Randomized Controlled Trial of the Immunogenicity and Safety of a Serum-Free Purified Vero Rabies Vaccine (PVRV-NG2) Using a Simulated Postexposure Zagreb Regimen With Human Rabies Immunoglobulin in Adults in Thailand.
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Abstract
Background: A serum-free, highly purified Vero rabies vaccine-next generation (PVRV-NG2) is under development. We conducted a phase III trial to describe the safety and immunogenicity profile of PVRV-NG2 compared with those of licensed purified Vero rabies vaccine (PVRV) in a simulated rabies postexposure prophylaxis (PEP) Zagreb regimen in Thailand.
Methods: Healthy adults aged ≥18 years (n = 201) were randomized in a 2:1 ratio to receive PVRV-NG2 or PVRV in a rabies PEP Zagreb (days 0, 7, 21 [2-1-1]) regimen, with concomitant human rabies immunoglobulin (HRIG) at day 0. Immunogenicity end points included the proportion of participants with rabies virus-neutralizing antibody (RVNA) titers ≥0.5 IU/mL at days 0, 14, and 35. Safety outcomes were also assessed.
Results: A total of 199 participants completed the study (PVRV-NG2 n = 133, PVRV n = 66). In the PVRV-NG2 group and PVRV group, respectively, 91.0% (95% CI, 84.1%-95.6%) and 94.6% (95% CI, 85.1%-98.9%) had RVNA titers ≥0.5 IU/mL at day 14, increasing to 100% (95% CI, 96.8%-100%) and 100% (95% CI, 93.5%-100%) by day 35. The vaccines had similar safety profiles, and there were no safety concerns.
Conclusions: PVRV-NG2 showed acceptable safety and immunogenicity profiles when co-administered with HRIG in a simulated PEP Zagreb regimen in healthy adults in Thailand.
无血清纯化狂犬病疫苗（PVRV-NG2）的免疫原性和安全性随机对照试验--在泰国成人中使用人狂犬病免疫球蛋白的模拟暴露后萨格勒布疗法》（Randomized Controlled Trial of Immunogenicity and Safety of a Serum-Free Purified Vero Rabies Vaccine (PVRV-NG2) Using a Simulated Postexposure Zagreb Regimen with Human Rabies Immunoglobulin in Adults in Thailand）。
背景：一种无血清、高度纯化的下一代 Vero 狂犬病疫苗（PVRV-NG2）正在开发中。我们在泰国进行了一项 III 期试验，在模拟狂犬病暴露后预防 (PEP) 的萨格勒布方案中，比较 PVRV-NG2 与已获许可的纯化 Vero 狂犬病疫苗 (PVRV) 的安全性和免疫原性。方法：年龄≥18 岁的健康成人（n = 201）按 2:1 的比例随机接受 PVRV-NG2 或 PVRV 的狂犬病 PEP 萨格勒布方案（第 0、7、21 [2-1-1]天），第 0 天同时注射人狂犬病免疫球蛋白 (HRIG)。此外还评估了安全性结果：共有 199 名参与者完成了研究（PVRV-NG2 n = 133，PVRV n = 66）。在PVRV-NG2组和PVRV组中，第14天RVNA滴度≥0.5 IU/mL的分别为91.0%（95% CI，84.1%-95.6%）和94.6%（95% CI，85.1%-98.9%），第35天增至100%（95% CI，96.8%-100%）和100%（95% CI，93.5%-100%）。两种疫苗的安全性相似，没有安全性问题：结论：PVRV-NG2 与 HRIG 共同用于泰国健康成人的模拟 PEP Zagreb 方案时，显示出了可接受的安全性和免疫原性。
期刊介绍：
Open Forum Infectious Diseases provides a global forum for the publication of clinical, translational, and basic research findings in a fully open access, online journal environment. The journal reflects the broad diversity of the field of infectious diseases, and focuses on the intersection of biomedical science and clinical practice, with a particular emphasis on knowledge that holds the potential to improve patient care in populations around the world. Fully peer-reviewed, OFID supports the international community of infectious diseases experts by providing a venue for articles that further the understanding of all aspects of infectious diseases.
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