biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Products10.30895/2221-996X-2019-19-4-215-224biopreparat-227Research ArticleОБЗОРЫREVIEWSЭффективность и безопасность вакцин для профилактики ротавирусной инфекцииVaccine Safety and Efficacy in Preventing Rotavirus Infectionhttps://orcid.org/0000-0002-7164-2890ШевцовВ. А.ShevtsovV. A.

Шевцов Владимир Александрович, канд. мед. наук

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

Vladimir A. Shevtsov, Cand. Sci. (Med.)

8/2 Petrovsky Blvd, Moscow 127051

Shevtsov@expmed.ruhttps://orcid.org/0000-0002-3250-0937ЕвреиноваЕ. Э.EvreinovaE. E.

Евреинова Елена Эдуардовна, канд. биол. наук

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

Elena E. Evreinova, Cand. Sci. (Biol.)

8/2 Petrovsky Blvd, Moscow 127051

Evreinova@expmed.ruhttps://orcid.org/0000-0003-0695-3446ИндиковаИ. Н.IndikovaI. N.

Индикова Ирина Николаевна, канд. биол. наук

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

Irina N. Indikova, Cand. Sci. (Biol.)

8/2 Petrovsky Blvd, Moscow 127051

Indikova@expmed.ruhttps://orcid.org/0000-0001-6269-0201ХантимироваЛ. М.KhantimirovaL. M.

Хантимирова Лейсан Маратовна

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

Leysan M. Khantimirova

8/2 Petrovsky Blvd, Moscow 127051

Khantimirova@expmed.ruhttps://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

diyarl@ya.ruhttps://orcid.org/0000-0003-4536-2040РукавишниковА. В.RukavishnikovA. V.

Рукавишников Андрей Владимирович, канд. биол. наук

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

Andrey V. Rukavishnikov, Cand. Sci. (Biol.)

8/2 Petrovsky Blvd, Moscow 127051

Rukavishnikov@expmed.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation201928102019194215224Copyright © Шевцов В.А., Евреинова Е.Э., Индикова И.Н., Хантимирова Л.М., Горенков Д.В., Рукавишников А.В., 20192019Шевцов В.А., Евреинова Е.Э., Индикова И.Н., Хантимирова Л.М., Горенков Д.В., Рукавишников А.В.Shevtsov V.A., Evreinova E.E., Indikova I.N., Khantimirova L.M., Gorenkov D.V., Rukavishnikov A.V.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/227

Ротавирусная инфекция вызывает острый гастроэнтерит и является одной из основных причин приводящей к смерти от тяжелой дегидратирующей диареи у детей младше 5 лет во всем мире. Живые аттенуированные ротавирусные вакцины являются единственным средством профилактики тяжелых форм заболевания. Цель работы — анализ двадцатилетнего опыта иммунопрофилактики ротавирусной инфекции в мире. Представлены результаты анализа эффективности и безопасности при долговременном применении вакцин Rotarix® (Бельгия) и RotaTeq® (США) против ротавирусной инфекции в государствах Европейского региона ВОЗ, Европейского Союза (ЕС) и других стран. Рассмотрены вопросы разработки корреляционных показателей иммунной защиты вакцин, а также экспертная оценка эффективности и безопасности новых вакцин Rotavac® и Rotasiil® (Индия) в клинических исследованиях. Проведен анализ мирового опыта их применения в странах, в которых детская смертность от диареи не регистрируется. Обобщены результаты клинических исследований по применению новых вакцин, преквалифицированных ВОЗ в 2018 г., в регионах, в которых регистрируется высокая детская смертность от диареи. Обоснована целесообразность массовой вакцинации. Установлено, что вакцинация не только уменьшает количество случаев госпитализаций иммунизированных детей, но и обеспечивает формирование популяционного иммунитета. Вакцины Rotarix® и RotaTeq® разрешены к применению или включены в национальные календари профилактических прививок многих стран, но вакцинация в большинстве государств не является обязательной. Охват вакцинацией в странах ЕС — 24 %. Для снижения имеющегося риска предназначены альтернативные схемы вакцинации живыми аттенуированными вакцинами на основе штаммов, выделенных от новорожденных детей, а также парентеральными ротавирусными вакцинами, которые не способны к размножению в кишечнике. Сделан вывод о том, что внедрение живых ротавирусных вакцин в календарь профилактических прививок должно сопровождаться изучением частоты возникновения инвагинации тонкого кишечника до и после введения массовой иммунизации и проведением мероприятий по активному фармаконадзору.

The rotavirus infection causes acute gastroenteritis and is a major cause of lethal severe dehydrating diarrhoea in children under 5 years of age worldwide. Live attenuated rotavirus vaccines are the only means of preventing severe forms of the disease. The aim of the study was to analyse the twenty-year international experience of prophylactic immunisation against rotavirus infection. The paper summarises safety and efficacy data on the long-term use of Rotarix® (Belgium) and RotaTeq® (USA) for the prevention of rotavirus infection in the WHO European Region, the European Union and other countries. It addresses the development of correlates of immune protection for vaccines as well as evaluation of efficacy and safety of the new vaccines Rotavac® and Rotasiil® (India) in clinical trials. The authors analysed international experience of using the vaccines in countries that do not keep records of infant mortality from diarrhoea. The study summarises the results of clinical studies on the use of new vaccines prequalified by WHO in 2018 in regions with high rates of infant mortality from diarrhoea. It was demonstrated that vaccination not only reduces the rates of hospital admission of immunised children, but also contributes to the development of herd immunity. Rotarix® and RotaTeq® vaccines are authorised or included in the national immunisation schedules of many countries, but this type of vaccination is not mandatory in most of these countries. Vaccination coverage in the EU countries is about 24 %. Alternative vaccination schemes using live attenuated vaccines based on strains derived from newborn children, and parenteral rotavirus vaccines which do not replicate in the intestine may help reduce existing risks. It was concluded that the introduction of live rotavirus vaccines in immunisation schedules should be accompanied by the analysis of incidence of intussusception of the small intestine before and after the introduction of mass immunisation, and by active pharmacovigilance.

ротавирусная инфекцияживые аттенуированные вакцинынереплицирующиеся вакциныэффективность и безопасность вакцининвагинацияпопуляционный иммунитетrotavirus infectionlive attenuated vaccinenon-replicating vaccinesefficacy and safety of vaccinesintussusceptionherd immunityРабота выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00154-19-00 на проведение прикладных научных исследований (номер государственного учета НИР AAAA-A18-118021590046-9).ReferencesBruijning-Verhagen P, Mangen MJ, Felderhof M, Hartwig NG, van Houten M, Winkel L, et al. Targeted rotavirus vaccination of high-risk infants; a low cost and highly cost-effective alternative to universal vaccination. BMC Med. 2013;11:112. https://doi.org/10.1186/1741-7015-11-112Bruijning-Verhagen P, Mangen MJ, Felderhof M, Hartwig NG, van Houten M, Winkel L, et al. Targeted rotavirus vaccination of high-risk infants; a low cost and highly cost-effective alternative to universal vaccination. BMC Med. 2013;11:112. https://doi.org/10.1186/1741-7015-11-112Rheingans RD, Antil L, Dreibelbis R, Podewils LJ, Bresee JS, Parashar UD. Economic costs of rotavirus gastroenteritis and cost-effectiveness of vaccination in developing countries. J Infect Dis. 2009;200(Suppl. 1):S16–27. https://doi.org/10.1086/605026Rheingans RD, Antil L, Dreibelbis R, Podewils LJ, Bresee JS, Parashar UD. Economic costs of rotavirus gastroenteritis and cost-effectiveness of vaccination in developing countries. J Infect Dis. 2009;200(Suppl. 1):S16–27. https://doi.org/10.1086/605026Haider S, Chaikledkaew U, Thavorncharoensap M, Youngkong S, Islam MA, Thakkinstian A. Systematic Review and Meta-Analysis of Cost-effectiveness of Rotavirus Vaccine in Low-Income and Lower-Middle-Income Countries. Open Forum Infect Dis. 2019;6(4):ofz117. Published 2019 Mar 8. doi:10.1093/ofid/ofz117Haider S, Chaikledkaew U, Thavorncharoensap M, Youngkong S, Islam MA, Thakkinstian A. Systematic Review and Meta-Analysis of Cost-effectiveness of Rotavirus Vaccine in Low-Income and Lower-Middle-Income Countries. Open Forum Infect Dis. 2019;6(4):ofz117. Published 2019 Mar 8. doi:10.1093/ofid/ofz117Parez N, Giaquinto C, Du Roure C, Martinon-Torres F, Spoulou V, Van Damme P, Vesikari T. Rotavirus vaccination in Europe: drivers and barriers. Lancet Infect Dis. 2014;14(5):416–25. https://doi.org/10.1016/S1473-3099(14)70035-0Parez N, Giaquinto C, Du Roure C, Martinon-Torres F, Spoulou V, Van Damme P, Vesikari T. Rotavirus vaccination in Europe: drivers and barriers. Lancet Infect Dis. 2014;14(5):416–25. https://doi.org/10.1016/S1473-3099(14)70035-0Ricciardi GW, Toumi M, Weil-Olivier C, Ruitenberg EJ, Dankó D, Duru G, et al. Comparison of NITAG policies and working processes in selected developed countries. Vaccine. 2015;33(1):3–11. https://doi.org/10.1016/j.vaccine.2014.09.023Ricciardi GW, Toumi M, Weil-Olivier C, Ruitenberg EJ, Dankó D, Duru G, et al. Comparison of NITAG policies and working processes in selected developed countries. Vaccine. 2015;33(1):3–11. https://doi.org/10.1016/j.vaccine.2014.09.023St-Martin G, Lindstrand A, Sandbu S, Fischer TK. Selection and interpretation of scientific evidence in preparation for policy decisions: a case study regarding introduction of rotavirus vaccine into National Immunization Programs in Sweden, Norway, Finland, and Denmark. Front Public Health. 2018;6:131. https://doi.org/10.3389/fpubh.2018.00131St-Martin G, Lindstrand A, Sandbu S, Fischer TK. Selection and interpretation of scientific evidence in preparation for policy decisions: a case study regarding introduction of rotavirus vaccine into National Immunization Programs in Sweden, Norway, Finland, and Denmark. Front Public Health. 2018;6:131. https://doi.org/10.3389/fpubh.2018.00131Bernstein DI. Rotavirus vaccines: mind your Ps and Gs. J Infect Dis. 2018;218(4):519–21. https://doi.org/10.1093/infdis/jiy203Bernstein DI. Rotavirus vaccines: mind your Ps and Gs. J Infect Dis. 2018;218(4):519–21. https://doi.org/10.1093/infdis/jiy203Tate JE, Parashar UD. Approaches to monitoring intussusception following rotavirus vaccination. Expert Opin Drug Saf. 2019;18(1):21–7. https://doi.org/10.1080/14740338.2019.1561857Tate JE, Parashar UD. Approaches to monitoring intussusception following rotavirus vaccination. Expert Opin Drug Saf. 2019;18(1):21–7. https://doi.org/10.1080/14740338.2019.1561857Pollard SL, Malpica-Llanos T, Friberg IK, Fischer-Walker C, Ashraf S, Walker N. Estimating the herd immunity effect of rotavirus vaccine. Vaccine. 2015;33(32):3795–800. https://doi.org/10.1016/j.vaccine.2015.06.064Pollard SL, Malpica-Llanos T, Friberg IK, Fischer-Walker C, Ashraf S, Walker N. Estimating the herd immunity effect of rotavirus vaccine. Vaccine. 2015;33(32):3795–800. https://doi.org/10.1016/j.vaccine.2015.06.064Burke RM, Tate JE, Dahl RM, Aliabadi N, Parashar UD. Rotavirus vaccination is associated with reduced seizure hospitalization risk among commercially insured US children. Clin Infect Dis. 2018;67(10):1614–6. https://doi.org/10.1093/cid/ciy424Burke RM, Tate JE, Dahl RM, Aliabadi N, Parashar UD. Rotavirus vaccination is associated with reduced seizure hospitalization risk among commercially insured US children. Clin Infect Dis. 2018;67(10):1614–6. https://doi.org/10.1093/cid/ciy424Payne DC, Baggs J, Zerr DM, Klein NP, Yih K, Glanz J, et al. Protective association between rotavirus vaccination and childhood seizures in the year following vaccination in US children. Clin Infect Dis. 2014;58(2):173–7. https://doi.org/10.1093/cid/cit671Payne DC, Baggs J, Zerr DM, Klein NP, Yih K, Glanz J, et al. Protective association between rotavirus vaccination and childhood seizures in the year following vaccination in US children. Clin Infect Dis. 2014;58(2):173–7. https://doi.org/10.1093/cid/cit671Standaert B, Strens D, Li X, Schecroun N, Raes M. The sustained rotavirus vaccination impact on nosocomial infection, duration of hospital stay, and age: the RotaBIS study (2005–2012). Infect Dis Ther. 2016;5(4):509–24. https://doi.org/10.1007/s40121-016-0131-0Standaert B, Strens D, Li X, Schecroun N, Raes M. The sustained rotavirus vaccination impact on nosocomial infection, duration of hospital stay, and age: the RotaBIS study (2005–2012). Infect Dis Ther. 2016;5(4):509–24. https://doi.org/10.1007/s40121-016-0131-0Hutubessy RC, Baltussen RM, Torres-Edejer TT, Evans DB. Generalised cost-effectiveness analysis: an aid to decision making in health. Appl Health Econ Health Policy. 2002;1(2):89–95.Hutubessy RC, Baltussen RM, Torres-Edejer TT, Evans DB. Generalised cost-effectiveness analysis: an aid to decision making in health. Appl Health Econ Health Policy. 2002;1(2):89–95.Glass RI. Priority setting for the introduction of rotavirus vaccine: what evidence was essential? Cost Eff Resour Alloc. 2018;16(Suppl. 1):42. https://doi.org/10.1186/s12962-018-0126-7Glass RI. Priority setting for the introduction of rotavirus vaccine: what evidence was essential? Cost Eff Resour Alloc. 2018;16(Suppl. 1):42. https://doi.org/10.1186/s12962-018-0126-7Oldin C, Golsäter M, Schollin Ask L, Fredriksson S, Stenmarker M. Introduction of rotavirus vaccination in a Swedish region: assessing parental decision-making, obtained vaccination coverage and resulting hospital admissions. Acta Paediatr. 2019;108(7):1329–37. https://doi.org/10.1111/apa.14674Oldin C, Golsäter M, Schollin Ask L, Fredriksson S, Stenmarker M. Introduction of rotavirus vaccination in a Swedish region: assessing parental decision-making, obtained vaccination coverage and resulting hospital admissions. Acta Paediatr. 2019;108(7):1329–37. https://doi.org/10.1111/apa.14674Баранов АА, Намазова-Баранова ЛС, Таточенко ВК, Вишнева ЕА, Федосеенко МВ, Селимзянова ЛР и др. Ротавирусная инфекция у детей – нерешенная проблема. Обзор рекомендаций по вакцинопрофилактике. Педиатрическая фармакология. 2017;14(4):248–57. https://doi.org/10.15690/pf.v14i4.1756Baranov AА, Namazova-Baranova LS, Tatochenko VK, Vishneva EА, Fedoseenko MV, Selimzianova LR, et al. Rotavirus infection in children is an unsolved problem. Review of guidelines for vaccinal prevention. Pediatricheskaya farmakologiya = Pediatric pharmacology. 2017;14(4):248–57 (In Russ.) https://doi.org/10.15690/pf.v14i4.1756Рудакова АВ, Харит СМ, Усков АН, Лобзин ЮВ. Оценка предотвращенных затрат на терапию ротавирусной инфекции при вакцинации 5-валентной вакциной в Российской Федерации. Журнал инфектологии. 2014;6(2):71–5.Rudakova AV, Kharit SM, Uskov AN, Lobzin YV. Assessment of reduction of rotavirus infection burden in case of vaccination with a pentavalent vaccine in Russian Federation. Zhurnal infektologii = Journal Infectology. 2014;6(2):71–5 (In Russ.)Костинов МП, Зверев ВВ. Экономическая эффективность вакцинации против ротавирусной инфекции в Российской Федерации. Журнал микробиологии, эпидемиологии и иммунобиологии. 2012;(3):50–5.Kostinov MP, Zverev VV. Economic efficiency of vaccination against rotavirus infection in the Russian Federation. Zhurnal mikrobiologii, epidemiologii i immunobiologii = Journal of Microbiology, Epidemiology and Immunobiology. 2012;(3):50–5 (In Russ.).Midthun K, Kapikian AZ. Rotavirus vaccines: an overview. Clin Microbiol Rev. 1996;9(3):423–34. https://doi.org/10.1128/CMR.9.3.423Midthun K, Kapikian AZ. Rotavirus vaccines: an overview. Clin Microbiol Rev. 1996;9(3):423–34. https://doi.org/10.1128/CMR.9.3.423Ward RL, McNeal MM, Steele AD. Why does the world need another rotavirus vaccine? Ther Clin Risk Manag. 2008;4(1):49–63. https://doi.org/10.2147/tcrm.s821Ward RL, McNeal MM, Steele AD. Why does the world need another rotavirus vaccine? Ther Clin Risk Manag. 2008;4(1):49–63. https://doi.org/10.2147/tcrm.s821Kapikian AZ, Simonsen L, Vesikari T, Hoshino Y, Morens DM, Chanock RM, et al. A hexavalent human rotavirus-bovine rotavirus (UK) reassortant vaccine designed for use in developing countries and delivered in a schedule with the potential to eliminate the risk of intussusception. J Infect Dis. 2005;192(Suppl. 1):S22–9. https://doi.org/10.1086/431510Kapikian AZ, Simonsen L, Vesikari T, Hoshino Y, Morens DM, Chanock RM, et al. A hexavalent human rotavirus-bovine rotavirus (UK) reassortant vaccine designed for use in developing countries and delivered in a schedule with the potential to eliminate the risk of intussusception. J Infect Dis. 2005;192(Suppl. 1):S22–9. https://doi.org/10.1086/431510Vesikari T, Karvonen AV, Majuri J, Zeng SQ, Pang XL, Kohberger R, et al. Safety, efficacy, and immunogenicity of 2 doses of bovine-human (UK) and rhesus–rhesus-human rotavirus reassortant tetravalent vaccines in Finnish children. J Infect Dis. 2006;194(3):370–6. https://doi.org/10.1086/505151Vesikari T, Karvonen AV, Majuri J, Zeng SQ, Pang XL, Kohberger R, et al. Safety, efficacy, and immunogenicity of 2 doses of bovine-human (UK) and rhesus–rhesus-human rotavirus reassortant tetravalent vaccines in Finnish children. J Infect Dis. 2006;194(3):370–6. https://doi.org/10.1086/505151Zade JK, Kulkarni PS, Desai SA, Sabale RN, Naik SP, Dhere RM. Bovine rotavirus pentavalent vaccine development in India. Vaccine. 2014;32(Suppl. 1):A124–8. https://doi.org/10.1016/j.vaccine.2014.03.003Zade JK, Kulkarni PS, Desai SA, Sabale RN, Naik SP, Dhere RM. Bovine rotavirus pentavalent vaccine development in India. Vaccine. 2014;32(Suppl. 1):A124–8. https://doi.org/10.1016/j.vaccine.2014.03.003Desai S, Rathi N, Kawade A, Venkatramanan P, Kundu R, Lalwani SK, et al. Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine. Vaccine. 2018;36(37):5519–23. https://doi.org/10.1016/j.vaccine.2018.07.064Desai S, Rathi N, Kawade A, Venkatramanan P, Kundu R, Lalwani SK, et al. Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine. Vaccine. 2018;36(37):5519–23. https://doi.org/10.1016/j.vaccine.2018.07.064Dang DA, Nguyen VT, Vu DT, Nguyen TH, Nguyen DM, Yuhuan W, et al. A dose-escalation safety and immunogenicity study of a new live attenuated human rotavirus vaccine (Rotavin-M1) in Vietnamese children. Vaccine. 2012;30(Suppl. 1):A114–21. https://doi.org/10.1016/j.vaccine.2011.07.118Dang DA, Nguyen VT, Vu DT, Nguyen TH, Nguyen DM, Yuhuan W, et al. A dose-escalation safety and immunogenicity study of a new live attenuated human rotavirus vaccine (Rotavin-M1) in Vietnamese children. Vaccine. 2012;30(Suppl. 1):A114–21. https://doi.org/10.1016/j.vaccine.2011.07.118Madhi SA, Parashar UD. 116E rotavirus vaccine development: a successful alliance. Lancet. 2014;383(9935):2106–7. https://doi.org/10.1016/S0140-6736(13)62701-4Madhi SA, Parashar UD. 116E rotavirus vaccine development: a successful alliance. Lancet. 2014;383(9935):2106–7. https://doi.org/10.1016/S0140-6736(13)62701-4Bines JE, At Thobari J, Satria CD, Handley A, Watts E, Cowley D, et al. Human neonatal rotavirus vaccine (RV3-BB) to target rotavirus from birth. N Engl J Med. 2018;378(8):719–30. https://doi.org/10.1056/NEJMoa1706804Bines JE, At Thobari J, Satria CD, Handley A, Watts E, Cowley D, et al. Human neonatal rotavirus vaccine (RV3-BB) to target rotavirus from birth. N Engl J Med. 2018;378(8):719–30. https://doi.org/10.1056/NEJMoa1706804Arnold MM. Rotavirus vaccines: why continued investment in research is necessary. Curr Clin Microbiol Rep. 2018;5(1):73–81.Arnold MM. Rotavirus vaccines: why continued investment in research is necessary. Curr Clin Microbiol Rep. 2018;5(1):73–81.Groome MJ, Koen A, Fix A, Page N, Jose L, Madhi SA, et al. Safety and immunogenicity of a parenteral P2-VP8-P[8] subunit rotavirus vaccine in toddlers and infants in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2017;17(8):843–53. https://doi.org/10.1016/S1473-3099(17)30242-6Groome MJ, Koen A, Fix A, Page N, Jose L, Madhi SA, et al. Safety and immunogenicity of a parenteral P2-VP8-P[8] subunit rotavirus vaccine in toddlers and infants in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2017;17(8):843–53. https://doi.org/10.1016/S1473-3099(17)30242-6Wen X, Cao D, Jones RW, Li J, Szu S, Hoshino Y. Construction and characterization of human rotavirus recombinant VP8* subunit parenteral vaccine candidates. Vaccine. 2012;30(43):6121–6. https://doi.org/10.1016/j.vaccine.2012.07.078Wen X, Cao D, Jones RW, Li J, Szu S, Hoshino Y. Construction and characterization of human rotavirus recombinant VP8* subunit parenteral vaccine candidates. Vaccine. 2012;30(43):6121–6. https://doi.org/10.1016/j.vaccine.2012.07.078Angel J, Steele AD, Franco MA. Correlates of protection for rotavirus vaccines: possible alternative trial endpoints, opportunities, and challenges. Hum Vaccin Immunother. 2014;10(12):3659–71. https://doi.org/10.4161/hv.34361Angel J, Steele AD, Franco MA. Correlates of protection for rotavirus vaccines: possible alternative trial endpoints, opportunities, and challenges. Hum Vaccin Immunother. 2014;10(12):3659–71. https://doi.org/10.4161/hv.34361Holmgren J, Parashar UD, Plotkin S, Louis J, Ng SP, Desauziers E, et al. Correlates of protection for enteric vaccines. Vaccine. 2017;35(26):3355–63. https://doi.org/10.1016/j.vaccine.2017.05.005Holmgren J, Parashar UD, Plotkin S, Louis J, Ng SP, Desauziers E, et al. Correlates of protection for enteric vaccines. Vaccine. 2017;35(26):3355–63. https://doi.org/10.1016/j.vaccine.2017.05.005Desselberger U, Huppertz HI. Immune responses to rotavirus infection and vaccination and associated correlates of protection. J Infect Dis. 2011;203(2):188–95. https://doi.org/10.1093/infdis/jiq031Desselberger U, Huppertz HI. Immune responses to rotavirus infection and vaccination and associated correlates of protection. J Infect Dis. 2011;203(2):188–95. https://doi.org/10.1093/infdis/jiq031Velázquez FR, Matson DO, Guerrero ML, Shults J, Calva JJ, Morrow AL, et al. Serum antibody as a marker of protection against natural rotavirus infection and disease. J Infect Dis. 2000;182(6):1602–9. https://doi.org/10.1086/317619Velázquez FR, Matson DO, Guerrero ML, Shults J, Calva JJ, Morrow AL, et al. Serum antibody as a marker of protection against natural rotavirus infection and disease. J Infect Dis. 2000;182(6):1602–9. https://doi.org/10.1086/317619Patel M, Glass RI, Jiang B, Santosham M, Lopman B, Parashar U. A systematic review of anti-rotavirus serum IgA antibody titer as a potential correlate of rotavirus vaccine efficacy. J Infect Dis. 2013;208(2):284–94. https://doi.org/10.1093/infdis/jit166Patel M, Glass RI, Jiang B, Santosham M, Lopman B, Parashar U. A systematic review of anti-rotavirus serum IgA antibody titer as a potential correlate of rotavirus vaccine efficacy. J Infect Dis. 2013;208(2):284–94. https://doi.org/10.1093/infdis/jit166Lee B, Carmolli M, Dickson DM, Colgate ER, Diehl SA, Uddin MI, et al. Rotavirus-specific immunoglobulin A responses are impaired and serve as a suboptimal correlate of protection among infants in Bangladesh. Clin Infect Dis. 2018;67(2):186–92. https://doi.org/10.1093/cid/ciy076Lee B, Carmolli M, Dickson DM, Colgate ER, Diehl SA, Uddin MI, et al. Rotavirus-specific immunoglobulin A responses are impaired and serve as a suboptimal correlate of protection among infants in Bangladesh. Clin Infect Dis. 2018;67(2):186–92. https://doi.org/10.1093/cid/ciy076Liu GF, Hille D, Kaplan SS, Goveia MG. Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine. Hum Vaccin Immunother. 2017;13(10):2357–63. https://doi.org/10.1080/21645515.2017.1356522Liu GF, Hille D, Kaplan SS, Goveia MG. Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine. Hum Vaccin Immunother. 2017;13(10):2357–63. https://doi.org/10.1080/21645515.2017.1356522Jiang B, Gentsch JR, Glass RI. The role of serum antibodies in the protection against rotavirus disease: an overview. Clin Infect Dis. 2002;34(10):1351–61. https://doi.org/10.1086/340103Jiang B, Gentsch JR, Glass RI. The role of serum antibodies in the protection against rotavirus disease: an overview. Clin Infect Dis. 2002;34(10):1351–61. https://doi.org/10.1086/340103Blutt SE, Warfield KL, Lewis DE, Conner ME. Early response to rotavirus infection involves massive B cell activation. J Immunol. 2002;168(11):5716–21. https://doi.org/10.4049/jimmunol.168.11.5716Blutt SE, Warfield KL, Lewis DE, Conner ME. Early response to rotavirus infection involves massive B cell activation. J Immunol. 2002;168(11):5716–21. https://doi.org/10.4049/jimmunol.168.11.5716Wang Y, Dennehy PH, Keyserling HL, Tang K, Gentsch JR, Glass RI, Jiang B. Rotavirus infection alters peripheral T-cell homeostasis in children with acute diarrhea. J Virol. 2007;81(8):3904–12. https://doi.org/10.1128/JVI.01887-06Wang Y, Dennehy PH, Keyserling HL, Tang K, Gentsch JR, Glass RI, Jiang B. Rotavirus infection alters peripheral T-cell homeostasis in children with acute diarrhea. J Virol. 2007;81(8):3904–12. https://doi.org/10.1128/JVI.01887-06Ella R, Bobba R, Muralidhar S, Babji S, Vadrevu KM, Bhan MK. A Phase 4, multicentre, randomized, single-blind clinical trial to evaluate the immunogenicity of the live, attenuated, oral rotavirus vaccine (116E), ROTAVAC®, administered simultaneously with or without the buffering agent in healthy infants in India. Hum Vaccin Immunother. 2018;14(7):1791–9. https://doi.org/10.1080/21645515.2018.1450709Ella R, Bobba R, Muralidhar S, Babji S, Vadrevu KM, Bhan MK. A Phase 4, multicentre, randomized, single-blind clinical trial to evaluate the immunogenicity of the live, attenuated, oral rotavirus vaccine (116E), ROTAVAC®, administered simultaneously with or without the buffering agent in healthy infants in India. Hum Vaccin Immunother. 2018;14(7):1791–9. https://doi.org/10.1080/21645515.2018.1450709Gómez-Rial J, Curras-Tuala MJ, Talavero-González C, Rodríguez-Tenreiro C, Vilanova-Trillo L, Gómez-Carballa A, et al. Salivary epidermal growth factor correlates with hospitalization length in rotavirus infection. BMC Infect Dis. 2017;17:370. https://doi.org/10.1186/s12879-017-2463-0Gómez-Rial J, Curras-Tuala MJ, Talavero-González C, Rodríguez-Tenreiro C, Vilanova-Trillo L, Gómez-Carballa A, et al. Salivary epidermal growth factor correlates with hospitalization length in rotavirus infection. BMC Infect Dis. 2017;17:370. https://doi.org/10.1186/s12879-017-2463-0Jiang J, Jiang B, Parashar U, Nguyen T, Bines J, Patel MM. Childhood intussusception: a literature review. PloS One. 2013;8(7):e68482. https://doi.org/10.1371/journal.pone.0068482Jiang J, Jiang B, Parashar U, Nguyen T, Bines J, Patel MM. Childhood intussusception: a literature review. PloS One. 2013;8(7):e68482. https://doi.org/10.1371/journal.pone.0068482Mansour AM, El Koutby M, El Barbary MM, Mohamed W, Shehata S, El Mohammady H, et al. Enteric viral infections as potential risk factors for intussusception. J Infect Dev Ctries. 2013;7(1):28–35. https://doi.org/10.3855/jidc.2321Mansour AM, El Koutby M, El Barbary MM, Mohamed W, Shehata S, El Mohammady H, et al. Enteric viral infections as potential risk factors for intussusception. J Infect Dev Ctries. 2013;7(1):28–35. https://doi.org/10.3855/jidc.2321Clarke EJ Jr, Phillips IA, Alexander ER. Adenovirus infection in intussusception in children in Taiwan. JAMA. 1969;208(9):1671–4. https://doi.org/10.1001/jama.1969.03160090031007Clarke EJ Jr, Phillips IA, Alexander ER. Adenovirus infection in intussusception in children in Taiwan. JAMA. 1969;208(9):1671–4. https://doi.org/10.1001/jama.1969.03160090031007Minney-Smith CA, Levy A, Hodge M, Jacoby P, Williams SH, Carcione D, et al. Intussusception is associated with the detection of adenovirus C, enterovirus B and rotavirus in a rotavirus vaccinated population. J Clin Virol. 2014;61(4):579–84. https://doi.org/10.1016/j.jcv.2014.10.018Minney-Smith CA, Levy A, Hodge M, Jacoby P, Williams SH, Carcione D, et al. Intussusception is associated with the detection of adenovirus C, enterovirus B and rotavirus in a rotavirus vaccinated population. J Clin Virol. 2014;61(4):579–84. https://doi.org/10.1016/j.jcv.2014.10.018Nylund CM, Denson LA, Noel JM. Bacterial enteritis as a risk factor for childhood intussusception: a retrospective cohort study. J Pediatr. 2010;156(5):761–5. https://doi.org/10.1016/j.jpeds.2009.11.026Nylund CM, Denson LA, Noel JM. Bacterial enteritis as a risk factor for childhood intussusception: a retrospective cohort study. J Pediatr. 2010;156(5):761–5. https://doi.org/10.1016/j.jpeds.2009.11.026Weintraub ES, Baggs J, Duffy J, Vellozzi C, Belongia EA, Irving S, et al. Risk of intussusception after monovalent rotavirus vaccination. N Engl J Med. 2014;370(6):513–9. https://doi.org/10.1056/NEJMoa1311738Weintraub ES, Baggs J, Duffy J, Vellozzi C, Belongia EA, Irving S, et al. Risk of intussusception after monovalent rotavirus vaccination. N Engl J Med. 2014;370(6):513–9. https://doi.org/10.1056/NEJMoa1311738Tate JE, Mwenda JM, Armah G, Jani B, Omore R, Ademe A, et al. Evaluation of intussusception after monovalent rotavirus vaccination in Africa. N Engl J Med. 2018;378(16):1521–8. https://doi.org/10.1056/NEJMoa1713909Tate JE, Mwenda JM, Armah G, Jani B, Omore R, Ademe A, et al. Evaluation of intussusception after monovalent rotavirus vaccination in Africa. N Engl J Med. 2018;378(16):1521–8. https://doi.org/10.1056/NEJMoa1713909Дармостукова МА, Снегирева ИИ, Вельц НЮ, Казаков АС, Аляутдин РН. Международный мониторинг безопасности вакцин. Безопасность и риск фармакотерапии. 2019;7(1):6–14. https://doi.org/10.30895/2312-7821-2019-7-1-6-14Darmostukova MA, Snegireva II, Velts NYu, Kazakov AS, Alyautdin RN. Vaccine safety international monitoring. Bezopasnost’ i risk farmakoterapii = Safety and Risk of Pharmacotherapy. 2019;7(1):6–14 (In Russ.) https://doi.org/10.30895/2312-7821-2019-7-1-6-14Soares-Weiser K, Bergman H, Henschke N, Pitan F, Cunliffe N. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev. 2019;(3):CD008521. https://doi.org/10.1002/14651858.CD008521.pub4Soares-Weiser K, Bergman H, Henschke N, Pitan F, Cunliffe N. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev. 2019;(3):CD008521. https://doi.org/10.1002/14651858.CD008521.pub4Yen C, Healy K, Tate JE, Parashar UD, Bines J, Neuzil K, et al. Rotavirus vaccination and intussusception – science, surveillance, and safety: a review of evidence and recommendations for future research priorities in low and middle income countries. Hum Vaccin Immunother. 2016;12(10):2580–9. https://doi.org/10.1080/21645515.2016.1197452Yen C, Healy K, Tate JE, Parashar UD, Bines J, Neuzil K, et al. Rotavirus vaccination and intussusception – science, surveillance, and safety: a review of evidence and recommendations for future research priorities in low and middle income countries. Hum Vaccin Immunother. 2016;12(10):2580–9. https://doi.org/10.1080/21645515.2016.1197452Tate JE, Parashar UD. Approaches to monitoring intussusception following rotavirus vaccination. Expert Opin Drug Saf. 2019 ;18(1):21–7. https://doi.org/10.1080/14740338.2019.1561857Tate JE, Parashar UD. Approaches to monitoring intussusception following rotavirus vaccination. Expert Opin Drug Saf. 2019 ;18(1):21–7. https://doi.org/10.1080/14740338.2019.1561857Desselberger U. Differences of rotavirus vaccine effectiveness by country: likely causes and contributing factors. Pathogens. 2017;6(4):65. https://doi.org/10.3390/pathogens6040065Desselberger U. Differences of rotavirus vaccine effectiveness by country: likely causes and contributing factors. Pathogens. 2017;6(4):65. https://doi.org/10.3390/pathogens6040065Dennehy PH, Bertrand HR, Silas PE, Damaso S, Friedland LR, Abu-Elyazeed R. Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. Pediatrics. 2008;122(5):e1062–6. https://doi.org/10.1542/peds.2008-1059Dennehy PH, Bertrand HR, Silas PE, Damaso S, Friedland LR, Abu-Elyazeed R. Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. Pediatrics. 2008;122(5):e1062–6. https://doi.org/10.1542/peds.2008-1059Gruber JF, Gruber LM, Weber RP, Becker-Dreps S, Jonsson Funk M. Rotavirus vaccine schedules and vaccine response among infants in low- and middle-income countries: a systematic review. Open Forum Infect Dis. 2017;4(2):ofx066. https://doi.org/10.1093/ofid/ofx066Gruber JF, Gruber LM, Weber RP, Becker-Dreps S, Jonsson Funk M. Rotavirus vaccine schedules and vaccine response among infants in low- and middle-income countries: a systematic review. Open Forum Infect Dis. 2017;4(2):ofx066. https://doi.org/10.1093/ofid/ofx066Crawford SE, Ramani S, Tate JE, Parashar UD, Svensson L, Hagbom M, et al. Rotavirus infection. Nat Rev Dis Primers. 2017;3:17083. https://doi.org/10.1038/nrdp.2017.83Crawford SE, Ramani S, Tate JE, Parashar UD, Svensson L, Hagbom M, et al. Rotavirus infection. Nat Rev Dis Primers. 2017;3:17083. https://doi.org/10.1038/nrdp.2017.83Willame C, Vonk Noordegraaf-Schouten M, Gvozdenović E, Kochems K, Oordt-Speets A, Praet N, et al. Effectiveness of the oral human attenuated rotavirus vaccine: a systematic review and meta-analysis–2006–2016. Open Forum Infect Dis. 2018;5(11):ofy292. https://doi.org/10.1093/ofid/ofy292Willame C, Vonk Noordegraaf-Schouten M, Gvozdenović E, Kochems K, Oordt-Speets A, Praet N, et al. Effectiveness of the oral human attenuated rotavirus vaccine: a systematic review and meta-analysis–2006–2016. Open Forum Infect Dis. 2018;5(11):ofy292. https://doi.org/10.1093/ofid/ofy292Payne DC, Selvarangan R, Azimi PH, Boom JA, Englund JA, Staat MA, et al. Long-term consistency in rotavirus vaccine protection: RV5 and RV1 vaccine effectiveness in US children, 2012–2013. Clin Infect Dis. 2015;61(12):1792–9. https://doi.org/10.1093/cid/civ872Payne DC, Selvarangan R, Azimi PH, Boom JA, Englund JA, Staat MA, et al. Long-term consistency in rotavirus vaccine protection: RV5 and RV1 vaccine effectiveness in US children, 2012–2013. Clin Infect Dis. 2015;61(12):1792–9. https://doi.org/10.1093/cid/civ872Inchauste L, Patzi M, Halvorsen K, Solano S, Montesano R, Iñiguez V. Impact of rotavirus vaccination on child mortality, morbidity, and rotavirus-related hospitalizations in Bolivia. Int J Infect Dis. 2017;61:79–88. https://doi.org/10.1016/j.ijid.2017.06.006Inchauste L, Patzi M, Halvorsen K, Solano S, Montesano R, Iñiguez V. Impact of rotavirus vaccination on child mortality, morbidity, and rotavirus-related hospitalizations in Bolivia. Int J Infect Dis. 2017;61:79–88. https://doi.org/10.1016/j.ijid.2017.06.006Burnett E, Jonesteller CL, Tate JE, Yen C, Parashar UD. Global impact of rotavirus vaccination on childhood hospitalizations and mortality from diarrhea. J Infect Dis. 2017;215(11):1666–72. https://doi.org/10.1093/infdis/jix186Burnett E, Jonesteller CL, Tate JE, Yen C, Parashar UD. Global impact of rotavirus vaccination on childhood hospitalizations and mortality from diarrhea. J Infect Dis. 2017;215(11):1666–72. https://doi.org/10.1093/infdis/jix186Abou-Nader AJ, Sauer MA, Steele AD, Tate JE, Atherly D, Parashar UD, et al. Global rotavirus vaccine introductions and coverage: 2006–2016. Hum Vaccin Immunother. 2018;14(9):2281–96. https://doi.org/10.1080/21645515.2018.1470725Abou-Nader AJ, Sauer MA, Steele AD, Tate JE, Atherly D, Parashar UD, et al. Global rotavirus vaccine introductions and coverage: 2006–2016. Hum Vaccin Immunother. 2018;14(9):2281–96. https://doi.org/10.1080/21645515.2018.1470725Patel M, Shane AL, Parashar UD, Jiang B, Gentsch JR, Glass RI. Oral rotavirus vaccines: how well will they work where they are needed most? J Infect Dis. 2009;200(Suppl. 1):S39–48. https://doi.org/10.1086/605035Patel M, Shane AL, Parashar UD, Jiang B, Gentsch JR, Glass RI. Oral rotavirus vaccines: how well will they work where they are needed most? J Infect Dis. 2009;200(Suppl. 1):S39–48. https://doi.org/10.1086/605035Atherly DE, Lewis KDC, Tate J, Parashar UD, Rheingans RD. Projected health and economic impact of rotavirus vaccination in GAVI-eligible countries: 2011–2030. Vaccine. 2012;30(Suppl. 1):A7–14. https://doi.org/10.1016/j.vaccine.2011.12.096Atherly DE, Lewis KDC, Tate J, Parashar UD, Rheingans RD. Projected health and economic impact of rotavirus vaccination in GAVI-eligible countries: 2011–2030. Vaccine. 2012;30(Suppl. 1):A7–14. https://doi.org/10.1016/j.vaccine.2011.12.096Mwenda JM, Parashar UD, Cohen AL, Tate JE. Impact of rotavirus vaccines in Sub-Saharan African countries. Vaccine. 2018;36(47):7119–23. https://doi.org/10.1016/j.vaccine.2018.06.026Mwenda JM, Parashar UD, Cohen AL, Tate JE. Impact of rotavirus vaccines in Sub-Saharan African countries. Vaccine. 2018;36(47):7119–23. https://doi.org/10.1016/j.vaccine.2018.06.026Madhi SA, Cunliffe NA, Steele D, Witte D, Kirsten M, Louw C, et al. Effect of human rotavirus vaccine on severe diarrhea in African infants. N Engl J Med. 2010;362(4):289–98. https://doi.org/10.1056/NEJMoa0904797Madhi SA, Cunliffe NA, Steele D, Witte D, Kirsten M, Louw C, et al. Effect of human rotavirus vaccine on severe diarrhea in African infants. N Engl J Med. 2010;362(4):289–98. https://doi.org/10.1056/NEJMoa0904797Armah GE, Sow SO, Breiman RF, Dallas MJ, Tapia MD, Feikin DR, et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;376(9741):606–14. https://doi.org/10.1016/S0140-6736(10)60889-6Armah GE, Sow SO, Breiman RF, Dallas MJ, Tapia MD, Feikin DR, et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;376(9741):606–14. https://doi.org/10.1016/S0140-6736(10)60889-6Mwenda JM, Burke RM, Shaba K, Mihigo R, Tevi-Benissan MC, Mumba M, et al. Implementation of rotavirus surveillance and vaccine introduction – World Health Organization African Region, 2007–2016. MMWR Morb Mortal Wkly Rep. 2017;66(43):1192–6. https://doi.org/10.15585/mmwr.mm6643a7Mwenda JM, Burke RM, Shaba K, Mihigo R, Tevi-Benissan MC, Mumba M, et al. Implementation of rotavirus surveillance and vaccine introduction – World Health Organization African Region, 2007–2016. MMWR Morb Mortal Wkly Rep. 2017;66(43):1192–6. https://doi.org/10.15585/mmwr.mm6643a7

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