biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Products10.30895/2221-996X-2026-26-3-311-323biopreparat-811Research ArticleТЕМА НОМЕРА: мРНК-ТЕХНОЛОГИИ В БИОМЕДИЦИНЕ: СОВРЕМЕННЫЕ ДОСТИЖЕНИЯ И РЕГУЛЯТОРНАЯ ПРАКТИКАISSUE TOPIC: mRNA TECHNOLOGIES IN BIOMEDICINE: CURRENT ADVANCES AND REGULATORY PRACTICEмРНК-вакцины для профилактики инфекционных заболеваний: обзор международного опыта оценки эффективности и безопасности по результатам клинических исследованийmRNA vaccines for the prevention of infectious diseases: A review of international experience in evaluating efficacy and safety based on clinical trial resultshttps://orcid.org/0000-0002-0352-522XБутырскийА. Ю.ButirskiyA. Yu.

Бутырский Алексей Юрьевич.

Петровский б-р, д. 8, стр. 2, Москва, 127051

Alexey Yu. Butirskiy.

8/2 Petrovsky Blvd., Moscow 127051

https://orcid.org/0000-0002-3241-1053КоровкинА. С.KorovkinA. S.

Коровкин Алексей Сергеевич - канд. мед. наук.

Петровский б-р, д. 8, стр. 2, Москва, 127051; Малый Казенный пер., д. 5А, Москва, 105064

Alexey S. Korovkin - Cand. Sci. (Med.).

8/2 Petrovsky Blvd., Moscow 127051; 5A Maly Kazenny Ln., Moscow 105064

a.s.korovkin@gmail.comhttps://orcid.org/0000-0003-0940-8080ГоренковД. В.GorenkovD. V.

Горенков Дмитрий Витальевич.

Петровский б-р, д. 8, стр. 2, Москва, 127051

Dmitry V. Gorenkov.

8/2 Petrovsky Blvd., Moscow 127051

https://orcid.org/0000-0003-4891-973XМеркуловВ. А.MerkulovV. A.

Меркулов Вадим Анатольевич - д-р мед. наук, проф.

Петровский б-р, д. 8, стр. 2, Москва, 127051; ул. Трубецкая, д. 8, стр. 2, Москва, 119991

Vadim A. Merkulov - Dr. Sci. (Med.), Prof.

8/2 Petrovsky Blvd., Moscow 127051; 8/2 Trubetskaya St., Moscow 119991

Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian FederationФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации; Федеральное государственное бюджетное научное учреждение «Научно-исследовательский институт вакцин и сывороток им. И.И. Мечникова»РоссияScientific Centre for Expert Evaluation of Medicinal Products; I. Mechnikov Research Institute of Vaccines and SeraRussian FederationФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации; Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет имени И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)РоссияScientific Centre for Expert Evaluation of Medicinal Products; I.M. Sechenov First Moscow State Medical University (Sechenov University)Russian Federation202605102026263311323Copyright © Бутырский А.Ю., Коровкин А.С., Горенков Д.В., Меркулов В.А., 20262026Бутырский А.Ю., Коровкин А.С., Горенков Д.В., Меркулов В.А.Butirskiy A.Y., Korovkin A.S., Gorenkov D.V., Merkulov V.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.biopreparations.ru/jour/article/view/811ВВЕДЕНИЕ

ВВЕДЕНИЕ. Платформенная мРНК-технология создания вакцин для профилактики инфекционных заболеваний была внедрена в медицинскую практику в период COVID-19, однако накопленный опыт клинического применения мРНК-вакцин требует систематизации применительно к другим инфекционным болезням. В связи с этим актуальным представляется обобщение данных об эффективности и безопасности таких мРНК-вакцин в условиях контролируемых клинических исследований для обоснования подходов к экспертизе иммунобиологических лекарственных препаратов подобного класса.

ЦЕЛЬ

ЦЕЛЬ. Обзор результатов клинических исследований мРНК-вакцин для профилактики респираторно-синцитиальной вирусной инфекции (РСВ-инфекции), цитомегаловирусной инфекции (ЦМВ-инфекции), сезонного гриппа, лихорадки Зика и бешенства для обобщения данных об их эффективности и безопасности с определением ограничений, связанных с применением суррогатных конечных точек и размером выборки.

ОБСУЖДЕНИЕ

ОБСУЖДЕНИЕ. Выполнен анализ публикаций в PubMed, eLIBRARY.RU и материалов в ClinicalTrials.gov, описывающих результаты контролируемых клинических исследований мРНК-вакцин для профилактики инфекционных болезней (за исключением COVID-19) за период 2016–2026 гг. Клиническая эффективность подтверждена только для вакцины mRNA-1345 против РСВ-инфекции: 83,7% (для эпизодов с 2 симптомами) и 82,4% (для эпизодов с 3 симптомами); профиль безопасности признан удовлетворительным. Для мРНК-вакцин против сезонного гриппа подтвержден благоприятный профиль безопасности и выраженная сероконверсия в реакции торможения гемагглютинации; показатели гуморального иммунитета были сопоставимы с зарегистрированными вакцинами. Вакцина mRNA-1647 против ЦМВ-инфекции после трехкратного введения стимулировала длительный иммунный ответ с индукцией Т-клеточного звена при благоприятном профиле безопасности. В исследовании вакцины для профилактики лихорадки Зика (mRNA-1325, mRNA-1893) показано наличие после вакцинации нейтрализующих антител (в реакции нейтрализации) у участников с различным исходным серологическим статусом по флавивирусам; профиль безопасности признан благоприятным. мРНК-вакцина CV7201 против бешенства индуцировала защитные титры вируснейтрализующих антител у 71% участников исследования при внутрикожном и у 46% — при внутримышечном введении; частота местных и системных нежелательных явлений (НЯ) была высокой (97 и 78% соответственно).

ЗАКЛЮЧЕНИЕ

ЗАКЛЮЧЕНИЕ. Результаты контролируемых клинических исследований мРНК-вакцин для профилактики РСВ-, ЦМВ-инфекций, сезонного гриппа, лихорадки Зика и бешенства продемонстрировали их потенциальную эффективность и приемлемый профиль безопасности, однако оценка большинства препаратов основана на суррогатных конечных точках и малых выборках, что является основными ограничениями проведенных исследований. Полученные результаты обосновывают необходимость дальнейших исследований с использованием конечных точек (клиническая эффективность, суррогатные маркеры) и пострегистрационного мониторинга безопасности (в первую очередь местные и системные НЯ).

INTRODUCTION

INTRODUCTION. The mRNA platform technology for creating vaccines against infectious diseases was introduced into clinical practice during the COVID-19 pandemic; however, the accumulated experience of clinical use of mRNA vaccines requires systematization in relation to other infectious diseases. Therefore, summarizing data on the efficacy and safety of such mRNA vaccines in controlled clinical trials is relevant for substantiating approaches to the regulatory evaluation of immunobiological medicinal products of this class.

AIM

AIM. To review the results of clinical trials of mRNA vaccines for the prevention of respiratory syncytial virus infection (RSV infection), cytomegalovirus infection (CMV infection), seasonal influenza, Zika fever, and rabies to summarize data on their efficacy and safety, identifying the limitations associated with the use of surrogate endpoints and sample size.

DISCUSSION

DISCUSSION. The authors analyzed publications in PubMed, eLIBRARY.RU and records in ClinicalTrials.gov describing the results of controlled clinical trials of mRNA vaccines for the prevention of infectious diseases (excluding COVID-19) from 2016 to 2026. Clinical efficacy was confirmed only for the mRNA-1345 vaccine against RSV infection: 83.7% (for episodes with 2 symptoms) and 82.4% (for episodes with 3 symptoms); the safety profile was considered satisfactory. For mRNA vaccines against seasonal influenza, a favorable safety profile and pronounced seroconversion in the hemagglutination inhibition assay were confirmed; the humoral immunity parameters were comparable to those of licensed vaccines. The mRNA-1647 vaccine against CMV infection, after a three-dose regimen, induced a durable immune response with the activation of T-cell immunity, along with a favorable safety profile. In a study of vaccines for the prevention of Zika fever (mRNA-1325, mRNA-1893), the presence of neutralizing antibodies (in a neutralization assay) after vaccination was demonstrated in participants with different baseline flavivirus serostatus; the safety profile was considered favorable. The mRNA vaccine CV7201 against rabies induced protective titers of virus-neutralizing antibodies in 71% of study participants after intradermal administration and in 46% after intramuscular administration; the incidence of local and systemic adverse events (AEs) was high (97% and 78%, respectively). Most studies were shown to have limitations associated with the assessment of efficacy using surrogate endpoints and an insufficient sample size to detect rare adverse events.

CONCLUSIONS

CONCLUSIONS. The results of controlled clinical trials of mRNA vaccines for the prevention of RSV and CMV infection, seasonal influenza, Zika fever, and rabies demonstrated their potential efficacy and acceptable safety profile; however, the evaluation of most products is based on surrogate endpoints and small sample sizes, which are the main limitations of the conducted studies. The findings substantiate the need for further research using endpoints (clinical efficacy, surrogate markers) and post-marketing safety monitoring (primarily for local and systemic AEs).

мРНК-вакциныклинические исследованияиммуногенность вакцинбезопасность вакцинкорреляты протекциисуррогатные конечные точкигриппреспираторно-синцитиальная вирусная инфекцияцитомегаловирусная инфекциялихорадка ЗикабешенствоmRNA vaccinesclinical trialsvaccine immunogenicityvaccine safetycorrelates of protectionsurrogate endpointsinfluenzarespiratory syncytial virus infectionscytomegalovirus infectionsZika virus infectionrabiesРабота выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00061-26-00 на проведение прикладных научных исследований (номер государственного учета НИР 124022200103-5).This study was conducted at the Scientific Centre for Expert Evaluation of Medicinal Products as part of State Assignment No. 056-00061-26-00 for applied scientific research (R&D state registration No. 124022200103-5).ReferencesZinatizadeh MR, Zarandi PK, Zinatizadeh M, et al. Efficacy of mRNA, adenoviral vector, and perfusion protein COVID-19 vaccines. Biomed Pharmacother. 2022;146:112527. https://doi.org/10.1016/j.biopha.2021.112527Zinatizadeh MR, Zarandi PK, Zinatizadeh M, et al. Efficacy of mRNA, adenoviral vector, and perfusion protein COVID-19 vaccines. Biomed Pharmacother. 2022;146:112527. https://doi.org/10.1016/j.biopha.2021.112527Hogan MJ, Pardi N. mRNA vaccines in the COVID-19 pandemic and beyond. Annu Rev Med. 2022;73:17–39. https://doi.org/10.1146/annurev-med-042420-112725Hogan MJ, Pardi N. mRNA vaccines in the COVID-19 pandemic and beyond. Annu Rev Med. 2022;73:17–39. https://doi.org/10.1146/annurev-med-042420-112725Hussain A, Yang H, Zhang M, et al. mRNA vaccines for COVID-19 and diverse diseases. J Control Release. 2022;345:314–33. https://doi.org/10.1016/j.jconrel.2022.03.032Hussain A, Yang H, Zhang M, et al. mRNA vaccines for COVID-19 and diverse diseases. J Control Release. 2022;345:314–33. https://doi.org/10.1016/j.jconrel.2022.03.032Liu MA, Zhou T, Sheets RL, et al. WHO informal consultation on regulatory considerations for evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases, 20-22 April 2021. Emerg Microbes Infect. 2022;11(1):384–91. https://doi.org/10.1080/22221751.2022.2026742Liu MA, Zhou T, Sheets RL, et al. WHO informal consultation on regulatory considerations for evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases, 20-22 April 2021. Emerg Microbes Infect. 2022;11(1):384–91. https://doi.org/10.1080/22221751.2022.2026742Bozkurt B, Kamat I, Hotez PJ. Myocarditis with COVID-19 mRNA vaccines. Circulation. 2021;144(6):471–84. https://doi.org/10.1161/circulationaha.121.056135Bozkurt B, Kamat I, Hotez PJ. Myocarditis with COVID-19 mRNA vaccines. Circulation. 2021;144(6):471–84. https://doi.org/10.1161/circulationaha.121.056135Patone M, Mei XW, Handunnetthi L, et al. Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. Nat Med. 2022;28(2):410–22. https://doi.org/10.1038/s41591-021-01630-0Patone M, Mei XW, Handunnetthi L, et al. Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. Nat Med. 2022;28(2):410–22. https://doi.org/10.1038/s41591-021-01630-0Melton DA, Krieg PA, Rebagliati MR, et al. Efficient in vitro synthesis of biologically active RNA and RNA hybridization probes from plasmids containing a bacteriophage SP6 promoter. Nucleic Acids Res. 1984;12(18):7035–56. https://doi.org/10.1093/nar/12.18.7035Melton DA, Krieg PA, Rebagliati MR, et al. Efficient in vitro synthesis of biologically active RNA and RNA hybridization probes from plasmids containing a bacteriophage SP6 promoter. Nucleic Acids Res. 1984;12(18):7035–56. https://doi.org/10.1093/nar/12.18.7035Tsui NB, Ng EK, Lo YM. Stability of endogenous and added RNA in blood specimens, serum, and plasma. Clin Chem. 2002;48(10):1647–53. https://doi.org/10.1093/clinchem/48.10.1647Tsui NB, Ng EK, Lo YM. Stability of endogenous and added RNA in blood specimens, serum, and plasma. Clin Chem. 2002;48(10):1647–53. https://doi.org/10.1093/clinchem/48.10.1647Kauffman KJ, Webber MJ, Anderson DG. Materials for non-viral intracellular delivery of messenger RNA therapeutics. J Control Release. 2016;240:227–34. https://doi.org/10.1016/j.jconrel.2015.12.032Kauffman KJ, Webber MJ, Anderson DG. Materials for non-viral intracellular delivery of messenger RNA therapeutics. J Control Release. 2016;240:227–34. https://doi.org/10.1016/j.jconrel.2015.12.032Young AP, Kanneganti TD. For “U” the bell tolls: Pseudouridine evades TLR detection. Mol Cell. 2025;85(17):3206–8. https://doi.org/10.1016/j.molcel.2025.08.008Young AP, Kanneganti TD. For “U” the bell tolls: Pseudouridine evades TLR detection. Mol Cell. 2025;85(17):3206–8. https://doi.org/10.1016/j.molcel.2025.08.008Karikó K, Buckstein M, Ni H, Weissman D. Suppression of RNA recognition by Toll-like receptors: the impact of nucleoside modification and the evolutionary origin of RNA. Immunity. 2005;23(2):165–75. https://doi.org/10.1016/j.immuni.2005.06.008Karikó K, Buckstein M, Ni H, Weissman D. Suppression of RNA recognition by Toll-like receptors: the impact of nucleoside modification and the evolutionary origin of RNA. Immunity. 2005;23(2):165–75. https://doi.org/10.1016/j.immuni.2005.06.008Guan S, Rosenecker J. Nanotechnologies in delivery of mRNA therapeutics using nonviral vector-based delivery systems. Gene Ther. 2017;24(3):133–43. https://doi.org/10.1038/gt.2017.5Guan S, Rosenecker J. Nanotechnologies in delivery of mRNA therapeutics using nonviral vector-based delivery systems. Gene Ther. 2017;24(3):133–43. https://doi.org/10.1038/gt.2017.5Pardi N, Tuyishime S, Muramatsu H, et al. Expression kinetics of nucleoside-modified mRNA delivered in lipid nanoparticles to mice by various routes. J Control Release. 2015;217:345–51. https://doi.org/10.1016/j.jconrel.2015.08.007Pardi N, Tuyishime S, Muramatsu H, et al. Expression kinetics of nucleoside-modified mRNA delivered in lipid nanoparticles to mice by various routes. J Control Release. 2015;217:345–51. https://doi.org/10.1016/j.jconrel.2015.08.007Patel S, Ashwanikumar N, Robinson E, et al. Naturally-occurring cholesterol analogues in lipid nanoparticles induce polymorphic shape and enhance intracellular delivery of mRNA. Nat Commun. 2020;11(1):983. https://doi.org/10.1038/s41467-020-14527-2Patel S, Ashwanikumar N, Robinson E, et al. Naturally-occurring cholesterol analogues in lipid nanoparticles induce polymorphic shape and enhance intracellular delivery of mRNA. Nat Commun. 2020;11(1):983. https://doi.org/10.1038/s41467-020-14527-2Голяк НС, Царенков ВМ, Сушинская ОА и др. Достижения в области разработки вакцин на основе мРНК. Вестник фармации. 2025;(2):77–97. https://doi.org/10.52540/2074-9457.2025.2.77Golyak NS, Tsarenkov VM, Sushinskaya OA, et al. Advances in the development of mRNA-vaccines. Vestnik Farmatsii. 2025;(2):77–97 (In Russ.). https://doi.org/10.52540/2074-9457.2025.2.77Литвинова ВР, Рудометов АП, Карпенко ЛИ, Ильичев АА. Платформа мРНК-вакцин: особенности получения и доставки мРНК. Биоорганическая химия. 2023;49(2):134–52. https://doi.org/10.31857/S013234232302015XLitvinova VR, Rudometov AP, Karpenko LI, Ilyichev AA. mRNA-vaccine platform: Features of obtaining and delivery of mRNA. Russian Journal of Bioorganic Chemistry. 2023;49(2):134–52 (In Russ.). https://doi.org/10.31857/S013234232302015XWilson E, Goswami J, Baqui AH, et. al. Efficacy and safety of an mRNA-based RSV PreF vaccine in older adults. N Engl J Med. 2023;389(24):2233–44. https://doi.org/10.1056/NEJMoa2307079Wilson E, Goswami J, Baqui AH, et. al. Efficacy and safety of an mRNA-based RSV PreF vaccine in older adults. N Engl J Med. 2023;389(24):2233–44. https://doi.org/10.1056/NEJMoa2307079Goswami J, Cardona JF, Hsu DC, et al. Safety and immunogenicity of mRNA-1345 RSV vaccine coadministered with an influenza or COVID-19 vaccine in adults aged 50 years or older: An observer-blinded, placebo-controlled, randomised, phase 3 trial. Lancet Infect Dis. 2025;25(4):411–23. https://doi.org/10.1016/S1473-3099(24)00589-9Goswami J, Cardona JF, Hsu DC, et al. Safety and immunogenicity of mRNA-1345 RSV vaccine coadministered with an influenza or COVID-19 vaccine in adults aged 50 years or older: An observer-blinded, placebo-controlled, randomised, phase 3 trial. Lancet Infect Dis. 2025;25(4):411–23. https://doi.org/10.1016/S1473-3099(24)00589-9Bajema KL, Bui DP, Yan L, et al. Severity and long-term mortality of COVID-19, influenza, and respiratory syncytial virus. JAMA Intern Med. 2025;185(3):324–34. https://doi.org/10.1001/jamainternmed.2024.7452Bajema KL, Bui DP, Yan L, et al. Severity and long-term mortality of COVID-19, influenza, and respiratory syncytial virus. JAMA Intern Med. 2025;185(3):324–34. https://doi.org/10.1001/jamainternmed.2024.7452Hitchens A, Candrilli SD, Carrico J, et al. Prevalence of health conditions associated with higher risk for severe respiratory syncytial virus, influenza, or COVID-19. Curr Med Res Opin. 2025;41(7):1353–61. https://doi.org/10.1080/03007995.2025.2535456Hitchens A, Candrilli SD, Carrico J, et al. Prevalence of health conditions associated with higher risk for severe respiratory syncytial virus, influenza, or COVID-19. Curr Med Res Opin. 2025;41(7):1353–61. https://doi.org/10.1080/03007995.2025.2535456Ma C, Du J, Lan L, et al. Immune correlates analysis of mRNA-1345 RSV vaccine efficacy clinical trial. Nat Commun. 2025;16(1):6118. https://doi.org/10.1038/s41467-025-61153-xMa C, Du J, Lan L, et al. Immune correlates analysis of mRNA-1345 RSV vaccine efficacy clinical trial. Nat Commun. 2025;16(1):6118. https://doi.org/10.1038/s41467-025-61153-xAnanworanich J, Lee IT, Ensz D, et al. Safety and Immunogenicity of mRNA-1010, an Investigational Seasonal Influenza Vaccine, in Healthy Adults: Final Results From a Phase 1/2 Randomized Trial. J Infect Dis. 2025 Feb 4;231(1):e113-e122. https://doi.org/10.1093/infdis/jiae329Ananworanich J, Lee IT, Ensz D, et al. Safety and Immunogenicity of mRNA-1010, an Investigational Seasonal Influenza Vaccine, in Healthy Adults: Final Results From a Phase 1/2 Randomized Trial. J Infect Dis. 2025 Feb 4;231(1):e113-e122. https://doi.org/10.1093/infdis/jiae329Hsu D, Jayaraman A, Pucci A, et al. Safety and immunogenicity of mRNA-based seasonal influenza vaccines formulated to include multiple A/H3N2 strains with or without the B/ Yamagata strain in US adults aged 50–75 years: A phase 1/2, open-label, randomised trial. Lancet Infect Dis. 2025;25(1):25–35. https://doi.org/10.1016/s1473-3099(24)00493-6Hsu D, Jayaraman A, Pucci A, et al. Safety and immunogenicity of mRNA-based seasonal influenza vaccines formulated to include multiple A/H3N2 strains with or without the B/ Yamagata strain in US adults aged 50–75 years: A phase 1/2, open-label, randomised trial. Lancet Infect Dis. 2025;25(1):25–35. https://doi.org/10.1016/s1473-3099(24)00493-6Fierro C, Brune D, Shaw M, et al. Safety and immunogenicity of a messenger RNA-based cytomegalovirus vaccine in healthy adults: results from a phase 1 randomized clinical trial. J Infect Dis. 2024;230(3):e668–78. https://doi.org/10.1093/infdis/jiae114Fierro C, Brune D, Shaw M, et al. Safety and immunogenicity of a messenger RNA-based cytomegalovirus vaccine in healthy adults: results from a phase 1 randomized clinical trial. J Infect Dis. 2024;230(3):e668–78. https://doi.org/10.1093/infdis/jiae114Wu K, Hou YJ, Makrinos D, et al. Characterization of humoral and cellular immunologic responses to an mRNA-based human cytomegalovirus vaccine from a phase 1 trial of healthy adults. J Virol. 2024;98(4):e0160323. https://doi.org/10.1128/jvi.01603-23Wu K, Hou YJ, Makrinos D, et al. Characterization of humoral and cellular immunologic responses to an mRNA-based human cytomegalovirus vaccine from a phase 1 trial of healthy adults. J Virol. 2024;98(4):e0160323. https://doi.org/10.1128/jvi.01603-23Hu X, Karthigeyan KP, Herbek S, et al. Human cytomegalovirus mRNA-1647 vaccine candidate elicits potent and broad neutralization and higher antibody-dependent cellular cytotoxicity responses than the gB/MF59 vaccine. J Infect Dis. 2024;230(2):455–66. https://doi.org/10.1093/infdis/jiad593Hu X, Karthigeyan KP, Herbek S, et al. Human cytomegalovirus mRNA-1647 vaccine candidate elicits potent and broad neutralization and higher antibody-dependent cellular cytotoxicity responses than the gB/MF59 vaccine. J Infect Dis. 2024;230(2):455–66. https://doi.org/10.1093/infdis/jiad593Das R, Blázquez-Gamero D, Bernstein DI, et al. Safety, efficacy, and immunogenicity of a replication-defective human cytomegalovirus vaccine, V160, in cytomegalovirus-seronegative women: A double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Infect Dis. 2023;23(12):1383–94. https://doi.org/10.1016/s1473-3099(23)00343-2Das R, Blázquez-Gamero D, Bernstein DI, et al. Safety, efficacy, and immunogenicity of a replication-defective human cytomegalovirus vaccine, V160, in cytomegalovirus-seronegative women: A double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Infect Dis. 2023;23(12):1383–94. https://doi.org/10.1016/s1473-3099(23)00343-2Essink B, Chu L, Seger W, et al. The safety and immunogenicity of two Zika virus mRNA vaccine candidates in healthy flavivirus baseline seropositive and seronegative adults: the results of two randomised, placebo-controlled, dose-ranging, phase 1 clinical trials. Lancet Infect Dis. 2023;23(5):621–33. https://doi.org/10.1016/s1473-3099(22)00764-2Essink B, Chu L, Seger W, et al. The safety and immunogenicity of two Zika virus mRNA vaccine candidates in healthy flavivirus baseline seropositive and seronegative adults: the results of two randomised, placebo-controlled, dose-ranging, phase 1 clinical trials. Lancet Infect Dis. 2023;23(5):621–33. https://doi.org/10.1016/s1473-3099(22)00764-2Alberer M, Gnad-Vogt U, Hong HS, et al. Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: An open-label, non-randomised, prospective, first-in-human phase 1 clinical trial. Lancet. 2017;390(10101):1511–20. https://doi.org/10.1016/s0140-6736(17)31665-3Alberer M, Gnad-Vogt U, Hong HS, et al. Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: An open-label, non-randomised, prospective, first-in-human phase 1 clinical trial. Lancet. 2017;390(10101):1511–20. https://doi.org/10.1016/s0140-6736(17)31665-3

The authors declare that there are no conflicts of interest present.