Objective: To review the clinical data regarding the safety and efficacy of the Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) vaccine for the prevention of the Ebola virus disease. Data Sources: A literature search through PubMed, MEDLINE, and Cochrane Library was conducted for clinical trials published between January 2014 and June 2020 in the English language using the keywords Ervebo, rVSVΔG-ZEBOV, rVSVΔG-ZEBOV-GP, Ebola Zaire, and vaccine. Study Selection and Data Extraction: Articles were selected if they were related to the Food and Drug Administration (FDA) approval of Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) or provided novel data regarding this entity. Twelve articles noted in the FDA approval were chosen, along with 2 additional articles identified as providing novel information. Data Synthesis: The findings of the review show that Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) is a safe, immunogenic, and likely effective vaccine for the prevention of Ebola virus disease. Relevance to Patient Care and Clinical Practice: Ebola virus disease is highly infectious and often fatal. There have been multiple large outbreaks in the past 5 years, with no licensed treatments or vaccines. An effective vaccine could largely curtail current outbreaks and prevent further ones. Conclusion: The recent FDA approval of Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) offers the first approved vaccine for the prevention of Ebola virus disease. It has been shown to be safe, immunogenic, and likely effective for use in real-world applications for those at risk of contracting the disease.
CollerBAGBlueJDasR, et al. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017;35(35pt A):4465-4469. doi:10.1016/j.vaccine.2017.05.097
3.
Centers for Disease Control and Prevention. Ebola (Ebola virus disease): what is Ebola virus disease?Accessed January 29, 2020. https://www.cdc.gov/vhf/ebola/about.html
4.
MilliganIDGibaniMMSewellR, et al. Safety and immunogenicity of novel adenovirus type 26- and modified vaccinia Ankara-vectored Ebola vaccines: a randomized clinical trial. JAMA. 2016;315:1610-1623. doi:10.1001/jama.2016.4218
HeppnerDGJrKempTLMartinBK, et al; V920-004 Study Team. Safety and immunogenicity of the rVSVΔG-ZEBOV-GP Ebola virus vaccine candidate in healthy adults: a phase 1b randomised, multicentre, double-blind, placebo-controlled, dose-response study. Lancet Inf Dis. 2017;17:854-866. doi:10.1016/S1473-3099(17)30313-4
8.
HuttnerADayerJAYerlyS, et al; VSV-Ebola Consortium. The effect of dose on the safety and immunogenicity of the VSV Ebola candidate vaccine: a randomised double-blind, placebo-controlled phase 1/2 trial. Lancet Infect Dis. 2015;15:1156-1166. doi:10.1016/S1473-3099(15)00154-1
9.
AgnandjiSTHuttnerAZinserME, et al. Phase 1 trials of rVSV Ebola vaccine in Africa and Europe. N Engl J Med. 2016;374:1647-1660. doi:10.1056/NEJMoa1502924
10.
RegulesJABeigelJHPaolinoKM, et al; rVSVΔG-ZEBOV-GP Study Group. A recombinant vesicular stomatitis virus Ebola vaccine. N Engl J Med. 2017;376:330-341. doi:10.1056/NEJMoa1414216
11.
ElSherifMSBrownCMacKinnon-CameronD, et al; Canadian Immunization Research Network. Assessing the safety and immunogenicity of recombinant vesicular stomatitis virus Ebola vaccine in healthy adults: a randomized clinical trial. CMAJ. 2017;189:E819-E827. doi:10.1503/cmaj.170074
12.
KennedySBBolayFKiehM, et al; PREVAIL I Study Group. Phase 2 placebo-controlled trial of two vaccines to prevent Ebola in Liberia. N Engl J Med. 2017;377:1438-1447. doi:10.1056/NEJMoa1614067
13.
SamaiMSewardJFGoldsteinST, et al; STRIVE Study Team. The Sierra Leone trial to introduce a vaccine against Ebola: an evaluation of rVSVΔG-ZEBOV-GP vaccine tolerability and safety during the West Africa Ebola outbreak. J Infect Dis. 2018;217(suppl 1):S6-S15. doi:10.1093/infdis/jiy020
14.
HalperinSAArribasJRRuppR, et al. Six-month safety data of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine in a phase 3 double-blind, placebo-controlled randomized study in healthy adults. J Infect Dis. 2017;215:1789-1798. doi:10.1093/infdis/jix189
15.
Henao-RestrapoAMCamachoALonginiIM, et al. Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!). Lancet. 2017;389:505-518. doi:10.1016/S0140-6736(16)32621-6
BolayFKGranditsGLaneHC, et al. PREVAIL I cluster vaccination study with rVSVΔG-ZEBOV-GP as part of a public health response in Liberia. J Infect Dis. 2019;219:1634-1641. doi:10.1093/infdis/jiy698
18.
RechtienARichertLLorenzoH, et al. Systems vaccinology identifies an early innate immune signature as a correlate of antibody responses to the Ebola vaccine rVSV-ZEBOV. Cell Rep. 2017;20:2251-2261. doi:10.1016/j.celrep.2017.08.023
19.
PoetschJHDahlkeCZinserME, et al. Detectable vesicular stomatitis virus (VSV)-specific humoral and cellular immune responses following VSV-Ebola virus vaccination in humans. J Infect Dis. 2019;219:556-561. doi:10.1093/infdis/jiy565
20.
EhrhardtSAZahnerMKrahlingV, et al. Polyclonal and convergent antibody response to Ebola virus vaccine rVSV-ZEBOV. Nat Med. 2019;25:1589-1600. doi:10.1038/s41591-019-0602-4
21.
RudgeTLJrSankovichKANiemuthNA, et al. Development, qualification, and validation of the Filovirus Animal Nonclinical Group anti-Ebola virus glycoprotein immunoglobulin G enzyme-linked immunosorbent assay for human serum samples. PLoS One. 2019;14:e0215457. doi:10.1371/journal.pone.0215457
22.
MetzgerWVivas-MartinezS.Questionable efficacy of the rVSV-ZEBOV Ebola vaccine. Lancet. 2018;391:1021. doi:10.1016/S0140-6736(18)30560-9
23.
US National Library of Medicine, ClinicalTrials.gov. African-Canadian study of HIV-infected adults and a vaccine for Ebola—ACHIV-Ebola. Published January 26, 2017. Accessed January 29, 2020. https://clinicaltrials.gov/ct2/show/results/NCT03031912
