Standard
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. / 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.
в:
Frontiers in Immunology, Том 16, 1487039, 20.03.2025.
Результаты исследований: Научные публикации в периодических изданиях › статья › Рецензирование
Harvard
Logunov, DY, Dolzhikova, IV, Boiro, MY, Kovyrshina, AV, Dzharullaeva, AS, Erokhova, AS, Grousova, DM, Tukhvatulin, AI, Izhaeva, FM, Simakova, YV, Ordzhonikidze, MK, Lubenets, NL, Zubkova, OV, Scheblyakov, DV, Esmagambetov, IB, Shmarov, MM, Semikhin, AS, Tukhvatulina, NM, Shcherbinin, DN, Tutykhina, IL, Prokhorov, GS, Khovaev, AA, Demidova, TN, Malishev, NA, Merkulova, LN, Voronina, OL, Fedyakina, IT, Kisteneva, LB, Kolobukhina, LV, Mishin, DV, Elakov, AL, Ermolova, EI, Krasnoslobodtsev, KG, Larichev, VF, Kruzhkova, IS, Burmistrov, EM, Sheremet, AB, Tokarskaya, EA, Gromov, AV, Reshetnikov, DA, Fisun, AI, Kotiv, BN, Ovchinnikov, DV, Ivchenko, EV
, Zhdanov, KV, Zakharenko, SM, Solovev, AN, Ivanov, AM, Sukachev, VS, Gudkov, RV, Maltsev, OV, Gabdrakhmanov, IA, Barsukov, AV, Vashchenkov, VV, Demianenko, NI, Ignatev, SB, Asiamov, KV, Kirichenko, NN, Liubimov, AV, Volkov, II, Kriukov, EV, Bazarnov, NK, Kolodiazhnaia, VA, Kolomoets, EV, Syromyatnikova, SI, Chifanov, DE, Andrus, AF, Kutaev, DA, Borisevich, SV, Naroditsky, BS & Gintsburg, AL 2025, '
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',
Frontiers in Immunology, Том. 16, 1487039.
https://doi.org/10.3389/fimmu.2025.1487039,
https://doi.org/10.3389/fimmu.2025.1487039APA
Logunov, D. Y., Dolzhikova, I. V., Boiro, M. Y., Kovyrshina, A. V., Dzharullaeva, A. S., Erokhova, A. S., Grousova, D. M., Tukhvatulin, A. I., Izhaeva, F. M., Simakova, Y. V., Ordzhonikidze, M. K., Lubenets, N. L., Zubkova, O. V., Scheblyakov, D. V., Esmagambetov, I. B., Shmarov, M. M., Semikhin, A. S., Tukhvatulina, N. M., Shcherbinin, D. N., ... Gintsburg, A. L. (2025).
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.
Frontiers in Immunology,
16, [1487039].
https://doi.org/10.3389/fimmu.2025.1487039,
https://doi.org/10.3389/fimmu.2025.1487039Vancouver
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. /
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. в:
Frontiers in Immunology. 2025 ; Том 16.
BibTeX
@article{8a90cbff5c804789a4e2c4e36324f7a3,
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",
abstract = "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).CONCLUSION: 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.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT03072030; Pan African Clinical Trial Registry, identifier PACTR201702002053400.",
keywords = "Adolescent, Adult, Antibodies, Neutralizing/blood, Antibodies, Viral/blood, Double-Blind Method, Ebola Vaccines/immunology, Ebolavirus/immunology, Female, Guinea, Hemorrhagic Fever, Ebola/prevention & control, Humans, Immunity, Humoral, Immunogenicity, Vaccine, Male, Middle Aged, Russia, Vaccination, Young Adult, Ebola vaccine, rAd5, clinical trials, vector vaccine, EVD, rVSV, prime-boost",
author = "Logunov, {Denis Y.} and Dolzhikova, {Inna V.} and Boiro, {Mamadou Y.} and Kovyrshina, {Anna V.} and Dzharullaeva, {Alina S.} and Erokhova, {Alina S.} and Grousova, {Daria M.} and Tukhvatulin, {Amir I.} and Izhaeva, {Fatima M.} and Simakova, {Yana V.} and Ordzhonikidze, {Maria K.} and Lubenets, {Nadezhda L.} and Zubkova, {Olga V.} and Scheblyakov, {Dmitrii V.} and Esmagambetov, {Ilias B.} and Shmarov, {Maksim M.} and Semikhin, {Alexander S.} and Tukhvatulina, {Natalia M.} and Shcherbinin, {Dmitrii N.} and Tutykhina, {Irina L.} and Prokhorov, {Georgiy S.} and Khovaev, {Alexander A.} and Demidova, {Tatiana N.} and Malishev, {Nikolai A.} and Merkulova, {Liliya N.} and Voronina, {Olga L.} and Fedyakina, {Irina T.} and Kisteneva, {Lidiya B.} and Kolobukhina, {Lyudmila V.} and Mishin, {Dmitry V.} and Elakov, {Aleksandr L.} and Ermolova, {Ekaterina I.} and Krasnoslobodtsev, {Kirill G.} and Larichev, {Viktor F.} and Kruzhkova, {Irina S.} and Burmistrov, {Egor M.} and Sheremet, {Anna B.} and Tokarskaya, {Elizaveta A.} and Gromov, {Alexander V.} and Reshetnikov, {Dmitrii A.} and Fisun, {Aleksandr I.} and Kotiv, {Bogdan N.} and Ovchinnikov, {Dmitrii V.} and Ivchenko, {Evgenii V.} and Zhdanov, {Konstantin V.} and Zakharenko, {Sergei M.} and Solovev, {Aleksandr N.} and Ivanov, {Andrei M.} and Sukachev, {Vitalii S.} and Gudkov, {Roman V.} and Maltsev, {Oleg V.} and Gabdrakhmanov, {Ilnur A.} and Barsukov, {Anton V.} and Vashchenkov, {Vladislav V.} and Demianenko, {Nikolai I.} and Ignatev, {Sergei B.} and Asiamov, {Konstantin V.} and Kirichenko, {Nikolai N.} and Liubimov, {Andrei V.} and Volkov, {Igor I.} and Kriukov, {Evgenii V.} and Bazarnov, {Nikolai K.} and Kolodiazhnaia, {Viktoriia A.} and Kolomoets, {Elena V.} and Syromyatnikova, {Svetlana I.} and Chifanov, {Dmitry E.} and Andrus, {Alexander F.} and Kutaev, {Dmitry A.} and Borisevich, {Sergei V.} and Naroditsky, {Boris S.} and Gintsburg, {Alexander L.}",
year = "2025",
month = mar,
day = "20",
doi = "10.3389/fimmu.2025.1487039",
language = "English",
volume = "16",
journal = "Frontiers in Immunology",
issn = "1664-3224",
publisher = "Frontiers Media S.A.",
}
RIS
TY - JOUR
T1 - 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
AU - Logunov, Denis Y.
AU - Dolzhikova, Inna V.
AU - Boiro, Mamadou Y.
AU - Kovyrshina, Anna V.
AU - Dzharullaeva, Alina S.
AU - Erokhova, Alina S.
AU - Grousova, Daria M.
AU - Tukhvatulin, Amir I.
AU - Izhaeva, Fatima M.
AU - Simakova, Yana V.
AU - Ordzhonikidze, Maria K.
AU - Lubenets, Nadezhda L.
AU - Zubkova, Olga V.
AU - Scheblyakov, Dmitrii V.
AU - Esmagambetov, Ilias B.
AU - Shmarov, Maksim M.
AU - Semikhin, Alexander S.
AU - Tukhvatulina, Natalia M.
AU - Shcherbinin, Dmitrii N.
AU - Tutykhina, Irina L.
AU - Prokhorov, Georgiy S.
AU - Khovaev, Alexander A.
AU - Demidova, Tatiana N.
AU - Malishev, Nikolai A.
AU - Merkulova, Liliya N.
AU - Voronina, Olga L.
AU - Fedyakina, Irina T.
AU - Kisteneva, Lidiya B.
AU - Kolobukhina, Lyudmila V.
AU - Mishin, Dmitry V.
AU - Elakov, Aleksandr L.
AU - Ermolova, Ekaterina I.
AU - Krasnoslobodtsev, Kirill G.
AU - Larichev, Viktor F.
AU - Kruzhkova, Irina S.
AU - Burmistrov, Egor M.
AU - Sheremet, Anna B.
AU - Tokarskaya, Elizaveta A.
AU - Gromov, Alexander V.
AU - Reshetnikov, Dmitrii A.
AU - Fisun, Aleksandr I.
AU - Kotiv, Bogdan N.
AU - Ovchinnikov, Dmitrii V.
AU - Ivchenko, Evgenii V.
AU - Zhdanov, Konstantin V.
AU - Zakharenko, Sergei M.
AU - Solovev, Aleksandr N.
AU - Ivanov, Andrei M.
AU - Sukachev, Vitalii S.
AU - Gudkov, Roman V.
AU - Maltsev, Oleg V.
AU - Gabdrakhmanov, Ilnur A.
AU - Barsukov, Anton V.
AU - Vashchenkov, Vladislav V.
AU - Demianenko, Nikolai I.
AU - Ignatev, Sergei B.
AU - Asiamov, Konstantin V.
AU - Kirichenko, Nikolai N.
AU - Liubimov, Andrei V.
AU - Volkov, Igor I.
AU - Kriukov, Evgenii V.
AU - Bazarnov, Nikolai K.
AU - Kolodiazhnaia, Viktoriia A.
AU - Kolomoets, Elena V.
AU - Syromyatnikova, Svetlana I.
AU - Chifanov, Dmitry E.
AU - Andrus, Alexander F.
AU - Kutaev, Dmitry A.
AU - Borisevich, Sergei V.
AU - Naroditsky, Boris S.
AU - Gintsburg, Alexander L.
PY - 2025/3/20
Y1 - 2025/3/20
N2 - 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).CONCLUSION: 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.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT03072030; Pan African Clinical Trial Registry, identifier PACTR201702002053400.
AB - 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).CONCLUSION: 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.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT03072030; Pan African Clinical Trial Registry, identifier PACTR201702002053400.
KW - Adolescent
KW - Adult
KW - Antibodies, Neutralizing/blood
KW - Antibodies, Viral/blood
KW - Double-Blind Method
KW - Ebola Vaccines/immunology
KW - Ebolavirus/immunology
KW - Female
KW - Guinea
KW - Hemorrhagic Fever, Ebola/prevention & control
KW - Humans
KW - Immunity, Humoral
KW - Immunogenicity, Vaccine
KW - Male
KW - Middle Aged
KW - Russia
KW - Vaccination
KW - Young Adult
KW - Ebola vaccine
KW - rAd5
KW - clinical trials
KW - vector vaccine
KW - EVD
KW - rVSV
KW - prime-boost
UR - https://www.mendeley.com/catalogue/c47e476f-ab50-3304-bb94-d1119d03c888/
U2 - 10.3389/fimmu.2025.1487039
DO - 10.3389/fimmu.2025.1487039
M3 - Article
C2 - 40207235
VL - 16
JO - Frontiers in Immunology
JF - Frontiers in Immunology
SN - 1664-3224
M1 - 1487039
ER -
