94% of researchers rate our articles as excellent or good
Learn more about the work of our research integrity team to safeguard the quality of each article we publish.
Find out more
CLINICAL TRIAL article
Front. Immunol.
Sec. Vaccines and Molecular Therapeutics
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1487039
Safety and immunogenicity of GamEvac-Combi, a heterologous rVSVand rAd5-vectored Ebola vaccine: a randomized controlled multicenter clinical trial in the Republic of Guinea and Russia
Provisionally accepted
Denis Yurievich Logunov 1*
Inna Vadimovna Dolzhikova 1 Mamadou Yero Boiro 2
Anna Kovyrshina 1 Alina Shakhmirovna Dzharullaeva 1 Alina Sergeevna Erokhova 1 Daria Mikhailovna Grousova 1 Amir Ildarovich Tukhvatulin 1 Fatima Magometovna Izhaeva 1 Yana Vladimirovna Simakova 1 Maria Konstantinovna Ordzhonikidze 1 Nadezhda Leonidovna Lubenec 1 Olga Vadimovna Zubkova 1 Dmitrii Viktorovich Shcheblyakov 1
Ilias Bulatovich Esmagambetov 1 Maksim Mikhailovich Shmarov 1 Alexander Sergeevich Semikhin 1 Natalia Mikhailovna Tukhvatulina 1 Dmitrii Nikolaevich Shcherbinin 1 Irina Leonidovna Tutykhina 1 Georgiy Stepanovich Prokhorov 1 Alexander Alexandrovich Khovaev 1 Tatiana Nikolaevna Demidova 1 Nikolai Alexandrovich Malishev 1 Liliya Nikolaevna Merkulova 1
Olga Voronina 1 Irina Timofeevna Fedyakina 1 Lidiya Borisovna Kisteneva 1 Lyudmila Vasilievna Kolobukhina 1 Dmitry Vladimirovich Mishin 1 Aleksandr Leonidovich Elakov 1
Ekaterina Ivanovna Ermolova 1 Kirill Gennadievich Krasnoslobodtsev 1 Viktor Filippovich Larichev 1 Irina Sergeevna Kruzhkova 1 Egor Mikhailovich Burmistrov 1 Anna Borisovna Sheremet 1 Elizaveta Alexandrovna Tokarskaya 1 Alexander Viktorovich Gromov 1 Dmitrii Alexandrovich Reshetnikov 1 Aleksandr Yakovlevich Fisun 3 Bogdan Nikolaevich Kotiv 3 Dmitrij Valer'evich Ovchinnikov 3 Evgenij Viktorovich Ivchenko 3 Konstantin Valer'evich Zhdanov 3 Sergej Mixajlovich Zakharenko 3 Aleksandr Nikolaevich Solovev 3 Andrej Mixajlovich Ivanov 3 Vitalij Sergeevich Sukachev 3 Roman Vladimirivich Gudkov 3 Oleg Veniaminovich Maltsev 3 Ilnur Adisovich Gabdrahmanov 3 Anton Vladimirovich Barsukov 3 Vladislav Vyacheslavovich Vashchenkov 3 Nikolaj Yur'evich Demianenko 3 Sergej Borisovich Ignatev 3 Konstantin Valer'evich Asyamov 3 Nikolay Nikolaevich Kirichenko 3 Andrej Vladimirovic Lyubimov 3 Igor Ivanovich Volkov 3 Evgenij Vladimirovich Kryukov 3 Nikolay Konstantinovich Bazarnov 3 Victoria Anatolyevna Kolodyazhnaya 3 Elena Viktorovna Kolomoets 4 Sergei Vladimirovich Borisevich 5 Boris Savelievich Naroditsky 1 Alexander Leonidovich Gintsburg 1- 1 N.F. Gamalei Federal Research Centre for Epidemiology and Microbiology, Ministry of Health Russian Federation, Moscow, Russia
- 2 Research institute of Applied Biology of Guinea, Kindia, Guinea
- 3 Kirov Military Medical Academy, Saint Petersburg, Saint Petersburg, Russia
- 4 Medical service CBK RUSAL, Research Center for Epidemiology, Microbiology and Medical Care, Kindia, Guinea
- 5 48 Central Research Institute, Ministry of Defense, Sergiev Posad-6, Russia
Background: Ebola 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. Methods: 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.Results: 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.
Keywords: clinical trials, Vector vaccine, Evd, Ebola vaccine, Prime-boost, rVSV, rAd5 Clinical trial registration: ClinicalTrials.gov NCT03072030; Pan African Clinical Trial Registry PACTR201702002053400 без подчеркивания, Цвет шрифта: Авто отформатировано: Цвет шрифта: Текст 1 отформатировано: без подчеркивания
Received: 27 Aug 2024; Accepted: 19 Feb 2025.
Copyright: © 2025 Logunov, Dolzhikova, Boiro, Kovyrshina, Dzharullaeva, Erokhova, Grousova, Tukhvatulin, Izhaeva, Simakova, Ordzhonikidze, Lubenec, Zubkova, Shcheblyakov, Esmagambetov, Shmarov, Semikhin, Tukhvatulina, Shcherbinin, Tutykhina, Prokhorov, Khovaev, Demidova, Malishev, Merkulova, Voronina, Fedyakina, Kisteneva, Kolobukhina, Mishin, Elakov, Ermolova, Krasnoslobodtsev, Larichev, Kruzhkova, Burmistrov, Sheremet, Tokarskaya, Gromov, Reshetnikov, Fisun, Kotiv, Ovchinnikov, Ivchenko, Zhdanov, Zakharenko, Solovev, Ivanov, Sukachev, Gudkov, Maltsev, Gabdrahmanov, Barsukov, Vashchenkov, Demianenko, Ignatev, Asyamov, Kirichenko, Lyubimov, Volkov, Kryukov, Bazarnov, Kolodyazhnaya, Kolomoets, Borisevich, Naroditsky and Gintsburg. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Denis Yurievich Logunov, N.F. Gamalei Federal Research Centre for Epidemiology and Microbiology, Ministry of Health Russian Federation, Moscow, Russia
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.