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1Academic Journal
Authors: O. Popova, O. V. Zubkova, T. A. Ozharovskaia, D. I. Zrelkin, D. V. Voronina, P. P. Goldovskaya, V. Yu. Kan, I. V. Dolzhikova, A. V. Kovyrshina, D. M. Grousova, I. A. Ermolova, D. V. Shcheblyakov, D. Yu. Logunov, A. L. Gintsburg, О. Попова, О. В. Зубкова, Т. А. Ожаровская, Д. И. Зрелкин, Д. В. Воронина, П. П. Голдовская, В. Ю. Кан, И. В. Должикова, А. В. Ковыршина, Д. М. Гроусова, И. А. Ермолова, Д. В. Щебляков, Д. Ю. Логунов, А. Л. Гинцбург
Contributors: Исследование выполнено в рамках Государственного задания Министерства здравоохранения Российской Федерации «Разработка вакцины для профилактики лихорадки Ласса»
Source: Medical Immunology (Russia); Том 27, № 1 (2025); 153-168 ; Медицинская иммунология; Том 27, № 1 (2025); 153-168 ; 2313-741X ; 1563-0625
Subject Terms: безопасность, vaccine, adenovirus vector, human adenovirus, immunogenicity, safety assessment, вакцина, рекомбинантный аденовирусный вектор, аденовирус человека, иммуногенность
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Relation: https://www.mimmun.ru/mimmun/article/view/2988/2078; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13695; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13696; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13697; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13698; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13699; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13700; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13701; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13702; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13703; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13704; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13705; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13838; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13839; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13840; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/13933; https://www.mimmun.ru/mimmun/article/downloadSuppFile/2988/14376; Государственная фармакопея Российской Федерации. XIV изд. М.: Министерство здравоохранения Российской Федерации, 2018. 7019 c.; A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath. ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/study/NCT04794218.; A Trial to Evaluate the Optimal Dose of MV-LASV (V182-001). ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/study/NCT04055454.; Abreu-Mota T., Hagen K.R., Cooper K., Jahrling P.B., Tan G., Wirblich C., Johnson R.F., Schnell M.J. Nonneutralizing antibodies elicited by recombinant Lassa-Rabies vaccine are critical for protection against Lassa fever. Nat. Commun., 2018, Vol. 9, no. 1, 4223. doi:10.1038/s41467-018-06741-w.; Ademusire B.I., Wieczorek K., Alonge A.T., Rajen A., Egbe J., Adebambo D., Offorbuike C.B., Trojan F., Przypaśniak Z., Oduguwa I.O., Omitoyin O., Balogun T.G. Prospects of Lassa Fever candidate vaccine. Afr. J. Infect. Dis., 2022, Vol. 16, no. 2, pp. 46-58.; Basinski A.J., Fichet-Calvet E., Sjodin A.R., Varrelman T.J., Remien C.H., Layman N.C., Bird B.H., Wolking D.J., Monagin C., Ghersi B.M., Barry P.A., Jarvis M.A., Gessler P.E., Nuismer S.L. Bridging the gap: Using reservoir ecology and human serosurveys to estimate Lassa virus spillover in West Africa. PLoS Comput. Biol., 2021, Vol. 17, no. 3, e1008811. doi:10.1371/journal.pcbi.1008811.; Cai Y., Ye C., Cheng B., Nogales A., Iwasaki M., Yu S., Cooper K., Liu D.X., Hart R., Adams R., Brady T., Postnikova E.N., Kurtz J., St. Claire M., Kuhn J.H., de la Torre J.C., Martínez-Sobrido L. A Lassa Fever live-attenuated vaccine based on codon deoptimization of the viral glycoprotein gene. mBio, 2020, Vol. 11, no. 1, e00039-20. doi:10.1128/mBio.00039-20.; Cross R.W., Fenton K.A., Woolsey C., Prasad A.N., Borisevich V., Agans K.N., Deer D.J., Dobias N.S., Fears A.C., Heinrich M.L., Geisbert J.B., Garry R.F., Branco L.M., Geisbert T.W. Monoclonal antibody therapy protects nonhuman primates against mucosal exposure to Lassa virus. Cell Rep. Med, 2024, Vol. 5, no. 2, 101392. doi:10.1016/j.xcrm.2024.101392.; Cross R.W., Mire C.E., Branco L.M., Geisbert J.B., Rowland M.M., Heinrich M.L., Goba A., Momoh M., Grant D.S., Fullah M., Khan S.H., Robinson J.E., Geisbert T.W., Garry R.F. Treatment of Lassa virus infection in outbred guinea pigs with first-in-class human monoclonal antibodies. Antivir. Res., 2016, Vol. 133, pp. 218-222.; Dan-Nwafor C.C., Furuse Y., Ilori E.A., Ipadeola O., Akabike K.O., Ahumibe A., Ukponu W., Bakare L., Okwor T.J., Joseph G., Mba N.G., Akano A., Olayinka A.T., Okoli I., Okea R.A., Makava F., Ugbogulu N., Oladele S., Namara G., Muwanguzi E.N., Naidoo D., Mutbam S.K., Okudo I., Woldetsadik S.F., Lasuba C.L., Ihekweazu C. Measures to control protracted large Lassa fever outbreak in Nigeria, 1 January to 28 April 2019. Euro Surveill., 2019, Vol. 24, no. 20. 1900272. doi:10.2807/1560-7917.ES.2019.24.20.1900272.; Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana. ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/study/NCT04093076.; Fichet-Calvet E. Lassa Fever: A rodent-human interaction. In: Johnson N. (ed.). The role of animals in emerging viral diseases. Academic Press, 2014, pp. 89-123.; Flórez-Álvarez L., de Souza E.E., Botosso V.F., de Oliveira D.B.L., Ho P.L., Taborda C.P., Palmisano G., Capurro M.L., Pinho J.R.R., Ferreira H.L., Minoprio P,. Arruda E., de Souza Ferreira L.C., Wrenger C., Durigon E.L. Hemorrhagic fever viruses: Pathogenesis, therapeutics, and emerging and re-emerging potential. Front. Microbiol., 2022, Vol. 13, 1040093. doi.org/10.3389/fmicb.2022.1040093.; Frame J.D., Verbrugge G.P., Gill R.G., Pinneo L. The use of Lassa fever convalescent plasma in Nigeria. Trans. R. Soc. Trop. Med. Hyg., 1984, Vol. 78, no. 3, pp. 319-324.; Godakova S.A., Noskov A.N., Vinogradova I.D., Ugriumova G.A., Solovyev A.I., Esmagambetov I.B., Tukhvatulin A.I., Logunov D.Y., Naroditsky B.S., Shcheblyakov D.V., Gintsburg A.L. Camelid VHHs Fused to Human Fc Fragments Provide Long Term Protection Against Botulinum Neurotoxin A in Mice. Toxins, 2019, Vol. 11, no. 8, 464. doi:10.3390/toxins11080464.; Hallam H.J., Hallam S., Rodriguez S.E., Barrett A.D.T., Beasley D.W.C., Chua A., Ksiazek T.G., Milligan G.N., Sathiyamoorthy V., Reece L.M. Baseline mapping of Lassa fever virology, epidemiology and vaccine research and development. NPJ Vaccines, 2018, Vol. 3, 11. doi:10.1038/s41541-018-0049-5.; Jahrling P.B., Frame J.D., Rhoderick J.B., Monson M.H. Endemic Lassa fever in Liberia. IV. Selection of optimally effective plasma for treatment by passive immunization. Trans. R. Soc. Trop. Med. Hyg., 1985, Vol. 79, no. 3, pp. 380-384.; Kanegae Y., Makimura M., Saito I. A simple and efficient method for purification of infectious recombinant adenovirus. Jpn. J Med. Sci. Biol., 1994, Vol. 47, no. 3, pp. 157-166.; Klitting R., Mehta S.B., Oguzie J.U., Oluniyi P.E., Pauthner M.G., Siddle K.J., Andersen K.G., Happi C.T., Sabeti P.C. Lassa Fever: epidemiology, immunology, diagnostics, and therapeutics. Curr. Top. Microbiol. Immunol., 2023, Vol. 440, pp. 23-65.; Logunov D.Y., Dolzhikova I.V., Shcheblyakov D.V., Tukhvatulin A.I., Zubkova O.V., Dzharullaeva A.S., Kovyrshina A.V., Lubenets N.L., Grousova D.M., Erokhova A.S., Botikov A.G., Izhaeva F.M., Popova O., Ozharovskaya T.A., Esmagambetov I.B., Favorskaya I.A., Zrelkin D.I., Voronina D.V., Shcherbinin D.N., Semikhin A.S., Simakova Y.V., Tokarskaya E.A., Egorova D.A., Shmarov M.M., Nikitenko N.A., Gushchin V.A., Smolyarchuk E.A., Zyryanov S.K., Borisevich S.V., Naroditsky B.S., Gintsburg A.L. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet, 2021, Vol. 397, no. 10275, pp. 671-681.; Logunov D.Y., Dolzhikova I.V., Zubkova O.V., Tukhvatullin A.I., Shcheblyakov D.V., Dzharullaeva A.S., Grousova D.M., Erokhova A.S., Kovyrshina A.V., Botikov A.G., Izhaeva F.M., Popova O., Ozharovskaya T.A., Esmagambetov I.B., Favorskaya I.A., Zrelkin D.I., Voronina D.V., Shcherbinin D.N., Semikhin A.S., Simakova Y.V., Tokarskaya E.A., Lubenets N.L., Egorova D.A., Shmarov M.M., Nikitenko N.A., Morozova L.F., Smolyarchuk E.A., Kryukov E.V., Babira V.F., Borisevich S.V., Naroditsky B.S., Gintsburg A.L. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, nonrandomised phase 1/2 studies from Russia. Lancet, 2020, Vol. 396, no. 10255, pp. 887-897.; Maruyama J., Mateer E.J., Manning J.T., Sattler R., Seregin A.V., Bukreyeva N., Jones F.R., Balint J.P., Gabitzsch E.S., Huang C., Paessler S. Adenoviral vector-based vaccine is fully protective against lethal Lassa fever challenge in Hartley guinea pigs. Vaccine, 2019, Vol. 37, no. 45, pp. 6824-6831.; Mehand M.S., Al-Shorbaji F., Millett P., Murgue B. The WHO R&D Blueprint: 2018 review of emerging infectious diseases requiring urgent research and development efforts. Antivir. Res., 2018, Vol. 159, pp. 63-67.; Mire C.E., Cross R.W., Geisbert J.B., Borisevich V., Agans K.N., Deer D.J., Heinrich M.L., Rowland M.M., Goba A., Momoh M., Boisen M.L., Grant D.S., Fullah M., Khan S.H., Fenton K.A., Robinson J.E., Branco L.M., Garry R.F., Geisbert T.W. Human-monoclonal-antibody therapy protects nonhuman primates against advanced Lassa fever. Nat. Med., 2017, Vol. 23, no. 10, pp. 1146-1149.; Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers. ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/study/NCT03805984.; Tschismarov R., Van Damme P,. Germain C., de Coster I., Mateo M., Reynard S., Journeaux A., Tomberger Y., Withanage K., Haslwanter D., Terler K., Schrauf S., Müllner M., Tauber E., Ramsauer K., Baize S. Immunogenicity, safety, and tolerability of a recombinant measles-vectored Lassa fever vaccine: a randomised, placebo-controlled, first-in-human trial. Lancet, 2023, Vol. 401, no. 10384, pp. 1267-1276.; Whitt M.A. Generation of VSV pseudotypes using recombinant ΔG-VSV for studies on virus entry, identification of entry inhibitors, and immune responses to vaccines. J. Virol. Met., 2010, Vol. 169, no. 2, pp. 365-374.; WHO Target Product Profile for Lassa virus Vaccine. World Health Organization. Available at: https://www.who.int/publications/m/item/who-target-product-profile-for-lassa-virus-vaccine.; https://www.mimmun.ru/mimmun/article/view/2988