Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi, Bangkok 10400, Thailand.
Phaholpolpayuhasena Hospital, 572 Saeng Chuto Road Muang, Kanchanaburi 71000, Thailand.
Vaccine. 2023 Jul 19;41(32):4648-4657. doi: 10.1016/j.vaccine.2023.06.043. Epub 2023 Jun 15.
The inactivated COVID-19 whole-virus vaccine BBIBP-CorV has been extensively used worldwide. Heterologous boosting after primary vaccination can induce higher immune responses against SARS-CoV-2 than homologous boosting. The safety and immunogenicity after 28 days of a single Ad26.COV2.S booster dose given at different intervals after 2 doses of BBIBP-CorV are presented.
This open-label phase 1/2 trial was conducted in healthy adults in Thailand who had completed 2-dose primary vaccination with BBIBP-CorV. Participants received a single booster dose of Ad26.COV2.S (5 × 10 virus particles) 90-240 days (Group A1; n = 360) or 45-75 days (Group A2; n = 66) after the second BBIBP-CorV dose. Safety and immunogenicity were assessed over 28 days. Binding IgG antibodies to the full-length pre-fusion Spike and anti-nucleocapsid proteins of SARS-CoV-2 were measured by enzyme-linked immunosorbent assay. The SARS-CoV-2 pseudovirus neutralization assay and live virus microneutralization assay were used to quantify the neutralizing activity of antibodies against ancestral SARS-CoV-2 (Wuhan-Hu-1) and the delta (B.1.617.2) and omicron (B.1.1.529/BA.1 and BA.2) variants. The cell-mediated immune response was measured using a quantitative interferon (IFN)-γ release assay in whole blood.
Solicited local and systemic adverse events (AEs) on days 0-7 were mostly mild, as were unsolicited vaccine-related AEs during days 0-28, with no serious AEs. On day 28, anti-Spike binding antibodies increased from baseline by 487- and 146-fold in Groups A1 and A2, and neutralizing antibodies against ancestral SARS-CoV-2 by 55- and 37-fold, respectively. Humoral responses were strongest against ancestral SARS-CoV-2, followed by the delta, then the omicron BA.2 and BA.1 variants. T-cell-produced interferon-γ increased approximately 10-fold in both groups.
A single heterologous Ad26.COV2.S booster dose after two BBIBP-CorV doses was well tolerated and induced robust humoral and cell-mediated immune responses measured at day 28 in both interval groups.
NCT05109559.
已在全球广泛使用的新冠灭活全病毒疫苗 BBIBP-CorV。与同源增强相比，初级免疫接种后进行异源增强可诱导针对 SARS-CoV-2 的更高免疫应答。现将介绍两剂 BBIBP-CorV 后不同间隔时间给予单次 Ad26.COV2.S 增强剂后 28 天的安全性和免疫原性。
本开放标签的 1/2 期试验在已完成两剂 BBIBP-CorV 初级免疫接种的泰国健康成年人中进行。参与者接受单次 Ad26.COV2.S（5×10 病毒颗粒）增强剂剂量，两剂 BBIBP-CorV 后 90-240 天（A1 组；n=360）或 45-75 天（A2 组；n=66）。在 28 天内评估安全性和免疫原性。通过酶联免疫吸附试验测量针对全长预融合 Spike 和 SARS-CoV-2 核衣壳蛋白的结合 IgG 抗体。使用 SARS-CoV-2 假病毒中和测定法和活病毒微量中和测定法来量化针对原始 SARS-CoV-2（武汉-Hu-1）和 delta（B.1.617.2）以及 omicron（B.1.1.529/BA.1 和 BA.2）变体的抗体的中和活性。使用全血中的定量干扰素（IFN）-γ释放测定法测量细胞介导的免疫应答。
第 0-7 天的局部和全身不良事件（AE）大多为轻度，第 0-28 天的疫苗相关不良事件也为轻度，无严重不良事件。第 28 天，A1 和 A2 组的抗 Spike 结合抗体分别比基线增加了 487 倍和 146 倍，针对原始 SARS-CoV-2 的中和抗体分别增加了 55 倍和 37 倍。体液反应对原始 SARS-CoV-2 的强度最高，其次是 delta，然后是 omicron BA.2 和 BA.1 变体。两组的 T 细胞产生的干扰素-γ均增加了约 10 倍。
两剂 BBIBP-CorV 后给予一剂异源 Ad26.COV2.S 增强剂耐受性良好，并在两组的第 28 天均诱导了强烈的体液和细胞介导免疫应答。
NCT05109559。
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