对SpikoGen®的临床开发,这是Advax-CpG55.2辅助的复合尖蛋白疫苗
1Research Department, Australian Respiratory and Sleep Medicine Institute Ltd, Adelaide, Australia.
Human vaccines & immunotherapeutics
|June 5, 2024
概括
一种重组蛋白质疫苗SpikoGen®有效地保护人免受COVID-19变种的感染,包括三角洲菌株. 这种安全可靠的疫苗已被授权用于成人和儿童,正在开发一种增强剂版本.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 免疫学 免疫学 免疫学
- 病毒学 病毒学
背景情况:
- 再组合蛋白质疫苗为流行病准备提供了一个安全可靠的平台.
- 基于尖端蛋白质的疫苗是对抗SARS-CoV-2的关键策略.
- 辅助剂可以增强疫苗的免疫性和疗效.
研究的目的:
- 为了评估SpikoGen®的疗效和安全性,这是一个重组尖蛋白疫苗.
- 为了评估SpikoGen®对SARS-CoV-2变种的保护.
- 为了支持不同年龄组的SpikoGen®的监管批准.
主要方法:
- 开发SpikoGen®,一种在昆虫细胞中产生的重组尖蛋白修剪剂.
- 使用Advax-CpG55.2作为辅助剂的SpikoGen®的配方.
- 在多种动物模型 (老鼠,仓鼠,,非人类灵长类动物) 上进行临床前研究.
- 第3期安慰剂控制的疗效试验,共16876名参与者.
主要成果:
- 在临床前研究中对SARS-CoV-2变体进行一致的保护.
- 在3期试验中,在预防感染和严重疾病的Delta菌株方面显著的有效性.
- 伊朗食品和药物管理局授予的营销许可证,用于成人,随后用于5岁以上的儿童.
结论:
- 斯皮科基因 (SpikoGen®) 证明了对COVID-19的强有力的保护,包括变种.
- 辅助型基于蛋白质的疫苗方法对于疫情应对非常有价值.
- 斯皮科GEN®的成功开发和部署突显了平台对未来流行病的好处.
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