Clinical Development, Dynavax Technologies, 2100 Powell St, Emeryville, CA 94608, USA.
Department of Research and Evaluation, Kaiser Permanente Southern California, 100 S Los Robles Ave, Pasadena, CA 91101, USA.
Vaccine. 2021 Sep 15;39(39):5666-5672. doi: 10.1016/j.vaccine.2021.07.100. Epub 2021 Aug 14.
In the absence of field efficacy studies, estimating the real-world effectiveness of vaccines may consider immunogenicity from randomized controlled clinical trials and real-world adherence. Combining seroprotection rates (SPRs) with regimen completion rates gives an estimate of an effective vaccine protection rate (eVPR), which can be leveraged to evaluate real-world cost-effectiveness by linking it with vaccine costs to estimate the cost-per-protected patient (CPP).
This study evaluated eVPR and CPP as estimates of vaccine clinical- and cost-effectiveness of two-dose (HepB-CpG) and three-dose (HepB-Alum) hepatitis B virus (HBV) vaccines in the general adult population and a subpopulation with diabetes mellitus. eVPR was calculated from head-to-head SPR data from phase 3 clinical trials directly comparing HepB-CpG and HepB-Alum vaccine regimens and real-world head-to-head adherence data. CPP was calculated as the average cost of each regimen divided by eVPR.
Higher eVPR in the adult population was achieved with HepB-CpG (68.0%) versus HepB-Alum (41.6%), reflecting the combination of higher SPR and vaccine regimen completion. The CPP for HepB-CpG ($331.31) was $45.67 (95% CI: $36.66, $55.19) less than HepB-Alum ($377.09). Greater savings were observed among persons with diabetes, with CPP $149.60 (95% CI: $80.29, $195.63) lower with HepB-CpG ($367.57) than HepB-Alum ($517.37).
Metrics estimating vaccine real-world effectiveness and value may guide informed decisions in vaccine selection. For example, using eVPR and CPP, HepB-CpG represents a more effective, value-advantaged approach than HepB-Alum toward reducing HBV infection.
在缺乏现场疗效研究的情况下，估计疫苗的真实世界效果可以考虑来自随机对照临床试验的免疫原性和真实世界的依从性。将血清保护率（SPR）与方案完成率相结合，可以得出有效疫苗保护率（eVPR）的估计值，通过将其与疫苗成本联系起来估计每保护一个患者的成本（CPP），可以利用它来评估真实世界的成本效益。
本研究评估了两种剂量（HepB-CpG）和三种剂量（HepB-Alum）乙型肝炎病毒（HBV）疫苗在普通成年人群和糖尿病患者亚群中的两剂量（HepB-CpG）和三剂量（HepB-Alum）疫苗的临床和成本效益的 eVPR 和 CPP。eVPR 是通过直接比较 HepB-CpG 和 HepB-Alum 疫苗方案的 3 期临床试验的头对头 SPR 数据和真实世界的头对头依从性数据计算得出的。CPP 是通过将每种方案的平均成本除以 eVPR 计算得出的。
在成年人群中，HepB-CpG （68.0%）比 HepB-Alum （41.6%）实现了更高的 eVPR，这反映了更高的 SPR 和疫苗方案完成率的结合。HepB-CpG 的 CPP（331.31 美元）比 HepB-Alum （377.09 美元）低 45.67 美元（95%CI：36.66，55.19）。在糖尿病患者中观察到更大的节省，HepB-CpG 的 CPP（367.57 美元）比 HepB-Alum （517.37 美元）低 149.60 美元（95%CI：80.29，195.63）。
估计疫苗真实世界效果和价值的指标可以指导疫苗选择的决策。例如，使用 eVPR 和 CPP，HepB-CpG 比 HepB-Alum 更有效地降低 HBV 感染，具有更高的价值优势。
