Veröffentlichung von Ergebnissen klinischer Studien

Die nachfolgenden Informationen und die entsprechenden Links zu den klinischen Daten erfüllen die Anforderungen der Artikel 71-73 der Heilmittelverordnung (HMV). Sie ergänzen die Informationen, die im Zusammenhang mit der schweizerischen Zulassung des Arzneimittels veröffentlicht wurden.

ERVEBO®

Ebola Zaire-Impfstoff (rVSVΔG-ZEBOV-GP, lebend), Injektionslösung

Eine Dosis (1 ml) enthält: Ebola-Zaire-Impfstoff (rVSVΔG-ZEBOV-GP^1,2 lebend, attenuiert) ≥72 Millionen PBE³

¹Rekombinantes Vesikuläres-Stomatitis-Virus (rVSV) Stamm Indiana, bei dem das Glykoprotein (G) der VSV-Virushülle entfernt und durch das Stamm Kikwit 1995-Oberflächenglykoprotein (GP) des Zaire-Ebola-Virus (ZEBOV) ersetzt wurde.
²Gezüchtet in Vero-Zellen
³PBE = Plaque-bildende Einheiten

Swissmedic Zulassungsnummer: 68358

Swissmedic Zulassungsdatum: 10. November 2021

Zulassungsstudien

Protocol 009 (P009)

Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) – ClinicalTrials.gov
NCT02344407 – P009

Publications:
Kennedy SB, Bolay F, Kieh M, Grandits G, Badio M, Ballou R, Eckes R, Feinberg M, Follmann D, Grund B, Gupta S, Hensley L, Higgs E, Janosko K, Johnson M, Kateh F, Logue J, Marchand J, Monath T, Nason M, Nyenswah T, Roman F, Stavale E, Wolfson J, Neaton JD, Lane HC; PREVAIL I Study Group. Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia. N Engl J Med. 2017 Oct 12;377(15):1438-1447. doi: 10.1056/NEJMoa1614067. PMID: 29020589; PMCID: PMC5705229.

Higgs ES, Dubey SA, Coller BAG, Simon JK, Bollinger L, Sorenson RA, Wilson B, Nason MC, Hensley LE. Accelerating Vaccine Development During the 2013-2016 West African Ebola Virus Disease Outbreak. Curr Top Microbiol Immunol. 2017;411:229-261. doi: 10.1007/82_2017_53. PMID: 28918539.

Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21. PMID: 28647166.

Grais RF, Kennedy SB, Mahon BE, Dubey SA, Grant-Klein RJ, Liu K, Hartzel J, Coller B, Welebob C, Hanson ME, Simon JK. Estimation of the correlates of protection of the rVSVΔG-ZEBOV-GP Zaire ebolavirus vaccine: a post-hoc analysis of data from phase 2/3 clinical trials. Lancet Microbe 2021; 2: e70–78

Protocol 010 (P010) and Protocol 018 (P018)

Registered with the Pan African Clinical Trials Registry http://www.pactr.org/,
number PACTR201503001057193 (P010: Part A, P018: Part B)

Publications:
Henao-Restrepo AM, Camacho A, Longini IM et al. Efficacy and effectiveness of an rVSV-vectored vaccine in preventing EVD: final results from the Guinea ring vaccination, open-label, cluster[1]randomized trial (Ebola Ça Suffit!). Lancet 2017; 389:505-18.

Henao-Restrepo AM, Longini IM, Egger M, et al. Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomized trial. Lancet 2015; 386: 857–66.

Ajelli M, Merler S, Fumanelli L, et al. Spatio-temporal dynamics of the Ebola epidemic in Guinea and implications for vaccination and disease elimination: a computational modeling analysis. BMC Med 2016; 14: 130.

Ebola ça suffit ring vaccination trial consortium. The ring vaccination trial: A novel cluster randomized controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola. BMJ. 2015;351:h3740

Juan-Giner A, Tchaton M, Jemmy JP, Soumah A, Boum Y, Faga EM, Cisse M, Grais RF. Safety of the rVSV ZEBOV vaccine against Ebola Zaire among frontline workers in Guinea. Vaccine. 2019 Nov 15;37(48):7171-7177. doi: 10.1016/j.vaccine.2018.09.009. Epub 2018 Sep 25. PMID: 30266489.

Grantz KH, Claudot P, Kambala M, Kouyaté M, Soumah A, Boum Y, Juan-Giner A, Jemmy JP, Cummings DAT, Grais RF. Factors influencing participation in an Ebola vaccine trial among front-line workers in Guinea. Vaccine. 2019 Nov 15;37(48):7165-7170. doi: 10.1016/j.vaccine.2019.09.094. Epub 2019 Oct 14. PMID: 31623917.

Boum Y, Juan-Giner A, Hitchings M, Soumah A, Strecker T, Sadjo M, Cuthbertson H, Hayes P, Tchaton M, Jemmy JP, Clarck C, King D, Faga EM, Becker S, Halis B, Gunnstein N, Carroll M, Røttingen JA, Kondé MK, Doumbia M, Henao-Restrepo AM, Kieny MP, Cisse M, Draguez B, Grais RF. Humoral and cellular immune response induced by rVSVΔG-ZEBOV-GP vaccine among frontline workers during the 2013-2016 West Africa Ebola outbreak in Guinea. Vaccine. 2020 Jun 26;38(31):4877-4884. doi: 10.1016/j.vaccine.2020.04.066. Epub 2020 Jun 1. PMID: 32499066; PMCID: PMC7306162.

Protocol 011 (P011)

STRIVE (Sierra Leone Trial to Introduce a Vaccine Against Ebola) – ClinicalTrials.gov
NCT02378753 – P011

Publications:
Samai M, Seward JF, Goldstein ST, Mahon BE, Lisk DR, Widdowson MA, Jalloh MI, Schrag SJ, Idriss A, Carter RJ, Dawson P, Kargbo SAS, Leigh B, Bawoh M, Legardy-Williams J, Deen G, Carr W, Callis A, Lindblad R, Russell JBW, Petrie CR, Fombah AE, Kargbo B, McDonald W, Jarrett OD, Walker RE, Gargiullo P, Bash-Taqi D, Gibson L, Fofanah AB, Schuchat A; STRIVE Study Team. The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An Evaluation of rVSV∆G-ZEBOV-GP Vaccine Tolerability and Safety During the West Africa Ebola Outbreak. J Infect Dis. 2018 May 18;217(suppl_1):S6-S15. doi: 10.1093/infdis/jiy020. Erratum in: J Infect Dis. 2018 Jul 2;218(3):508-507.

Fombah AE, Goldstein ST, Jarrett OD, Jalloh MI, El-Khorazaty J, Lisk DR, Legardy-Williams J, Pratt DA, George PM, Russell JBW, Schrag SJ, Dawson P, Deen GF, Carr W, Lindblad R, James F, Bah MM, Yillia JF, Sandy JD, Turay PE, Conteh MA, Slutsker L, Mahon BE, Samai M, Seward JF. Health Conditions in an Adult Population in Sierra Leone: Data Reported From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE). J Infect Dis. 2018 May 18;217(suppl_1):S75-S80. doi: 10.1093/infdis/jix603.

Legardy-Williams JK, Carter RJ, Goldstein ST, Jarrett OD, Szefer E, Fombah AE, Tinker SC, Samai M, Mahon BE. Pregnancy Outcomes among Women Receiving rVSVΔ-ZEBOV-GP Ebola Vaccine during the Sierra Leone Trial to Introduce a Vaccine against Ebola. Emerg Infect Dis. 2020 Mar;26(3):541-548. doi: 10.3201/eid2603.191018. Epub 2020 Mar 17. PMID: 32017677; PMCID: PMC7045819.

Mahon BE, Simon J, Widdowson MA, Samai M, Rogier E, Legardy-Williams J, Liu K, Schiffer J, Lange J, DeByle C, Pinner R, Schuchat A, Slutsker L, Goldstein S. Baseline Asymptomatic Malaria Infection and Immunogenicity of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein. J Infect Dis. 2021 Dec 1;224(11):1907-1915. doi: 10.1093/infdis/jiab243. PMID: 34013349; PMCID: PMC8643414.

Widdowson MA, Schrag SJ, Carter RJ, Carr W, Legardy-Williams J, Gibson L, Lisk DR, Jalloh MI, Bash-Taqi DA, Kargbo SA, Idriss A, Deen GF, Russell JB, McDonald W, Albert AP, Basket M, Callis A, Carter VM, Ogunsanya KR, Gee J, Pinner R, Mahon BE, Goldstein ST, Seward JF, Samai M, Schuchat A. Implementing an Ebola Vaccine Study – Sierra Leone. MMWR Suppl. 2016 Jul 8;65(3):98-106. doi: 10.15585/mmwr.su6503a14. PMID: 27387395.

Conteh MA, Goldstein ST, Wurie HR, Gidudu J, Lisk DR, Carter RJ, Seward JF, Hampton LM, Wang D, Andersen LE, Arvay M, Schrag SJ, Dawson P, Fombah AE, Petrie CR, Feikin DR, Russell JBW, Lindblad R, Kargbo SAS, Samai M, Mahon BE. Clinical Surveillance and Evaluation of Suspected Ebola Cases in a Vaccine Trial During an Ebola Epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola. J Infect Dis. 2018 May 18;217(suppl_1):S33-S39. doi: 10.1093/infdis/jiy061. PMID: 29788347; PMCID: PMC6927893.

Protocol 012 (P012)

Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012) – ClinicalTrials.gov
NCT02503202 – P012

Publications:
Halperin SA, Arribas JR, Rupp R, Andrews CP, Chu L, Das R, Simon JK, Onorato MT, Liu K, Martin J, Helmond FA; V920-012 Study Team. 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 Jun 15;215(12):1789-1798. doi: 10.1093/infdis/jix189.

Halperin SA, Das R, Onorato MT, Liu K, Martin J, Grant-Klein RJ, Nichols R, Coller BA, Helmond FA, Simon JK; V920-012 Study Team. Immunogenicity, Lot Consistency, and Extended Safety of rVSVΔG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults. J Infect Dis. 2019 Aug 30;220(7):1127-1135. doi: 10.1093/infdis/jiz241.

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