Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 최희정 | * |
dc.date.accessioned | 2023-10-19T16:31:04Z | - |
dc.date.available | 2023-10-19T16:31:04Z | - |
dc.date.issued | 2023 | * |
dc.identifier.issn | 2589-5370 | * |
dc.identifier.other | OAK-34210 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/266212 | - |
dc.description.abstract | Background: GBP510 vaccine contains self-assembling, recombinant nanoparticles displaying SARS-CoV-2 spike receptor-binding domains. We report interim phase 3 immunogenicity results for GBP510 adjuvanted with AS03 (GBP510/AS03) compared with ChAdOx1-S (Vaxzevria, AstraZeneca) in healthy adults aged ≥18 years, up to 6 months after the second dose. Methods: This was a randomised, active-controlled, observer-blinded, parallel group, phase 3 study, conducted at 38 sites across six countries (South Korea, Philippines, Thailand, Vietnam, Ukraine and New Zealand). Cohort 1 (no history of SARS-CoV-2 infection/COVID-19 vaccination) was randomised 2:1 to receive two doses of GBP510/AS03 or ChAdOx1-S (immunogenicity and safety), while Cohort 2 (regardless of baseline serostatus) was randomised 5:1 (safety). Primary objectives were to demonstrate superiority in geometric mean titre (GMT) and non-inferiority in seroconversion rate (SCR; ≥4-fold rise from baseline) of GBP510/AS03 vs. ChAdOx1-S for neutralising antibodies against the ancestral strain by live-virus neutralisation assay. Secondary objectives included assessment of safety and reactogenicity (long-term 6 months cut-off date: 09 August 2022). This study was registered on ClinicalTrials.gov (NCT05007951). Findings: Between 30 August 2021 and 11 January 2022, a total of 4913 participants were screened and 4036 participants (1956 in Cohort 1 and 2080 in Cohort 2) who met eligibility criteria were enrolled and randomised to receive 2 doses of GBP510/AS03 (n = 3039) or ChAdOx1-S (n = 997). Most participants were Southeast Asian (81.5%) and aged 18–64 years (94.7%). The primary objectives assessed in per-protocol set included 877 participants in GBP510/AS03 and 441 in ChAdOx1-S group: at 2 weeks after the second vaccination, the GMT ratio (GBP510/AS03/ChAdOx1-S) in per-protocol set was 2.93 (95% CI 2.63–3.27), demonstrating superiority (95% CI lower limit >1) of GBP510/AS03; the between-group SCR difference of 10.8% (95% CI 7.68–14.32) also satisfied the non-inferiority criterion (95% CI lower limit > −5%). Neutralizing antibody titres sustained higher for the GBP510/AS03 group compared to the ChAdOx1-S group through 6 months after the second vaccination. In Safety analysis (Cohort 1 & 2), the proportion of participants with adverse events (AEs) after any vaccination was higher with GBP510/AS03 vs. ChAdOx1-S for solicited local AEs (56.7% vs. 49.2%), but was similar for solicited systemic AEs (51.2% vs. 53.5%) and unsolicited AEs (13.3% vs. 14.6%) up to 28 days after the second vaccination. No safety concerns were identified during follow-up for 6 months after the second vaccination. Interpretation: Our interim findings suggested that GBP510/AS03 met the superiority criterion for neutralising antibodies and non-inferiority criterion for SCR compared with ChAdOx1-S, and showed a clinically acceptable safety profile. Funding: This work was supported, in whole or in part, by funding from CEPI and the Bill & Melinda Gates Foundation Investments INV-010680 and INV-006462. The Bill & Melinda Gates Foundation supported this project for the generation of IND-enabling data and CEPI supported this clinical study. © 2023 | * |
dc.language | English | * |
dc.publisher | Elsevier Ltd | * |
dc.subject | COVID-19 | * |
dc.subject | Immunogenicity | * |
dc.subject | Nanoparticle vaccine | * |
dc.subject | Recombinant protein vaccine | * |
dc.subject | Safety | * |
dc.subject | SARS-CoV-2 | * |
dc.title | Immunogenicity and safety of SARS-CoV-2 recombinant protein nanoparticle vaccine GBP510 adjuvanted with AS03: interim results of a randomised, active-controlled, observer-blinded, phase 3 trial | * |
dc.type | Article | * |
dc.relation.volume | 64 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.journaltitle | eClinicalMedicine | * |
dc.identifier.doi | 10.1016/j.eclinm.2023.102140 | * |
dc.identifier.wosid | WOS:001077457800001 | * |
dc.identifier.scopusid | 2-s2.0-85172927216 | * |
dc.author.google | Song | * |
dc.author.google | Joon Young | * |
dc.author.google | Choi | * |
dc.author.google | Won Suk | * |
dc.author.google | Heo | * |
dc.author.google | Jung Yeon | * |
dc.author.google | Kim | * |
dc.author.google | Eun Jin | * |
dc.author.google | Lee | * |
dc.author.google | Jin Soo | * |
dc.author.google | Jung | * |
dc.author.google | Dong Sik | * |
dc.author.google | Shin-Woo | * |
dc.author.google | Park | * |
dc.author.google | Kyung-Hwa | * |
dc.author.google | Eom | * |
dc.author.google | Joong Sik | * |
dc.author.google | Jeong | * |
dc.author.google | Su Jin | * |
dc.author.google | Jacob | * |
dc.author.google | Kwon | * |
dc.author.google | Ki Tae | * |
dc.author.google | Hee Jung | * |
dc.author.google | Sohn | * |
dc.author.google | Jang Wook | * |
dc.author.google | Young Keun | * |
dc.author.google | Yoo | * |
dc.author.google | Byung Wook | * |
dc.author.google | Jang | * |
dc.author.google | In-Jin | * |
dc.author.google | Capeding | * |
dc.author.google | Maria Z. | * |
dc.author.google | Roman | * |
dc.author.google | François | * |
dc.author.google | Breuer | * |
dc.author.google | Thomas | * |
dc.author.google | Wysocki | * |
dc.author.google | Piotr | * |
dc.author.google | Carter | * |
dc.author.google | Lauren | * |
dc.author.google | Sahastrabuddhe | * |
dc.author.google | Sushant | * |
dc.author.google | Manki | * |
dc.author.google | D'Cor | * |
dc.author.google | Naveena | * |
dc.author.google | Hun | * |
dc.author.google | Ryu | * |
dc.author.google | Ji Hwa | * |
dc.author.google | Su Jeen | * |
dc.author.google | Yong Wook | * |
dc.author.google | Cheong | * |
dc.author.google | Hee Jin | * |
dc.author.google | Philippot | * |
dc.author.google | Agathe | * |
dc.author.google | Solmi | * |
dc.author.google | Francesca | * |
dc.author.google | Ceregido | * |
dc.author.google | Maria Angeles | * |
dc.author.google | Shim | * |
dc.author.google | Byoung-Shik | * |
dc.author.google | Seo | * |
dc.author.google | Sang Hwan | * |
dc.author.google | D'Souza | * |
dc.author.google | Simone | * |
dc.author.google | Thaisrivichai | * |
dc.author.google | Patchara | * |
dc.author.google | Carlos | * |
dc.author.google | Josefina | * |
dc.author.google | Alberto | * |
dc.author.google | Edison | * |
dc.author.google | Nitayaphan | * |
dc.author.google | Sorachai | * |
dc.author.google | Ratanasuwan | * |
dc.author.google | Winai | * |
dc.author.google | Mootsikapun | * |
dc.author.google | Piroon | * |
dc.author.google | Chaiwarith | * |
dc.author.google | Romanee | * |
dc.author.google | Chan Quang | * |
dc.author.google | Luong | * |
dc.author.google | Karpenko | * |
dc.author.google | Olena | * |
dc.author.google | Yurkiv | * |
dc.author.google | Tatiana | * |
dc.author.google | Kutovyi | * |
dc.author.google | Vitalii | * |
dc.author.google | Bartko | * |
dc.author.google | Angela | * |
dc.author.google | Gyrina | * |
dc.author.google | Olga | * |
dc.author.google | Barna | * |
dc.author.google | Pugach | * |
dc.author.google | Mykhailo | * |
dc.author.google | Thurlow | * |
dc.author.google | Claire | * |
dc.author.google | Carson | * |
dc.author.google | Simon | * |
dc.author.google | Smith | * |
dc.author.google | Susan | * |
dc.author.google | Williams | * |
dc.author.google | Mike | * |
dc.author.google | Hemi Senior | * |
dc.author.google | Tiwini | * |
dc.author.google | Humphrey | * |
dc.author.google | Tim | * |
dc.author.google | Sheahan | * |
dc.author.google | Davitt | * |
dc.author.google | Hokeun | * |
dc.author.google | Yoon Yeong | * |
dc.author.google | Kang | * |
dc.author.google | Seung Gu | * |
dc.contributor.scopusid | 최희정(57217262202) | * |
dc.date.modifydate | 20240422112010 | * |