首先没有伤害吗? 模拟C型肝炎疫苗开发挑战试验的风险和益处
Alyssa Bilinski1,2, Rachel Slimovitch3, Andrew Mendlowitz4
1Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island, USA.
概括
通过挑战试验,可以加快型肝炎病毒 (HCV) 疫苗的研发速度. 这些试验可以避免重大感染,与传统方法相比,提供有利的益处风险比率.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 传染病流行病学 传染病流行病学
- 临床试验设计 临床试验设计
背景情况:
- 在2019年,全球约有5800万人患有慢性肝炎C病毒 (HCV) 感染.
- 开发HCV疫苗是一个关键的公共卫生目标.
- 挑战性试验正在被探索,作为一种潜在的加速途径,用于HCV疫苗开发.
研究的目的:
- 通过使用C型肝炎病毒 (HCV) 挑战试验方法来模拟避免增量感染的数量.
- 为了比较挑战试验与传统疫苗开发方法的益处风险比率.
- 通过对治疗的挑战试验,比较预防感染的成本效益.
主要方法:
- 根据试验持续时间,候选人数量和疫苗接种的各种假设,避免增量感染的建模.
- 计算益处风险比率 (BRRs),比较传统试验方法的挑战.
- 与通过C型肝炎病毒 (HCV) 治疗获得类似益处的货币成本进行比较.
主要成果:
- 挑战方法可以避免额外的185,000到832,000个感染,这取决于疫苗接种率 (20%对90%).
- 经质量调整的生命年利风险比率在72,000至323,000之间.
- 通过治疗实现同等效益将至少花费9200万美元至4.16亿美元.
结论:
- 型肝炎病毒 (HCV) 挑战试验显示出加速疫苗开发的希望.
- 通过增加候选疫苗数量,试验速度和疫苗接种率,挑战方法的好处得到了放大.
- 挑战性试验为减少C型肝炎病毒 (HCV) 感染负担提供了潜在的成本效益战略.
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