利比里亚公共卫生应对措施中 rVSVΔG-ZEBOV-GP 作为部分内容的 PREVAIL I 群疫苗接种研究。
PREVAIL I Cluster Vaccination Study With rVSVΔG-ZEBOV-GP as Part of a Public Health Response in Liberia.
机构信息
National Public Health Institute of Liberia, Monrovia, Liberia.
Division of Biostatistics, University of Minnesota, Minneapolis.
出版信息
J Infect Dis. 2019 Apr 19;219(10):1634-1641. doi: 10.1093/infdis/jiy698.
OBJECTIVE
In November 2015, a 15-year-old boy received a diagnosis of Ebola virus disease (EVD) at the John F. Kennedy Medical Center in Monrovia, Liberia. Two additional family members received a diagnosis of EVD. The protocol for a phase 2 placebo-controlled trial of 2 Ebola vaccines was amended and approved; in 4 days, a single-arm cluster vaccination trial using the Merck rVSVΔG-ZEBOV-GP vaccine was initiated. Here, we evaluate the safety and immunogenicity of the vaccine and discuss challenges for its implementation in a small Ebola outbreak.
METHOD
We conducted a ring vaccination study among contacts and contacts of close contacts of EVD cases a in Monrovia. Participants were evaluated 1 and 6 months after vaccination.
RESULTS
Among 650 close contacts and contacts of close contacts of EVD cases, 210 (32%) consented and were vaccinated with rVSVΔG-ZEBOV-GP. Of those vaccinated, 189 (90%) attended the month 1 follow-up visit; 166 (79%) attended the month 6 visit. No serious adverse events were reported. Among 88 participants without an elevated antibody level at baseline, 77.3% (95% confidence interval, 68.5-86.1) had an antibody response at 1 month.
CONCLUSIONS
The Merck rVSVΔG-ZEBOV-GP vaccine appeared to be safe and immunogenic among the vaccinated individuals. However, fewer than one third of eligible individuals consented to vaccination. These data may help guide implementation decisions for of cluster vaccination programs in an Ebola cluster outbreak response situation.
目的
2015 年 11 月，一名 15 岁男孩在利比里亚蒙罗维亚的约翰·肯尼迪医疗中心被诊断患有埃博拉病毒病（EVD）。另外两名家庭成员被诊断患有 EVD。修改并批准了两项埃博拉疫苗的 2 期安慰剂对照试验方案；在 4 天内，使用默克公司的 rVSVΔG-ZEBOV-GP 疫苗启动了一项单臂群组疫苗接种试验。在此，我们评估了该疫苗的安全性和免疫原性，并讨论了在小型埃博拉疫情中实施该疫苗的挑战。
方法
我们在蒙罗维亚的 EVD 病例的接触者及其密切接触者中进行了环疫苗接种研究。参与者在接种后 1 个月和 6 个月进行评估。
结果
在 650 名 EVD 病例的密切接触者及其密切接触者中，有 210 人（32%）同意并接种了 rVSVΔG-ZEBOV-GP。其中，189 人（90%）参加了第 1 个月的随访；166 人（79%）参加了第 6 个月的随访。未报告严重不良事件。在 88 名基线时抗体水平未升高的参与者中，77.3%（95%置信区间，68.5-86.1）在 1 个月时产生了抗体反应。
结论
默克公司的 rVSVΔG-ZEBOV-GP 疫苗在接种者中似乎是安全且具有免疫原性的。然而，只有不到三分之一的符合条件的人同意接种疫苗。这些数据可能有助于指导在埃博拉疫情爆发情况下进行群组疫苗接种计划的实施决策。
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