Gsell Pierre-Stéphane, Camacho Anton, Kucharski Adam J, Watson Conall H, Bagayoko Aminata, Nadlaou Séverine Danmadji, Dean Natalie E, Diallo Abdourahamane, Diallo Abdourahmane, Honora Djidonou A, Doumbia Moussa, Enwere Godwin, Higgs Elizabeth S, Mauget Thomas, Mory Diakite, Riveros Ximena, Oumar Fofana Thierno, Fallah Mosoka, Toure Alhassane, Vicari Andrea S, Longini Ira M, Edmunds W J, Henao-Restrepo Ana Maria, Kieny Marie Paule, Kéïta Sakoba
World Health Organization, Geneva, Switzerland.
Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.
Lancet Infect Dis. 2017 Dec;17(12):1276-1284. doi: 10.1016/S1473-3099(17)30541-8. Epub 2017 Oct 9.
In March, 2016, a flare-up of Ebola virus disease was reported in Guinea, and in response ring vaccination with the unlicensed rVSV-ZEBOV vaccine was introduced under expanded access, the first time that an Ebola vaccine has been used in an outbreak setting outside a clinical trial. Here we describe the safety of rVSV-ZEBOV candidate vaccine and operational feasibility of ring vaccination as a reactive strategy in a resource-limited rural setting.
Approval for expanded access and compassionate use was rapidly sought and obtained from relevant authorities. Vaccination teams and frozen vaccine were flown to the outbreak settings. Rings of contacts and contacts of contacts were defined and eligible individuals, who had given informed consent, were vaccinated and followed up for 21 days under good clinical practice conditions.
Between March 17 and April 21, 2016, 1510 individuals were vaccinated in four rings in Guinea, including 303 individuals aged between 6 years and 17 years and 307 front-line workers. It took 10 days to vaccinate the first participant following the confirmation of the first case of Ebola virus disease. No secondary cases of Ebola virus disease occurred among the vaccinees. Adverse events following vaccination were reported in 47 (17%) 6-17 year olds (all mild) and 412 (36%) adults (individuals older than 18 years; 98% were mild). Children reported fewer arthralgia events than adults (one [<1%] of 303 children vs 81 [7%] of 1207 adults). No severe vaccine-related adverse events were reported.
The results show that a ring vaccination strategy can be rapidly and safely implemented at scale in response to Ebola virus disease outbreaks in rural settings.
WHO, Gavi, and the World Food Programme.
2016年3月,几内亚报告了埃博拉病毒病疫情复发,作为应对措施,在扩大使用范围的情况下引入了未经许可的重组水疱性口炎病毒载体埃博拉疫苗(rVSV-ZEBOV)进行环围式疫苗接种,这是埃博拉疫苗首次在临床试验之外的疫情环境中使用。在此,我们描述rVSV-ZEBOV候选疫苗的安全性以及环围式疫苗接种作为一种应对策略在资源有限的农村地区的操作可行性。
迅速向相关当局寻求并获得了扩大使用范围和同情用药的批准。疫苗接种团队和冻干疫苗被空运至疫情发生地。确定了接触者环和接触者的接触者环,对已签署知情同意书的符合条件的个体进行疫苗接种,并在良好临床实践条件下随访21天。
2016年3月17日至4月21日期间,在几内亚的四个环围区域对1510人进行了疫苗接种,其中包括303名6至17岁的儿童和307名一线工作人员。在确认首例埃博拉病毒病病例后,用了10天时间为第一名参与者接种疫苗。疫苗接种者中未出现埃博拉病毒病二代病例。6至17岁的儿童中有47人(17%)报告了接种后不良事件(均为轻度),18岁以上的成年人中有412人(36%)报告了接种后不良事件(98%为轻度)。儿童报告的关节痛事件少于成年人(303名儿童中有1名[<1%],而1207名成年人中有81名[7%])。未报告与疫苗相关的严重不良事件。
结果表明,环围式疫苗接种策略可在农村地区迅速、安全地大规模实施,以应对埃博拉病毒病疫情。
世界卫生组织、全球疫苗免疫联盟和世界粮食计划署。