, both dose groups exhibited significant increases in spike-binding antibodies at day 30 after the second dose, with GMTs of 1609.3 (95% CI: 1385.5–1869.3) for the low-dose group and 3016.7 (95% CI: 2577.4–3530.8) for the high-dose group. Additionally, both dose groups induced neutralizing antibodies against live SARS-CoV-2, with GMTs of 4.7 (95% CI: 4.2–5.3) and 6.6 (95% CI: 5.9–7.4) at day 30 after the second dose. The incidence of adverse events within 30 days after vaccination was slightly higher in the high-dose group (115 [47.9%]) than that in the low-dose group (105 [43.8%]) (p = .0060). All adverse reactions were grade 1 or 2, primarily occurring within 14 days after vaccination. No vaccine-related serious adverse events were reported. The COVID-19 DNA vaccine INO-4800 at two doses (1.0 mg or 2.0 mg) showed an acceptable safety profile and modest immunogenicity, with the high-dose slightly more immunogenic than the low-dose.Clinical Trials Registration: www.chictr.org.cn, identifier is ChiCTR2000040146. |
| format | Article |
| id | doaj-art-50751b87cee64affad13aef55c45e132 |
| institution | Kabale University |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
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| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-50751b87cee64affad13aef55c45e1322025-01-27T06:46:06ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2024.2448405Immunogenicity and safety of a COVID-19 DNA vaccine in healthy adults and elderly: A randomized, observer-blind, placebo-controlled phase 2 trialSiyue Jia0Chengwei Shao1Xin Cheng2Hongxing Pan3Zhijian Wang4Yu Xia5Jianfang Xu6Xuefen Huai7Danjing Leng8Jiarong Wang9Gan Zhao10Bin Wang11Jingxin Li12Fengcai Zhu13Jiangsu Provincial Medical Innovation Center, National Health Commission Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, ChinaSchool of Public Health, Southeast University, Nanjing, ChinaR&D Business Unit, Advaccine Biopharmaceuticals Suzhou Co., Ltd, Suzhou, ChinaJiangsu Provincial Medical Innovation Center, National Health Commission Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, ChinaDepartment of Acute Infectious Diseases and Immunization Program Management, Danyang Center for Disease Control and Prevention, Zhenjiang, ChinaR&D Business Unit, Advaccine Biopharmaceuticals Suzhou Co., Ltd, Suzhou, ChinaDepartment of Acute Infectious Diseases and Immunization Program Management, Danyang Center for Disease Control and Prevention, Zhenjiang, ChinaR&D Business Unit, Advaccine Biopharmaceuticals Suzhou Co., Ltd, Suzhou, ChinaDepartment of Acute Infectious Diseases and Immunization Program Management, Danyang Center for Disease Control and Prevention, Zhenjiang, ChinaR&D Business Unit, Advaccine Biopharmaceuticals Suzhou Co., Ltd, Suzhou, ChinaR&D Business Unit, Advaccine Biopharmaceuticals Suzhou Co., Ltd, Suzhou, ChinaR&D Business Unit, Advaccine Biopharmaceuticals Suzhou Co., Ltd, Suzhou, ChinaJiangsu Provincial Medical Innovation Center, National Health Commission Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, ChinaJiangsu Provincial Medical Innovation Center, National Health Commission Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, ChinaINO-4800 represents a DNA-based vaccine encoding the spike protein of SARS-CoV-2. This phase 2 trial evaluated the immunogenicity and safety of INO-4800 as a primary vaccination series in adults. We conducted a randomized, observer-blind, placebo-controlled phase 2 trial of intradermal injection of INO-4800 in both healthy adults and elderly individuals. Eligible participants from each age group were enrolled and randomly assigned in a 3:3:2 ratio to receive two doses of INO-4800 (1.0 mg or 2.0 mg) or placebo, followed by electroporation on day 0 and day 28. The primary immunogenicity endpoints focused on determining the geometric mean titers (GMTs) of spike-binding antibodies and live SARS-CoV-2 neutralizing antibody at day 30 after the second dose. The primary endpoint for safety was the occurrence of adverse events within 30 days after vaccination. A total of 781 volunteers were recruited and screened for eligibility, with 320 eligible young adults (≥18 to <60 years old) and 320 elderly (≥60 to ≤85 years old) were randomly assigned to receive the low-dose (1.0 mg, n = 120) or high-dose (2.0 mg, n = 120) INO-4800, or placebo (n = 80). Notably, both dose groups exhibited significant increases in spike-binding antibodies at day 30 after the second dose, with GMTs of 1609.3 (95% CI: 1385.5–1869.3) for the low-dose group and 3016.7 (95% CI: 2577.4–3530.8) for the high-dose group. Additionally, both dose groups induced neutralizing antibodies against live SARS-CoV-2, with GMTs of 4.7 (95% CI: 4.2–5.3) and 6.6 (95% CI: 5.9–7.4) at day 30 after the second dose. The incidence of adverse events within 30 days after vaccination was slightly higher in the high-dose group (115 [47.9%]) than that in the low-dose group (105 [43.8%]) (p = .0060). All adverse reactions were grade 1 or 2, primarily occurring within 14 days after vaccination. No vaccine-related serious adverse events were reported. The COVID-19 DNA vaccine INO-4800 at two doses (1.0 mg or 2.0 mg) showed an acceptable safety profile and modest immunogenicity, with the high-dose slightly more immunogenic than the low-dose.Clinical Trials Registration: www.chictr.org.cn, identifier is ChiCTR2000040146.https://www.tandfonline.com/doi/10.1080/21645515.2024.2448405COVID-19DNA vaccineimmunogenicitysafetyprimary immunization |
| spellingShingle | Siyue Jia Chengwei Shao Xin Cheng Hongxing Pan Zhijian Wang Yu Xia Jianfang Xu Xuefen Huai Danjing Leng Jiarong Wang Gan Zhao Bin Wang Jingxin Li Fengcai Zhu Immunogenicity and safety of a COVID-19 DNA vaccine in healthy adults and elderly: A randomized, observer-blind, placebo-controlled phase 2 trial Human Vaccines & Immunotherapeutics COVID-19 DNA vaccine immunogenicity safety primary immunization |
| title | Immunogenicity and safety of a COVID-19 DNA vaccine in healthy adults and elderly: A randomized, observer-blind, placebo-controlled phase 2 trial |
| title_full | Immunogenicity and safety of a COVID-19 DNA vaccine in healthy adults and elderly: A randomized, observer-blind, placebo-controlled phase 2 trial |
| title_fullStr | Immunogenicity and safety of a COVID-19 DNA vaccine in healthy adults and elderly: A randomized, observer-blind, placebo-controlled phase 2 trial |
| title_full_unstemmed | Immunogenicity and safety of a COVID-19 DNA vaccine in healthy adults and elderly: A randomized, observer-blind, placebo-controlled phase 2 trial |
| title_short | Immunogenicity and safety of a COVID-19 DNA vaccine in healthy adults and elderly: A randomized, observer-blind, placebo-controlled phase 2 trial |
| title_sort | immunogenicity and safety of a covid 19 dna vaccine in healthy adults and elderly a randomized observer blind placebo controlled phase 2 trial |
| topic | COVID-19 DNA vaccine immunogenicity safety primary immunization |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2448405 |
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