AUTHOR=Logunov Denis Y. , Dolzhikova Inna V. , Boiro Mamadou Y. , Kovyrshina Anna V. , Dzharullaeva Alina S. , Erokhova Alina S. , Grousova Daria M. , Tukhvatulin Amir I. , Izhaeva Fatima M. , Simakova Yana V. , Ordzhonikidze Maria K. , Lubenets Nadezhda L. , Zubkova Olga V. , Scheblyakov Dmitrii V. , Esmagambetov Ilias B. , Shmarov Maksim M. , Semikhin Alexander S. , Tukhvatulina Natalia M. , Shcherbinin Dmitrii N. , Tutykhina Irina L. , Prokhorov Georgiy S. , Khovaev Alexander A. , Demidova Tatiana N. , Malishev Nikolai A. , Merkulova Liliya N. , Voronina Olga L. , Fedyakina Irina T. , Kisteneva Lidiya B. , Kolobukhina Lyudmila V. , Mishin Dmitry V. , Elakov Aleksandr L. , Ermolova Ekaterina I. , Krasnoslobodtsev Kirill G. , Larichev Viktor F. , Kruzhkova Irina S. , Burmistrov Egor M. , Sheremet Anna B. , Tokarskaya Elizaveta A. , Gromov Alexander V. , Reshetnikov Dmitrii A. , Fisun Aleksandr I. , Kotiv Bogdan N. , Ovchinnikov Dmitrii V. , Ivchenko Evgenii V. , Zhdanov Konstantin V. , Zakharenko Sergei M. , Solovev Aleksandr N. , Ivanov Andrei M. , Sukachev Vitalii S. , Gudkov Roman V. , Maltsev Oleg V. , Gabdrakhmanov Ilnur A. , Barsukov Anton V. , Vashchenkov Vladislav V. , Demianenko Nikolai I. , Ignatev Sergei B. , Asiamov Konstantin V. , Kirichenko Nikolai N. , Liubimov Andrei V. , Volkov Igor I. , Kriukov Evgenii V. , Bazarnov Nikolai K. , Kolodiazhnaia Viktoriia A. , Kolomoets Elena V. , Syromyatnikova Svetlana I. , Chifanov Dmitry E. , Andrus Alexander F. , Kutaev Dmitry A. , Borisevich Sergei V. , Naroditsky Boris S. , Gintsburg Alexander L. 

TITLE=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

JOURNAL=Frontiers in Immunology

VOLUME=Volume 16 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1487039

DOI=10.3389/fimmu.2025.1487039

ISSN=1664-3224

ABSTRACT=BackgroundEbola 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.MethodsA 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.ResultsVaccinated 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).ConclusionThe 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.Clinical trial registrationClinicalTrials.gov, identifier NCT03072030; Pan African Clinical Trial Registry, identifier PACTR201702002053400.