异源 SCB-2019 疫苗对科兴疫苗 primed 成年人对奥密克戎 SARS-CoV-2 变异株中和滴度的增强作用优于同源加强针。
Superior Boosting of Neutralizing Titers Against Omicron SARS-CoV-2 Variants by Heterologous SCB-2019 Vaccine vs a Homologous Booster in CoronaVac-Primed Adults.
机构信息
Department of Physiology, Philippine General Hospital, University of the Philippines, Manila, Philippines.
Las Pinas Doctors Hospital, Las Pinas City, Philippines.
出版信息
J Infect Dis. 2023 Nov 2;228(9):1253-1262. doi: 10.1093/infdis/jiad262.
BACKGROUND
We compared homologous and heterologous boosting in adults in the Philippines primed with 2 or 3 doses of CoronaVac, with recombinant protein vaccine, SCB-2019.
METHODS
CoronaVac-immunized adults (18-72 years) received a homologous or heterologous full or half dose SCB-2019 booster. We assessed all neutralizing antibody (NAb) responses against prototype SARS-CoV-2 after 15 days and NAb against SARS-CoV-2 Delta and Omicron variants in subsets (30‒50 per arm). Participants recorded adverse events.
RESULTS
In 2-dose CoronaVac-primed adults prototype NAb geometric mean titers (GMT) were 203 IU/mL (95% confidence interval [CI], 182-227) and 939 IU/mL (95% CI, 841-1049) after CoronaVac and SCB-2019 boosters; the GMT ratio (4.63; 95% CI, 3.95-5.41) met predefined noninferiority and post-hoc superiority criteria. After 3-dose CoronaVac-priming prototype NAb GMTs were 279 IU/mL (95% CI, 240-325), 1044 IU/mL (95% CI, 898-1213), and 668 IU/mL (95% CI, 520-829) following CoronaVac, full and half-dose SCB-2019 boosters, respectively. NAb GMT ratios against Delta and Omicron comparing SCB-2019 with CoronaVac were all greater than 2. Mild to moderate reactogenicity was evenly balanced between groups. No vaccine-related serious adverse events were reported.
CONCLUSIONS
Full or half dose SCB-2019 boosters were well tolerated with superior immunogenicity than homologous CoronaVac, particularly against newly emerged variants. Clinical Trials Registration. NCT05188677.
背景
我们比较了在菲律宾，使用科兴新冠疫苗（CoronaVac）进行 2 或 3 剂接种的成年人中同源和异源加强免疫，以及使用重组蛋白疫苗 SCB-2019 进行异源加强免疫。
方法
CoronaVac 免疫的成年人（18-72 岁）接受同源或异源全或半剂量的 SCB-2019 加强免疫。我们在第 15 天评估了所有针对原型 SARS-CoV-2 的中和抗体（NAb）反应，并在亚组（每组 30-50 人）中评估了针对 SARS-CoV-2 Delta 和 Omicron 变体的 NAb。参与者记录了不良反应。
结果
在 2 剂 CoronaVac 免疫的成年人中，原型 NAb 的几何平均滴度（GMT）分别为接种 CoronaVac 和 SCB-2019 加强免疫后的 203 IU/mL（95%置信区间[CI]，182-227）和 939 IU/mL（95% CI，841-1049）；GMT 比值（4.63；95% CI，3.95-5.41）符合预先设定的非劣效性和事后优越性标准。在 3 剂 CoronaVac 免疫的成年人中，原型 NAb 的 GMT 分别为接种 CoronaVac、全剂量和半剂量 SCB-2019 加强免疫后的 279 IU/mL（95% CI，240-325）、1044 IU/mL（95% CI，898-1213）和 668 IU/mL（95% CI，520-829）。与 CoronaVac 相比，针对 Delta 和 Omicron 的 SCB-2019 的 NAb GMT 比值均大于 2。各组之间的轻度至中度不良反应发生率相当平衡。未报告与疫苗相关的严重不良事件。
结论
全剂量或半剂量的 SCB-2019 加强免疫具有良好的耐受性，其免疫原性优于同源的 CoronaVac，尤其是针对新出现的变体。
临床试验注册
NCT05188677。
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