A Phase III, Randomized, Observer-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate Immunogenicity and Safety of a Preventive COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older

This is a phase III, randomized, observer-blind, active-controlled, parallel group, multi-center study to compare the immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 to ChAdOx1 in healthy adults aged 18 years and older

开始日期2022-10-01

申办/合作机构

EuBiologics Co., Ltd.

NCT05603052 / Completed临床3期

A phase III, randomized, observer-blind, active-controlled, parallel-group, multi-center study to evaluate immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 in healthy adults aged 18 years and older

开始日期2022-07-11

申办/合作机构

EuBiologics Co., Ltd.

NCT04783311 / Completed临床1/2期

A Phase 1/2 Dose-exploration, Randomized, Observer-blind, Placebo-controlled Study to Determine Safety, Tolerance and Immunogenicity of EuCorVac-19, a Recombinant Protein Vaccine, for the Prevention of COVID-19 in Healthy Adults

Phase I/II study to determine safety, tolerance and immunogenicity of EuCorVac-19, a recombinant protein vaccine, for the prevention of COVID-19 in healthy adults

开始日期2021-02-23

申办/合作机构

EuBiologics Co., Ltd.

100 项与 EuCorVac-19 相关的临床结果

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100 项与 EuCorVac-19 相关的转化医学

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100 项与 EuCorVac-19 相关的专利（医药）

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项与 EuCorVac-19 相关的文献（医药）

2024-03-01·Biotechnology and Bioengineering

Engineering Escherichia coli for constitutive production of monophosphoryl lipid A vaccine adjuvant

Article

作者: Lee, Chankyu ; Lee, Choon Geun ; Lee, Ye‐Ram ; Yang, Eun Gyeong ; Kwon, Ick Chan ; Kim, Ki Hun ; Chung, Hak Suk ; Ji, Yuhyun ; Jeong, Wooyeon ; Ha, Da Hui ; Jin, Hyunjung ; An, Jinsu ; Kim, Hye‐Ji

AbstractDuring the COVID‐19 pandemic, expedient vaccine production has been slowed by the shortage of safe and effective raw materials, such as adjuvants, essential components to enhance the efficacy of vaccines. Monophosphoryl lipid A (MPLA) is a potent and safe adjuvant used in human vaccines, including the Shingles vaccine, Shingrix. 3‐O‐desacyl‐4′‐monophosphoryl lipid A (MPL), a representative MPLA adjuvant commercialized by GSK, was prepared via chemical conversion of precursors isolated from Salmonella typhimurium R595. However, the high price of these materials limits their use in premium vaccines. To combat the scarcity and high cost of safe raw materials for vaccines, we need to develop a feasible MPLA production method that is easily scaled up to meet industrial requirements. In this study, we engineered peptidoglycan and outer membrane biosynthetic pathways in Escherichia coli and developed a Escherichia coli strain, KHSC0055, that constitutively produces EcML (E. coli‐produced monophosphoryl lipid A) without additives such as antibiotics or overexpression inducers. EcML production was optimized on an industrial scale via high‐density fed‐batch fermentation, and obtained 2.7 g of EcML (about 135,000 doses of vaccine) from a 30‐L‐scale fermentation. Using KHSC0055, we simplified the production process and decreased the production costs of MPLA. Then, we applied EcML purified from KHSC0055 as an adjuvant for a COVID‐19 vaccine candidate (EuCorVac‐19) currently in clinical trial stage III in the Philippines. By probing the efficacy and safety of EcML in humans, we established KHSC0055 as an efficient cell factory for MPLA adjuvant production.

2024-01-01·International Journal of Infectious Diseases

One-year antibody durability induced by EuCorVac-19, a liposome-displayed COVID-19 receptor binding domain subunit vaccine, in healthy Korean subjects

Article

作者: Hong, Ingi ; Lee, Jung Hyuk ; Kim, Chung-Jong ; Kim, Jae-Ouk ; Choo, Eun Ju ; Kim, Jieun ; Seo, Sang Hwan ; Lee, Chankyu ; Song, Manki ; Park, Young-Shin ; Lee, Jeong-Yoon ; Lovell, Jonathan F ; Choi, Jung-Hyun ; Baik, Yeong Ok ; Choi, Jae-Ki ; Kim, Taewoo ; Miura, Kazutoyo

OBJECTIVEEuCorVac-19 (ECV-19), an adjuvanted liposome-displayed receptor binding domain (RBD) COVID-19 vaccine, previously reported interim Phase 2 trial results showing induction of neutralizing antibodies 3 weeks after prime-boost immunization. The objective of this study was to determine the longer-term antibody response of the vaccine.METHODSTo assess immunogenicity 6 and 12 months after vaccination, participants in the Phase 2 trial (NCT04783311) were excluded if they: 1) withdrew, 2) reported COVID-19 infection or additional vaccination, or 3) exhibited increasing Spike (S) antibodies (representing possible non-reported infection). Following exclusions, of the 197 initial subjects, anti-S IgG antibodies and neutralizing antibodies were further assessed in 124 subjects at the 6-month timepoint, and 36 subjects at the 12-month timepoint.RESULTSMedian anti-S antibody half-life was 52 days (interquartile range [IQR]:42-70), in the "early" period from 3 weeks to 6 months, and 130 days (IQR:97-169) in the "late" period from 6 to 12 months. There was a negative correlation between initial antibody titer and half-life. Anti-S and neutralizing antibody responses were correlated. Neutralizing antibody responses showed longer half-lives; the early period had a median half-life of 120 days (IQR:81-207), and the late period had a median half-life of 214 days (IQR:140-550).CONCLUSIONThese data establish antibody durability of ECV-19, using a framework to analyze COVID-19 vaccine-induced antibodies during periods of high infection.

BMC Medicine

Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccine

Article

作者: Baik, Yeong Ok ; Choi, Jae-Ki ; Choo, Eun Ju ; Kim, Jae-Ouk ; Woo, Sun-Je ; Song, Manki ; Lee, Jeong-Yoon ; Huang, Wei-Chiao ; Lee, Chankyu ; Choi, Seuk Keun ; Choi, Jung-Hyun ; Lovell, Jonathan F ; Park, Young-Shin ; Kim, Chung-Jong ; Seo, Sang Hwan ; Miura, Kazutoyo ; Kim, Jieun

AbstractBackgroundNumerous 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.MethodsInitial 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).ResultsLow-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.ConclusionsECV19 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 registrationThe trial was registered at ClinicalTrials.gov as # NCT04783311.

100 项与 EuCorVac-19 相关的药物交易

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