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健康菲律宾人对EuCorVac-19新冠疫苗的长期抗体反应。

Year-Long Antibody Response to the EuCorVac-19 SARS-CoV-2 Vaccine in Healthy Filipinos.

作者信息

Lovell Jonathan F, Miura Kazutoyo, Baik Yeong Ok, Lee Chankyu, Choi YoungJin, Lee Jeong-Yoon, Long Carole A, Ylade Michelle, Lee-Llacer Roxas, De Asis Norman, Trinidad-Aseron Mitzi, Manuel Ranola Jose, Zoleta De Jesus Loreta, Her Howard

机构信息

Department of Biomedical Engineering, University at Buffalo, Buffalo, NY 14260, USA.

Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20892, USA.

出版信息

Vaccines (Basel). 2025 Jul 22;13(8):776. doi: 10.3390/vaccines13080776.

Abstract

We previously reported an interim safety and immunogenicity analysis of a Phase 3 trial in the Philippines of the EuCorVac-19 (ECV-19) COVID-19 vaccine with the COVISHIELD (CS) comparator (ClinicalTrials.gov identifier NCT05572879). Here, we present full-year humoral immunogenicity analysis. : Healthy adults over 18 years of age received two injections of ECV-19 or CS vaccines, with 4 weeks between prime and boost. Analysis was carried out in individuals with immunogenicity measurements available at all 4 timepoints (weeks 0, 6, 30, and 56; = 535 for ECV-19 and = 260 for CS). : 2 weeks after boosting (week 6), ECV-19 elicited higher median anti-RBD IgG (1512 vs. 340 BAU/mL, < 0.001) and neutralizing antibodies (1280 vs. 453 median microneutralization (MN) titer, < 0.001) compared to CS. Anti-RBD IgG remained higher for ECV-19 compared to CS through week 30 (412 vs. 238 BAU/mL, < 0.001) and 56 (425 vs. 260 BAU/mL, < 0.001). MN titers remained higher for ECV-19 compared to CS through week 30 (640 vs. 453, < 0.001) and 56 (453 vs. 320, < 0.001). Correlation between anti-RBD IgG and neutralization titers persisted throughout the study. Women generally exhibited greater antibody responses than men. In the first six months following immunization, the ECV-19 group had a median antibody half-life of 80 days for anti-RBD IgG and 112 days for MN titer. In the subsequent six months, antibody half-life increased to 237 days for anti-RBD IgG and 168 days for MN titer. : Following initial prime-boost vaccination, ECV-19 maintained higher anti-RBD IgG and neutralizing antibody titers relative to the CS comparator over a full-year period.

摘要

我们之前报告了在菲律宾进行的一项3期试验的中期安全性和免疫原性分析,该试验将EuCorVac-19(ECV-19)新冠疫苗与COVISHIELD(CS)对照疫苗进行比较(ClinicalTrials.gov标识符NCT05572879)。在此,我们展示全年的体液免疫原性分析结果。18岁以上的健康成年人接受两剂ECV-19或CS疫苗注射,初免和加强免疫之间间隔4周。对在所有4个时间点(第0、6、30和56周;ECV-19组n = 535,CS组n = 260)均有免疫原性测量值的个体进行分析。加强免疫后2周(第6周),与CS相比,ECV-19诱导产生更高的抗受体结合域(RBD)IgG中位数(1512 vs. 340 BAU/mL,P < 0.001)和中和抗体(1280 vs. 453中位数微量中和(MN)滴度,P < 0.001)。与CS相比,ECV-19的抗RBD IgG在第30周(412 vs. 238 BAU/mL,P < 0.001)和第56周(425 vs. 260 BAU/mL,P < 0.001)时仍更高。与CS相比,ECV-19的MN滴度在第30周(640 vs. 453,P < 0.001)和第56周(453 vs. 320,P < 0.001)时也更高。在整个研究过程中,抗RBD IgG与中和滴度之间存在相关性。女性通常比男性表现出更强的抗体反应。在免疫后的前六个月,ECV-19组抗RBD IgG的抗体半衰期中位数为80天,MN滴度的抗体半衰期中位数为112天。在随后的六个月中,抗RBD IgG的抗体半衰期增加到237天,MN滴度的抗体半衰期增加到168天。在初次进行初免-加强免疫接种后,在一整年的时间里,相对于CS对照疫苗,ECV-19维持了更高的抗RBD IgG和中和抗体滴度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1016/12389930/696292c8d786/vaccines-13-00776-g001.jpg

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