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刚果民主共和国采用rVSV-ZEBOV-GP环式疫苗接种应对埃博拉疫情

Ebola Outbreak Response in the DRC with rVSV-ZEBOV-GP Ring Vaccination.

作者信息

Muyembe Jean-Jacques, Pan Hongchao, Peto Richard, Diallo Abdourahamane, Touré Alhassane, Mbala-Kingebene Placide, Bateyi Mustafa Stéphane H, Tambwe Ndjoloko, Mulangu Sabue, Ahuka-Mundeke Steve, Mukamba Musenga Elisabeth, Enwere Godwin, Gsell Pierre-Stéphane, Longini Ira M, Riveros Balta Ximena, Roberts Chrissy H, Marks Michael, Yao Michel N K, Gueye Abdou Salam, Fall Ibrahima-Soce, Salama Peter, Ryan Michael J, Henao-Restrepo Ana Maria

机构信息

From the Institut National de Recherche Biomédicale and Faculté de Médecine, Université de Kinshasa (J.-J.M., P.M.-K., S.M., S.A.-M.), and the Ministry of Public Health (S.H.B.M., N.T., E.M.M.) - both in Kinshasa, Democratic Republic of Congo; the Nuffield Department of Population Health, University of Oxford, Oxford (H.P., R.P.), and the London School of Hygiene and Tropical Medicine, London (C.H.R., M.M.) - both in the United Kingdom; University of Florida, Gainesville (I.M.L.); and the World Health Organization, Geneva (A.D., A.T., G.E., P.-S.G., X.R.B., M.N.K.Y., A.S.G., I.-S.F., P.S., M.J.R., A.M.H.-R.).

出版信息

N Engl J Med. 2024 Dec 19;391(24):2327-2336. doi: 10.1056/NEJMoa1904387.

Abstract

BACKGROUND

At the beginning of the 2018-2020 outbreak of Ebola virus disease (EVD) in eastern Democratic Republic of Congo (DRC), no vaccine had been licensed. However, cluster-randomized evidence from Guinea in 2015 had indicated that ring vaccination around new cases (targeting contacts and contacts-of-contacts) with the use of single-dose live-replicating rVSV-ZEBOV-GP vaccine reduced EVD rates starting 10 days after vaccination. Thus, ring vaccination was added to the standard control measures for that outbreak.

METHODS

In this study, we evaluated the incidence of EVD within the first 9 days after vaccination (when little protection was expected from case isolation or ring vaccination), during days 10 to 29, and at later time periods. We established 1853 rings around new cases or clusters within 21 days after symptom onset in the index case and offered vaccination to the ring members. Vaccinees were monitored for EVD onset until the end of the outbreak in mid-2020.

RESULTS

From August 8, 2018, to January 14, 2020, we vaccinated 265,183 participants. Of these vaccinees, 102,515 were monitored on days 0, 3, and 21 for safety. Among the contacts and contacts-of-contacts, 434 cases of EVD (0.2 per ring) were diagnosed, almost all within 0 to 9 days (380 cases) or 10 to 29 days (32 cases) after vaccination. An additional 22 cases were diagnosed after day 29 during an average of 170 more days of follow-up. The sooner that control measures (including ring vaccination) began after EVD onset in the index case, the sooner EVD rates fell among contacts. In each subgroup, EVD rates fell suddenly around day 10. Among the contacts and contacts-of-contacts who were still disease-free at day 10, the EVD onset rate during days 10 to 29 was 0.16 per 1000 (in 32 of 194,019 participants). This rate was much lower than the rate of 4.64 per 1000 (in 21 of 4528 participants) that had been seen among similarly defined ring members in Guinea, in whom standard control measures had been promptly initiated but vaccination was delayed until 21 days after ring formation (rate ratio, 0.04; 95% confidence interval, 0.02 to 0.06). No safety concerns with the vaccine were identified.

CONCLUSIONS

Nonrandomized evidence regarding standard EVD control measures plus ring vaccination in eastern DRC reinforces the earlier randomized evidence from Guinea of vaccine efficacy against EVD onset 10 or more days after vaccination.

摘要

背景

在2018 - 2020年刚果民主共和国东部埃博拉病毒病(EVD)疫情爆发初期,尚无获批的疫苗。然而,2015年几内亚的整群随机试验证据表明,使用单剂量活复制型rVSV - ZEBOV - GP疫苗对新发病例周围(针对接触者及接触者的接触者)进行环式疫苗接种可降低接种10天后的埃博拉病毒病发病率。因此,环式疫苗接种被纳入该疫情的标准防控措施。

方法

在本研究中,我们评估了接种疫苗后第1个9天内(此时病例隔离或环式疫苗接种预期几乎没有保护作用)、第10至29天以及之后时间段内的埃博拉病毒病发病率。我们在首例病例症状出现后的21天内围绕新发病例或聚集性病例建立了1853个环,并为环内成员提供疫苗接种。对接种者进行埃博拉病毒病发病监测,直至2020年年中疫情结束。

结果

从2018年8月8日至2020年1月14日,我们为265,183名参与者接种了疫苗。其中102,515名接种者在第0、3和21天接受了安全性监测。在接触者及接触者的接触者中,确诊了434例埃博拉病毒病病例(每个环0.2例),几乎所有病例均在接种后0至9天(380例)或10至29天(32例)内。在接种后第29天之后的平均170多天随访期间又确诊了22例。首例病例出现埃博拉病毒病后,控制措施(包括环式疫苗接种)开始得越早,接触者中的埃博拉病毒病发病率下降得就越早。在每个亚组中,埃博拉病毒病发病率在第10天左右突然下降。在第10天仍未发病的接触者及接触者的接触者中,10至29天内的埃博拉病毒病发病率为每1000人中有0.16例(194,019名参与者中的32例)。该发病率远低于几内亚类似定义的环内成员中每1000人中有4.64例(4528名参与者中的21例)的发病率,在几内亚,标准防控措施已迅速启动,但疫苗接种推迟至环形成后21天(率比为0.04;95%置信区间为0.02至0.06)。未发现该疫苗存在安全性问题。

结论

关于刚果民主共和国东部标准埃博拉病毒病防控措施加环式疫苗接种的非随机证据,强化了几内亚早期的随机试验证据,即疫苗对接种10天及更长时间后的埃博拉病毒病发病具有疗效。

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