Long Term Follow-Up Study of a Randomized, Open-Label, Uncontrolled, Phase I/II Study to Assess the Safety and Immunogenicity of Intramuscular and Intradermal Doses of COVID-19 DNA Vaccine (AG0302-COVID19)
Pharmacological studies have demonstrated antibody production and infection prevention with an intradermal coronavirus disease 2019 (COVID-19) DNA vaccine (AG0302-COVID-19). This clinical trial aimed to investigate the safety and immunogenicity of high doses of AG0302-COVID19 when injected intramusc...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-09-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/11/10/1535 |
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| author | Hironori Nakagami Tetsuya Matsumoto Kenji Takazawa Hisakuni Sekino Osamu Matsuoka Satoshi Inoue Hidetoshi Furuie Ryuichi Morishita |
| author_facet | Hironori Nakagami Tetsuya Matsumoto Kenji Takazawa Hisakuni Sekino Osamu Matsuoka Satoshi Inoue Hidetoshi Furuie Ryuichi Morishita |
| author_sort | Hironori Nakagami |
| collection | DOAJ |
| description | Pharmacological studies have demonstrated antibody production and infection prevention with an intradermal coronavirus disease 2019 (COVID-19) DNA vaccine (AG0302-COVID-19). This clinical trial aimed to investigate the safety and immunogenicity of high doses of AG0302-COVID19 when injected intramuscularly and intradermally. Healthy adults were randomly divided into three intramuscular vaccination groups (2 mg, three times at 2-week intervals; 4 mg, twice at 4-week intervals; and 8 mg, twice at 4-week intervals) and two intradermal groups (1 mg, three times at 2-week intervals or twice at 4-week intervals). After a one-year follow-up, no serious adverse events were related to AG0302-COVID-19. At Week 52, the changes in the geometric mean titer (GMT) ratios of the anti-S antibodies were 2.5, 2.4, and 3.2 in the 2, 4, and 8 mg intramuscular groups, respectively, and 3.2 and 5.1 in the three times and twice injected intradermal groups, respectively. The number of INF-γ-producing cells responsive to S protein increased after the first dose and was sustained for several months. AG0302-COVID-19 showed an acceptable safety profile, but the induction of a humoral immune response was insufficient to justify progressing to a Phase 3 program. |
| first_indexed | 2024-03-10T20:50:05Z |
| format | Article |
| id | doaj.art-a0f01100bcac438b88a2e1706328b66e |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-10T20:50:05Z |
| publishDate | 2023-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-a0f01100bcac438b88a2e1706328b66e2023-11-19T18:24:08ZengMDPI AGVaccines2076-393X2023-09-011110153510.3390/vaccines11101535Long Term Follow-Up Study of a Randomized, Open-Label, Uncontrolled, Phase I/II Study to Assess the Safety and Immunogenicity of Intramuscular and Intradermal Doses of COVID-19 DNA Vaccine (AG0302-COVID19)Hironori Nakagami0Tetsuya Matsumoto1Kenji Takazawa2Hisakuni Sekino3Osamu Matsuoka4Satoshi Inoue5Hidetoshi Furuie6Ryuichi Morishita7Department of Health Development and Medicine, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita 565-0871, JapanDepartment of Infectious Diseases, Graduate School of Medicine, International University of Health and Welfare, Narita Hospital, 852 Hatakeda Narita, Chiba 286-0124, JapanMedical Corporation Shinanokai Shinanozaka Clinic, 20 Samon-cho, Shinjuku-ku, Tokyo 160-0017, JapanSekino Clinical Pharmacology Clinic, 3-28-3 Ikebukuro, Toshima-Ku, Tokyo 171-0014, JapanMedical Corporation Heishinkai ToCROM Clinic, 4-9, Yotsuyasanei-cho, Shinjuku-ku, Tokyo 160-0008, JapanMedical Corporation Heishinkai OCROM Clinic, 4-12-11, Kasuga, Suita 565-0853, JapanOsaka Pharmacology Clinical Research Hospital, 4-1-29, Miyahara, Yodogawa-ku, Osaka 532-0003, JapanDepartment of Clinical Gene Therapy, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita 565-0871, JapanPharmacological studies have demonstrated antibody production and infection prevention with an intradermal coronavirus disease 2019 (COVID-19) DNA vaccine (AG0302-COVID-19). This clinical trial aimed to investigate the safety and immunogenicity of high doses of AG0302-COVID19 when injected intramuscularly and intradermally. Healthy adults were randomly divided into three intramuscular vaccination groups (2 mg, three times at 2-week intervals; 4 mg, twice at 4-week intervals; and 8 mg, twice at 4-week intervals) and two intradermal groups (1 mg, three times at 2-week intervals or twice at 4-week intervals). After a one-year follow-up, no serious adverse events were related to AG0302-COVID-19. At Week 52, the changes in the geometric mean titer (GMT) ratios of the anti-S antibodies were 2.5, 2.4, and 3.2 in the 2, 4, and 8 mg intramuscular groups, respectively, and 3.2 and 5.1 in the three times and twice injected intradermal groups, respectively. The number of INF-γ-producing cells responsive to S protein increased after the first dose and was sustained for several months. AG0302-COVID-19 showed an acceptable safety profile, but the induction of a humoral immune response was insufficient to justify progressing to a Phase 3 program.https://www.mdpi.com/2076-393X/11/10/1535COVID-19DNA vaccineSARS-CoV-2 |
| spellingShingle | Hironori Nakagami Tetsuya Matsumoto Kenji Takazawa Hisakuni Sekino Osamu Matsuoka Satoshi Inoue Hidetoshi Furuie Ryuichi Morishita Long Term Follow-Up Study of a Randomized, Open-Label, Uncontrolled, Phase I/II Study to Assess the Safety and Immunogenicity of Intramuscular and Intradermal Doses of COVID-19 DNA Vaccine (AG0302-COVID19) Vaccines COVID-19 DNA vaccine SARS-CoV-2 |
| title | Long Term Follow-Up Study of a Randomized, Open-Label, Uncontrolled, Phase I/II Study to Assess the Safety and Immunogenicity of Intramuscular and Intradermal Doses of COVID-19 DNA Vaccine (AG0302-COVID19) |
| title_full | Long Term Follow-Up Study of a Randomized, Open-Label, Uncontrolled, Phase I/II Study to Assess the Safety and Immunogenicity of Intramuscular and Intradermal Doses of COVID-19 DNA Vaccine (AG0302-COVID19) |
| title_fullStr | Long Term Follow-Up Study of a Randomized, Open-Label, Uncontrolled, Phase I/II Study to Assess the Safety and Immunogenicity of Intramuscular and Intradermal Doses of COVID-19 DNA Vaccine (AG0302-COVID19) |
| title_full_unstemmed | Long Term Follow-Up Study of a Randomized, Open-Label, Uncontrolled, Phase I/II Study to Assess the Safety and Immunogenicity of Intramuscular and Intradermal Doses of COVID-19 DNA Vaccine (AG0302-COVID19) |
| title_short | Long Term Follow-Up Study of a Randomized, Open-Label, Uncontrolled, Phase I/II Study to Assess the Safety and Immunogenicity of Intramuscular and Intradermal Doses of COVID-19 DNA Vaccine (AG0302-COVID19) |
| title_sort | long term follow up study of a randomized open label uncontrolled phase i ii study to assess the safety and immunogenicity of intramuscular and intradermal doses of covid 19 dna vaccine ag0302 covid19 |
| topic | COVID-19 DNA vaccine SARS-CoV-2 |
| url | https://www.mdpi.com/2076-393X/11/10/1535 |
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