Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccine
Abstract Background Numerous vaccine strategies are being advanced to control SARS-CoV-2, the cause of the COVID-19 pandemic. EuCorVac-19 (ECV19) is a recombinant protein nanoparticle vaccine that displays the SARS-CoV-2 receptor-binding domain (RBD) on immunogenic nanoliposomes. Methods Initial stu...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-11-01
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| Series: | BMC Medicine |
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| Online Access: | https://doi.org/10.1186/s12916-022-02661-1 |
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| author | Jonathan F. Lovell Yeong Ok Baik Seuk Keun Choi Chankyu Lee Jeong-Yoon Lee Kazutoyo Miura Wei-Chiao Huang Young-Shin Park Sun-Je Woo Sang Hwan Seo Jae-Ouk Kim Manki Song Chung-Jong Kim Jae-Ki Choi Jieun Kim Eun Ju Choo Jung-Hyun Choi |
| author_facet | Jonathan F. Lovell Yeong Ok Baik Seuk Keun Choi Chankyu Lee Jeong-Yoon Lee Kazutoyo Miura Wei-Chiao Huang Young-Shin Park Sun-Je Woo Sang Hwan Seo Jae-Ouk Kim Manki Song Chung-Jong Kim Jae-Ki Choi Jieun Kim Eun Ju Choo Jung-Hyun Choi |
| author_sort | Jonathan F. Lovell |
| collection | DOAJ |
| description | Abstract Background Numerous vaccine strategies are being advanced to control SARS-CoV-2, the cause of the COVID-19 pandemic. EuCorVac-19 (ECV19) is a recombinant protein nanoparticle vaccine that displays the SARS-CoV-2 receptor-binding domain (RBD) on immunogenic nanoliposomes. Methods Initial study of a phase 2 randomized, observer-blind, placebo-controlled trial to assess the immunogenicity, safety, and tolerance of ECV19 was carried out between July and October 2021. Two hundred twenty-nine participants were enrolled at 5 hospital sites in South Korea. Healthy adults aged 19–75 without prior known exposure to COVID-19 were vaccinated intramuscularly on day 0 and day 21. Of the participants who received two vaccine doses according to protocol, 100 received high-dose ECV19 (20 μg RBD), 96 received low-dose ECV19 (10 μg RBD), and 27 received placebo. Local and systemic adverse events were monitored. Serum was assessed on days 0, 21, and 42 for immunogenicity analysis by ELISA and neutralizing antibody response by focus reduction neutralization test (FRNT). Results Low-grade injection site tenderness and pain were observed in most participants. Solicited systemic adverse events were less frequent, and mostly involved low-grade fatigue/malaise, myalgia, and headache. No clinical laboratory abnormalities were observed. Adverse events did not increase with the second injection and no serious adverse events were solicited by ECV19. On day 42, Spike IgG geometric mean ELISA titers were 0.8, 211, and 590 Spike binding antibody units (BAU/mL) for placebo, low-dose and high-dose ECV19, respectively (p < 0.001 between groups). Neutralizing antibodies levels of the low-dose and high-dose ECV19 groups had FRNT50 geometric mean values of 129 and 316, respectively. Boosting responses and dose responses were observed. Antibodies against the RBD correlated with antibodies against the Spike and with virus neutralization. Conclusions ECV19 was generally well-tolerated and induced antibodies in a dose-dependent manner that neutralized SARS-CoV-2. The unique liposome display approach of ECV19, which lacks any immunogenic protein components besides the antigen itself, coupled with the lack of increased adverse events during boosting suggest the vaccine platform may be amenable to multiple boosting regimes in the future. Taken together, these findings motivate further investigation of ECV19 in larger scale clinical testing that is underway. Trial registration The trial was registered at ClinicalTrials.gov as # NCT04783311. |
| first_indexed | 2024-04-11T07:18:49Z |
| format | Article |
| id | doaj.art-751995d68b8d49d3808a9e447b241469 |
| institution | Directory Open Access Journal |
| issn | 1741-7015 |
| language | English |
| last_indexed | 2024-04-11T07:18:49Z |
| publishDate | 2022-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medicine |
| spelling | doaj.art-751995d68b8d49d3808a9e447b2414692022-12-22T04:37:49ZengBMCBMC Medicine1741-70152022-11-0120111110.1186/s12916-022-02661-1Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccineJonathan F. Lovell0Yeong Ok Baik1Seuk Keun Choi2Chankyu Lee3Jeong-Yoon Lee4Kazutoyo Miura5Wei-Chiao Huang6Young-Shin Park7Sun-Je Woo8Sang Hwan Seo9Jae-Ouk Kim10Manki Song11Chung-Jong Kim12Jae-Ki Choi13Jieun Kim14Eun Ju Choo15Jung-Hyun Choi16Department of Biomedical Engineering, University at BuffaloEubiologics, R&D Center, EuBiologics Co., Ltd.Eubiologics, R&D Center, EuBiologics Co., Ltd.Eubiologics, R&D Center, EuBiologics Co., Ltd.Eubiologics, R&D Center, EuBiologics Co., Ltd.National Institute of Allergy and Infectious Diseases, National Institutes of HealthDepartment of Biomedical Engineering, University at BuffaloInternational Vaccine InstituteInternational Vaccine InstituteInternational Vaccine InstituteInternational Vaccine InstituteInternational Vaccine InstituteDepartment of Internal Medicine, Ewha Womans University Seoul HospitalCatholic University of Korea, Bucheon St. Mary’s HospitalHanyang University College of MedicineSoonchunhyang University Bucheon HospitalDepartment of Infectious Diseases, College of Medicine, Eunpyeong St. Mary’s Hospital, The Catholic University of KoreaAbstract Background Numerous vaccine strategies are being advanced to control SARS-CoV-2, the cause of the COVID-19 pandemic. EuCorVac-19 (ECV19) is a recombinant protein nanoparticle vaccine that displays the SARS-CoV-2 receptor-binding domain (RBD) on immunogenic nanoliposomes. Methods Initial study of a phase 2 randomized, observer-blind, placebo-controlled trial to assess the immunogenicity, safety, and tolerance of ECV19 was carried out between July and October 2021. Two hundred twenty-nine participants were enrolled at 5 hospital sites in South Korea. Healthy adults aged 19–75 without prior known exposure to COVID-19 were vaccinated intramuscularly on day 0 and day 21. Of the participants who received two vaccine doses according to protocol, 100 received high-dose ECV19 (20 μg RBD), 96 received low-dose ECV19 (10 μg RBD), and 27 received placebo. Local and systemic adverse events were monitored. Serum was assessed on days 0, 21, and 42 for immunogenicity analysis by ELISA and neutralizing antibody response by focus reduction neutralization test (FRNT). Results Low-grade injection site tenderness and pain were observed in most participants. Solicited systemic adverse events were less frequent, and mostly involved low-grade fatigue/malaise, myalgia, and headache. No clinical laboratory abnormalities were observed. Adverse events did not increase with the second injection and no serious adverse events were solicited by ECV19. On day 42, Spike IgG geometric mean ELISA titers were 0.8, 211, and 590 Spike binding antibody units (BAU/mL) for placebo, low-dose and high-dose ECV19, respectively (p < 0.001 between groups). Neutralizing antibodies levels of the low-dose and high-dose ECV19 groups had FRNT50 geometric mean values of 129 and 316, respectively. Boosting responses and dose responses were observed. Antibodies against the RBD correlated with antibodies against the Spike and with virus neutralization. Conclusions ECV19 was generally well-tolerated and induced antibodies in a dose-dependent manner that neutralized SARS-CoV-2. The unique liposome display approach of ECV19, which lacks any immunogenic protein components besides the antigen itself, coupled with the lack of increased adverse events during boosting suggest the vaccine platform may be amenable to multiple boosting regimes in the future. Taken together, these findings motivate further investigation of ECV19 in larger scale clinical testing that is underway. Trial registration The trial was registered at ClinicalTrials.gov as # NCT04783311.https://doi.org/10.1186/s12916-022-02661-1COVID-19SARS-CoV-2RBDVaccineLiposomeAdjuvant |
| spellingShingle | Jonathan F. Lovell Yeong Ok Baik Seuk Keun Choi Chankyu Lee Jeong-Yoon Lee Kazutoyo Miura Wei-Chiao Huang Young-Shin Park Sun-Je Woo Sang Hwan Seo Jae-Ouk Kim Manki Song Chung-Jong Kim Jae-Ki Choi Jieun Kim Eun Ju Choo Jung-Hyun Choi Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccine BMC Medicine COVID-19 SARS-CoV-2 RBD Vaccine Liposome Adjuvant |
| title | Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccine |
| title_full | Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccine |
| title_fullStr | Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccine |
| title_full_unstemmed | Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccine |
| title_short | Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccine |
| title_sort | interim analysis from a phase 2 randomized trial of eucorvac 19 a recombinant protein sars cov 2 rbd nanoliposome vaccine |
| topic | COVID-19 SARS-CoV-2 RBD Vaccine Liposome Adjuvant |
| url | https://doi.org/10.1186/s12916-022-02661-1 |
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