{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T20:15:28Z","timestamp":1792181728078,"version":"4.4.0"},"reference-count":24,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,9,24]],"date-time":"2024-09-24T00:00:00Z","timestamp":1727136000000},"content-version":"vor","delay-in-days":23,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    EuCorVac\u201019 (ECV\u201019) is a recombinant receptor binding domain (RBD) COVID\u201019 vaccine that displays the RBD (derived from the SARS\u2010CoV\u20102 Wuhan strain) on immunogenic liposomes. This study compares the safety and immunogenicity of ECV\u201019 to the COVISHIELD\n                    <jats:sup>TM<\/jats:sup>\n                    (CS) adenoviral\u2010vectored vaccine. Interim analysis is presented of a randomized, observer\u2010blind, immunobridging Phase 3 trial in the Philippines in 2600 subjects, with treatment and biospecimen collection between October 2022 and January 2023. Healthy male and female adults who received investigational vaccines were 18 years and older, and randomly assigned to ECV\u201019 (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20092004) or CS (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009596) groups. Immunization followed a two\u2010injection, intramuscular regimen with 4 weeks between prime and boost vaccination. Safety endpoints were assessed in all participants and immunogenicity analysis was carried out in a subset (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009585 in ECV\u201019 and\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009290 in CS groups). The primary immunological endpoints were superiority of neutralizing antibody response, as well as noninferiority in seroresponse rate (defined as a 4\u2010fold increase in RBD antibody titers from baseline). After prime vaccination, ECV\u201019 had a lower incidence of local solicited adverse events (AEs) (12.0% vs. 15.8%,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.01), and solicited systemic AEs (13.1 vs. 17.4%,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.01) relative to CS. After the second injection, both ECV\u201019 and CS had lower overall solicited AEs (7.8% vs. 7.6%). For immunological assessment, 98% of participants had prior COVID\u201019 exposure (based on the presence of anti\u2010nucleocapsid antibodies) at the time of the initial immunization, without differing baseline antibody levels or microneutralization (MN) titers against the Wuhan strain in the two groups. After prime vaccination, ECV\u201019 induced higher anti\u2010RBD IgG relative to CS (1,464 vs. 355 BAU\/mL,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.001) and higher neutralizing antibody response (1,303 vs. 494 MN titer,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.001). After boost vaccination, ECV\u201019 and CS maintained those levels of anti\u2010RBD IgG (1367 vs. 344 BAU\/mL,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.001) and neutralizing antibodies (1128 vs. 469 MN titer,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.001). ECV\u201019 also elicited antibodies that better neutralized the Omicron variant, compared to CS (763 vs. 373 MN titer,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.001). Women displayed higher responses to both vaccines than men. The ECV\u201019 group had a greater seroresponse rate compared to CS (83% vs. 30%,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.001). In summary, both ECV\u201019 and CS had favorable safety profiles, with ECV\u201019 showing diminished local and systemic solicited AE after prime immunization. ECV\u201019 had significantly greater immunogenicity in terms of anti\u2010RBD IgG, neutralizing antibodies, and seroresponse rate. These data establish a relatively favorable safety and immunogenicity profile for ECV\u201019. The trial is registered on\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                    (NCT05572879).\n                  <\/jats:p>","DOI":"10.1002\/jmv.29927","type":"journal-article","created":{"date-parts":[[2024,9,25]],"date-time":"2024-09-25T10:36:28Z","timestamp":1727260588000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Interim safety and immunogenicity analysis of the EuCorVac\u201019 COVID\u201019 vaccine in a Phase 3 randomized, observer\u2010blind, immunobridging trial in the Philippines"],"prefix":"10.1002","volume":"96","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9052-884X","authenticated-orcid":false,"given":"Jonathan F.","family":"Lovell","sequence":"first","affiliation":[{"name":"Department of Biomedical Engineering University at Buffalo Buffalo New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazutoyo","family":"Miura","sequence":"additional","affiliation":[{"name":"Laboratory of Malaria and Vector Research National Institute of Allergy and Infectious Diseases, National Institutes of Health Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yeong Ok","family":"Baik","sequence":"additional","affiliation":[{"name":"EuBiologics, R&amp;D Center, EuBiologics Co., Ltd. Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chankyu","family":"Lee","sequence":"additional","affiliation":[{"name":"EuBiologics, R&amp;D Center, EuBiologics Co., Ltd. Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"YoungJin","family":"Choi","sequence":"additional","affiliation":[{"name":"EuBiologics, R&amp;D Center, EuBiologics Co., Ltd. Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Howard","family":"Her","sequence":"additional","affiliation":[{"name":"EuBiologics, R&amp;D Center, EuBiologics Co., Ltd. Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeong\u2010Yoon","family":"Lee","sequence":"additional","affiliation":[{"name":"EuBiologics, R&amp;D Center, EuBiologics Co., Ltd. Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Ylade","sequence":"additional","affiliation":[{"name":"National Institutes of Health University of the Philippines Manila Manila Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roxas","family":"Lee\u2010Llacer","sequence":"additional","affiliation":[{"name":"Bicol Regional Training and Teaching Hospital Albay Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norman","family":"De Asis","sequence":"additional","affiliation":[{"name":"Norzel Medical &amp; Diagnostic Clinic Cebu City Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitzi","family":"Trinidad\u2010Aseron","sequence":"additional","affiliation":[{"name":"University of Perpetual Help System DALTA Manila Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose Manuel","family":"Ranola","sequence":"additional","affiliation":[{"name":"St John Hospital Inc Camarines Sur Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Loreta Zoleta","family":"De Jesus","sequence":"additional","affiliation":[{"name":"Silang Specialists Medical Center, Cavite  Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,9,24]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-022-05522-2"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-023-02664-2"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15552"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/adma.202107781"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41541-021-00393-6"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-022-02661-1"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijid.2023.11.004"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2021.05.063"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.3201\/eid2902.221422"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(22)00502-3"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.3390\/vaccines10050655"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2022.10.030"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2105290"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mjafi.2021.06.032"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2023.102140"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.25986"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.3390\/vaccines11101613"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1080\/21645515.2023.2203632"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2022.106700"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jinf.2021.12.003"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2022.981350"},{"issue":"4","key":"e_1_2_10_23_1","first-page":"1493","article-title":"Durability and immunogenicity of neutralizing antibodies response against omicron variants after three doses of subunit SARS\u2010CoV\u20102 vaccine MVC\u2010COV1901: an extension to an open\u2010label, dose\u2010escalation phase 1 study","volume":"11","author":"Hsieh SM","year":"2022","journal-title":"Infect Dis Ther"},{"key":"e_1_2_10_24_1","article-title":"Kinetics and durability of humoral responses to SARS\u2010CoV\u20102 infection and vaccination","author":"Srivastava K","year":"2023","journal-title":"medRxiv"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-022-02031-7"}],"container-title":["Journal of Medical 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