Safety and immunogenicity of GamEvac-Combi, a heterologous rVSV- and rAd5-vectored Ebola vaccine: a randomized controlled multicenter clinical trial in the Republic of Guinea and Russia
Author:
Logunov DYORCID, Dolzhikova ORCID, Boiro MY, Kovyrshina AVORCID, Dzharullaeva ASORCID, Erokhova ASORCID, Grousova DMORCID, Tukhvatulin AIORCID, Izhaeva FMORCID, Simakova YVORCID, Ordzhonikidze MK, Lubenets NLORCID, Zubkova OVORCID, Scheblyakov DVORCID, Esmagambetov IBORCID, Shmarov MMORCID, Semikhin ASORCID, Tukhvatulina NMORCID, Shcherbinin DNORCID, Tutykhina ILORCID, Prokhorov GS, Khovaev AA, Demidova TN, Malishev NA, Merkulova LN, Voronina OL, Fedyakina IT, Kisteneva LB, Kolobukhina LVORCID, Mishin DV, Elakov AL, Ermolova EI, Krasnoslobodtsev KGORCID, Larichev VF, Kruzhkova ISORCID, Burmistrov EMORCID, Sheremet ABORCID, Tokarskaya EA, Gromov AV, Reshetnikov DA, Fisun AY, Kotiv BN, Ovchinnikov DV, Ivchenko EV, Zhdanov KV, Zakharenko SM, Solovev AN, Ivanov AM, Sukachev VS, Gudkov RV, Maltsev OV, Gabdrahmanov IA, Barsukov AV, Vashchenkov VV, Demianenko NY, Ignatev SB, Asyamov KV, Kirichenko NN, Lyubimov AV, Volkov , Kryukov EV, Bazarnov NK, Kolodyazhnaya V, Kolomoets EV, Syromyatnikova SI, Chifanov DE, Andrus AF, Kutaev DA, Borisevich SV, Naroditsky BSORCID, Gintsburg ALORCID,
Abstract
AbstractEbola virus disease (EVD) is one of the most dangerous and lethal diseases affecting humans. There are several licensed vaccines against EVD, but it remains one of the priority diseases for research and development of effective vaccines. A double-blind randomized placebo-controlled trial was performed to evaluate safety and immunogenicity of rVSV- and rAd5-vectored vaccine “GamEvac-Combi” in healthy adults of both sexes between 18 and 60 years. Safety and immunogenicity were assessed during the observation period of 12 months. Immunogenicity was assessed with GP-specific ELISA, IFN-γ ELISA, and plaque pseudoneutralization assay. Vaccinated participants showed marked GP-specific IFN-γ response at day 28 and neutralizing response at day 42 (GMT = 32.6, seroconversion rate 96.3%). GP-specific IgG antibody levels in vaccinated participants peaked at day 42 (GMT = 9345) and persisted for a year after vaccination (GMT = 650). The vaccine showed favorable safety profile and induced robust cell-mediated immune response and strong humoral immune response that lasts at least for a year from the start of vaccination. The study was funded by the Ministry of Health of Russian Federation; GamEvac-CombiClinicalTrials.govnumber,NCT03072030, Pan African Clinical Trial Registry PACTR201702002053400.
Publisher
Cold Spring Harbor Laboratory
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