Safety and immunogenicity of rVSVΔG-ZEBOV-GP Ebola vaccine in adults and children in Lambaréné, Gabon: A phase I randomised trial

1. World Health Organization Regional Office for Africa. WHO declares the end of the most recent Ebola virus disease outbreak in Liberia. Brazzaville (Republic of the Congo): World Health Organization Regional Office for Africa; 2016 Jun 9 [cited 2017 Sep 12]. Available from: http://www.afro.who.int/news/who-declares-end-most-recent-ebola-virus-disease-outbreak-liberia-0.

2. World Health Organization. Ebola situation report—30 March 2016. Geneva: World Health Organization; 2016 [cited 2016 Apr 29]. Available from: http://apps.who.int/ebola/current-situation/ebola-situation-report-30-march-2016.

3. World Health Organization. Ebola outbreak 2014–2015. Geneva: World Health Organization; 2016 [cited 2017 Mar 1]. Available from: http://who.int/csr/disease/ebola/en/.

4. Sridhar S. Clinical development of Ebola vaccines. Ther Adv vaccines. 2015;3(5–6):125–38. doi: 10.1177/2051013615611017 26668751

5. Wang Y, Li J, Hu Y, Liang Q, Wei M, Zhu F. Ebola vaccines in clinical trial: the promising candidates. Hum Vaccin Immunother. 2017;13(1):153–68. doi: 10.1080/21645515.2016.1225637 27764560

6. World Health Organization. Essential medicines and health products: Ebola vaccines, therapies, and diagnostics. Geneva: World Health Organization; 2015 [cited 2017 Sep 12]. Available from: http://www.who.int/medicines/emp_ebola_q_as/en.

7. Regules JA, Beigel JH, Paolino KM, Voell J, Castellano AR, Munoz P, et al. A recombinant vesicular stomatitis virus Ebola vaccine. N Engl J Med. 2017;376(4):330–41. doi: 10.1056/NEJMoa1414216 25830322

8. Henao-Restrepo AM, Camacho A, Longini IM, Watson CH, Edmunds WJ, Egger M, 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 Ca Suffit!). Lancet. 2017;389(10068):505–18. doi: 10.1016/S0140-6736(16)32621-6 28017403

9. Agnandji ST, Huttner A, Zinser ME, Njuguna P, Dahlke C, Fernandes JF, et al. Phase 1 trials of rVSV Ebola vaccine in Africa and Europe. N Engl J Med. 2016;374(17):1647–60. doi: 10.1056/NEJMoa1502924 25830326

10. Huttner A, Dayer JA, Yerly S, Combescure C, Auderset F, Desmeules J, et al. 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(10):1156–66. doi: 10.1016/S1473-3099(15)00154-1 26248510

11. Becquart P, Wauquier N, Mahlakoiv T, Nkoghe D, Padilla C, Souris M, et al. High prevalence of both humoral and cellular immunity to Zaire ebolavirus among rural populations in Gabon. PLoS ONE. 2010;5(2):e9126. doi: 10.1371/journal.pone.0009126 20161740

12. Heffernan RT, Pambo B, Hatchett RJ, Leman PA, Swanepoel R, Ryder RW. Low seroprevalence of IgG antibodies to Ebola virus in an epidemic zone: Ogooue-Ivindo region, Northeastern Gabon, 1997. J Infect Dis. 2005;191(6):964–8. doi: 10.1086/427994 15717273

13. Merck. Merck statement on rVSV-EBOV (V920) inclusion in Guinea study. Kenilworth (New Jersey): Merck; 2015 Mar 13 [cited 2017 Sep 12]. Available from: http://www.mrknewsroom.com/news/ebola-newsroom/merck-statement-rvsv-ebov-v920-inclusion-guinea-study.

14. Merck. Merck statement on rVSV-EBOV (V920) inclusion in Sierra Leone Ebola trial. Kenilworth (New Jersey): Merck; 2015 Feb 16 [cited 2017 Sep 12]. Available from: http://www.mrknewsroom.com/news/ebola-newsroom/merck-statement-rvsv-ebov-v920-inclusion-sierra-leone-ebola-trial.

15. Krahling V, Becker D, Rohde C, Eickmann M, Eroglu Y, Herwig A, et al. Development of an antibody capture ELISA using inactivated Ebola Zaire Makona virus. Med Microbiol Immunol. 2016;205(2):173–83. doi: 10.1007/s00430-015-0438-6 26475282

16. R: a language and environment for statistical computing. Vienna: R Foundation; 2015 [cited 2016 Feb 2]. Available from: https://www.R-project.org.

17. Heymann DL, Chen L, Takemi K, Fidler DP, Tappero JW, Thomas MJ, et al. Global health security: the wider lessons from the west African Ebola virus disease epidemic. Lancet. 2015;385(9980):1884–901. doi: 10.1016/S0140-6736(15)60858-3 25987157

18. Moon S, Sridhar D, Pate MA, Jha AK, Clinton C, Delaunay S, et al. Will Ebola change the game? Ten essential reforms before the next pandemic. The report of the Harvard-LSHTM Independent Panel on the Global Response to Ebola. Lancet. 2015;386(10009):2204–21. doi: 10.1016/S0140-6736(15)00946-0 26615326

19. Pigott DM, Golding N, Mylne A, Huang Z, Henry AJ, Weiss DJ, et al. Mapping the zoonotic niche of Ebola virus disease in Africa. eLife. 2014;3:e04395. doi: 10.7554/eLife.04395 25201877

20. Kanapathipillai R, Henao Restrepo AM, Fast P, Wood D, Dye C, Kieny MP, et al. Ebola vaccine—an urgent international priority. N Engl J Med. 2014;371(24):2249–51. doi: 10.1056/NEJMp1412166 25289888

21. Henao-Restrepo AM, Longini IM, Egger M, Dean NE, Edmunds WJ, Camacho A, et al. Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial. Lancet. 2015;386(9996):857–66. doi: 10.1016/S0140-6736(15)61117-5 26248676

22. Tapia MD, Sow SO, Lyke KE, Haidara FC, Diallo F, Doumbia M, et al. Use of ChAd3-EBO-Z Ebola virus vaccine in Malian and US adults, and boosting of Malian adults with MVA-BN-Filo: a phase 1, single-blind, randomised trial, a phase 1b, open-label and double-blind, dose-escalation trial, and a nested, randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2016;16(1):31–42. doi: 10.1016/S1473-3099(15)00362-X 26546548

23. Medaglini D, Harandi AM, Ottenhoff TH, Siegrist CA, VSV-Ebovac Consortium. Ebola vaccine R&D: filling the knowledge gaps. Sci Transl Med. 2015;7(317):317ps24. doi: 10.1126/scitranslmed.aad3106 26659569

24. Ledgerwood JE. Use of low dose rVSV-ZEBOV: safety issues in a Swiss cohort. Lancet Infect Dis. 2015;15(10):1117–9. doi: 10.1016/S1473-3099(15)00222-4 26248511

25. Halperin SA, Arribas JR, Rupp R, Andrews CP, Chu L, Das R, 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(12):1789–98. doi: 10.1093/infdis/jix189 28549145

26. Institute of Medicine, Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines, Howard C, Howe C, Fineberg H, editors. Adverse effects of pertussis and rubella vaccines. Washington (DC): National Academies Press; 1994.

27. Tingle AJ, Mitchell LA, Grace M, Middleton P, Mathias R, MacWilliam L, et al. Randomised double-blind placebo-controlled study on adverse effects of rubella immunisation in seronegative women. Lancet. 1997;349(9061):1277–81. doi: 10.1016/S0140-6736(96)12031-6 9142061

28. Weibel RE, Stokes J Jr, Buynak EB, Hilleman MR. Rubella vaccination in adult females. N Engl J Med. 1969;280(13):682–5. doi: 10.1056/NEJM196903272801302 5250184

29. Huttner A, Combescure C, Grillet S, Haks MC, Quinten E, Modoux C, et al. A dose-dependent plasma signature of the safety and immunogenicity of the rVSV-Ebola vaccine in Europe and Africa. Sci Transl Med. 2017;9(385):eaaj1701. doi: 10.1126/scitranslmed.aaj1701 28404856

30. Dahlke C, Kasonta R, Lunemann S, Krahling V, Zinser ME, Biedenkopf N, et al. Dose-dependent T-cell dynamics and cytokine cascade following rVSV-ZEBOV immunization. EBioMedicine. 2017;19:107–18. doi: 10.1016/j.ebiom.2017.03.045 28434944

31. Miranda ME, Miranda NL. Reston ebolavirus in humans and animals in the Philippines: a review. J Infect Dis. 2011;204(Suppl 3):S757–60. doi: 10.1093/infdis/jir296 21987747