<br>Advax-CpG 佐剂重组刺突蛋白疫苗 SpikoGen® 能够诱导针对 SARS-CoV-2 变体的交叉中和抗体,Immunology

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Advax-CpG 佐剂重组刺突蛋白疫苗 SpikoGen® 能够诱导针对 SARS-CoV-2 变体的交叉中和抗体
Immunology ( IF 4.9 ) Pub Date : 2023-05-18 , DOI: 10.1111/imm.13661
Yoshikazu Honda-Okubo _{1,

2} , Anna Antipov ₁ , Greiciely Andre ₁ , Saghar Barati ₃ , Hamidreza Kafi ₃ , Nikolai Petrovsky ₁

Affiliation

SpikoGen® 疫苗是一种在昆虫细胞中表达的亚单位 COVID-19 疫苗，由重组刺突蛋白胞外结构域组成，由 Advax-CpG55.2™ 佐剂配制。在 400 名成年参与者中进行了一项 2 期试验，他们以 3：1 的比例随机接受两次肌内注射 SpikoGen® 疫苗或生理盐水安慰剂，间隔 3 周。一些 2 期试验参与者后来参加了一项单独的加强研究，并接受了第三剂 SpikoGen® 疫苗。这种储存的血清用于评估 SpikoGen® 疫苗诱导针对相关 SARS-CoV-2 变体的交叉中和抗体的能力。使用一组刺突假型慢病毒中和测定法评估基线血清阴性 2 期受试者在基线和第二剂疫苗后 2 周采集的血清，以评估交叉中和多种 SARS-CoV-2 变体的能力，包括 Omicron BA.1、BA.2 和 BA.4/5。还分析了参与 2 剂 2 期试验和 6 个月后第三剂加强试验的受试者的储存样本，以了解交叉中和抗体随时间和剂量的变化。第二剂接种两周后，血清广泛交叉中和了大多数值得关注的变体，尽管针对 Omicron 变体的滴度降低了 ~10 倍。虽然大多数受试者在接种第二剂疫苗后 6 个月降至低水平，但在第三剂加强剂后，奥密克戎滴度上升了 ~20 倍，之后奥密克戎和祖先毒株的中和作用只有 ~2-3 倍的差异。尽管基于祖先的武汉序列，但在接种两剂后，SpikoGen® 疫苗诱导了广泛的交叉中和血清抗体。然后滴度随着时间的推移而降低，但通过第三剂加强剂迅速恢复。这导致了包括针对 Omicron 变体在内的高中和作用。这些数据支持持续使用 SpikoGen® 疫苗来预防最近的 SARS-CoV-2 Omicron 变体。

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Ability of SpikoGen®, an Advax-CpG adjuvanted recombinant spike protein vaccine, to induce cross-neutralising antibodies against SARS-CoV-2 variants

SpikoGen® vaccine is a subunit COVID-19 vaccine expressed in insect cells comprising recombinant spike protein extracellular domain formulated with Advax-CpG55.2™ adjuvant. A Phase 2 trial was conducted in 400 adult participants randomised 3:1 to receive two intramuscular doses of SpikoGen® vaccine or saline placebo 3 weeks apart. Some Phase 2 trial participants later enrolled in a separate booster study and received a third dose of SpikoGen® vaccine. This stored serum was used to assess the ability of SpikoGen® vaccine to induce cross-neutralising antibodies against SARS-CoV-2 variants of concern. Sera taken at baseline and 2 weeks after the second vaccine dose from baseline seronegative Phase 2 subjects was evaluated using a panel of spike pseudotype lentivirus neutralisation assays for the ability to cross-neutralise a wide range of SARS-CoV-2 variants, including Omicron BA.1, BA.2 and BA.4/5. Stored samples of subjects who participated in both the 2-dose Phase 2 trial and a third dose booster trial 6 months later were also analysed for changes in cross-neutralising antibodies over time and dose. Two weeks after the second dose, sera broadly cross-neutralised most variants of concern, albeit with titres against Omicron variants being ~10-fold lower. While Omicron titres fell to low levels 6 months after the second vaccine dose in most subjects, they showed a ~20-fold rise after the third dose booster, after which there was only a ~2-3-fold difference in neutralisation of Omicron and the ancestral strains. Despite being based on the ancestral Wuhan sequence, after two doses, SpikoGen® vaccine induced broadly cross-neutralising serum antibodies. Titres then reduced over time but were rapidly restored by a third dose booster. This resulted in high neutralisation including against the Omicron variants. This data supports ongoing use of SpikoGen® vaccine for protection against recent SARS-CoV-2 Omicron variants.

更新日期：2023-05-18

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