<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE root>
<article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:ali="http://www.niso.org/schemas/ali/1.0/" article-type="other" dtd-version="1.2" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">Russian Journal of Infection and Immunity</journal-id><journal-title-group><journal-title xml:lang="en">Russian Journal of Infection and Immunity</journal-title><trans-title-group xml:lang="ru"><trans-title>Инфекция и иммунитет</trans-title></trans-title-group></journal-title-group><issn publication-format="print">2220-7619</issn><issn publication-format="electronic">2313-7398</issn><publisher><publisher-name xml:lang="en">SPb RAACI</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">1297</article-id><article-id pub-id-type="doi">10.15789/2220-7619-SOD-1297</article-id><article-categories><subj-group subj-group-type="toc-heading" xml:lang="en"><subject>REVIEWS</subject></subj-group><subj-group subj-group-type="toc-heading" xml:lang="ru"><subject>ОБЗОРЫ</subject></subj-group><subj-group subj-group-type="article-type"><subject></subject></subj-group></article-categories><title-group><article-title xml:lang="en">Safety of dengue vaccine (CYD-TDV) in Asia: a systematic review</article-title><trans-title-group xml:lang="ru"><trans-title>Безопасность вакцины от лихорадки денге (CYD-TDV) в Азии: систематический обзор</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Wan Ismail</surname><given-names>W. R.</given-names></name><name xml:lang="ru"><surname>Ван Исмаил</surname><given-names>В. Р.</given-names></name></name-alternatives><address><country country="MY">Malaysia</country></address><bio xml:lang="en"><p>Doctor of Public Health, Department of Community Health, National University of Malaysia.</p><p>Kuala Lumpur.</p></bio><bio xml:lang="ru"><p>Доктор санитарии и общественной гигиены, кафедра здравоохранения.</p><p>56000, Куала-Лумпур.</p></bio><email>drwanros@yahoo.com</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Abdul Majid</surname><given-names>M. Sh.</given-names></name><name xml:lang="ru"><surname>Абдул Маджид</surname><given-names>М. Ш.</given-names></name></name-alternatives><address><country country="MY">Malaysia</country></address><bio xml:lang="en"><p>Doctor of Public Health, Department of Community Health, National University of Malaysia.</p><p>Kuala Lumpur.</p></bio><bio xml:lang="ru"><p>Доктор санитарии и общественной гигиены, кафедра здравоохранения.</p><p>56000, Куала-Лумпур.</p></bio><email>uranium1987@gmail.com</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Li</surname><given-names>H. Y.</given-names></name><name xml:lang="ru"><surname>Ли</surname><given-names>Х. Ю.</given-names></name></name-alternatives><address><country country="MY">Malaysia</country></address><bio xml:lang="en"><p>Master of Community Health Science, Department of Community Health, National University of Malaysia.</p><p>Kuala Lumpur.</p></bio><bio xml:lang="ru"><p>Магистр социального здравоохранения, кафедра здравоохранения.</p><p>56000, Куала-Лумпур.</p></bio><email>amanda.hua53@gmail.com</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Madrim</surname><given-names>M. F.</given-names></name><name xml:lang="ru"><surname>Мадрим</surname><given-names>М. Ф.</given-names></name></name-alternatives><address><country country="MY">Malaysia</country></address><bio xml:lang="en"><p>Doctor of Public Health, Lecturer, Department of Community and Family Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.</p><p>Kota Kinabalu.</p></bio><bio xml:lang="ru"><p>Доктор санитарии и общественной гигиены, преподаватель кафедры общественной и семейной медицины, факультет медицины и медико-санитарных дисциплин.</p><p>Кота-Кинабалу.</p></bio><email>faizalmadrim@gmail.com</email><xref ref-type="aff" rid="aff2"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Abdul Rahim</surname><given-names>S.Sh. S.</given-names></name><name xml:lang="ru"><surname>Абдул Рахим</surname><given-names>С. Ш.</given-names></name></name-alternatives><address><country country="MY">Malaysia</country></address><bio xml:lang="en"><p>Doctor of Public Health, Head of the Department of Community and Family Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.</p><p>Kota Kinabalu.</p></bio><bio xml:lang="ru"><p>Доктор санитарии и общественной гигиены, зав. кафедрой общественной и семейной медицины, факультет медицины и медико-санитарных дисциплин.</p><p>Кота-Кинабалу.</p></bio><email>syedsharizman@ums.edu.my</email><xref ref-type="aff" rid="aff2"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Jeffree</surname><given-names>M. S.</given-names></name><name xml:lang="ru"><surname>Джеффри</surname><given-names>М. С.</given-names></name></name-alternatives><address><country country="MY">Malaysia</country></address><bio xml:lang="en"><p>Master of Community Medicine, Professor, Department of Community and Family Medicine, Dean of the Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.</p><p>Kota Kinabalu.</p></bio><bio xml:lang="ru"><p>Магистр социальной медицины, преподаватель кафедры общественной и семейной медицины, декан факультета медицины и медико-санитарных дисциплин.</p><p>Кота-Кинабалу.</p></bio><email>saffree@ums.edu.my</email><xref ref-type="aff" rid="aff2"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Azhar</surname><given-names>Z. I.</given-names></name><name xml:lang="ru"><surname>Азар</surname><given-names>З. И.</given-names></name></name-alternatives><address><country country="MY">Malaysia</country></address><bio xml:lang="en"><p>Doctor of Public Health, Lecturer, Department of Public Health Medicine, Faculty of Medicine, Universiti Teknologi MARA.</p><p>Shah Alam.</p></bio><bio xml:lang="ru"><p>Доктор санитарии и общественной гигиены, преподаватель кафедры медицины здравоохранения, факультет медицины.</p><p>Шах-Алам.</p></bio><email>drzahir@uitm.edu.my</email><xref ref-type="aff" rid="aff3"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Ghazi</surname><given-names>H. F.</given-names></name><name xml:lang="ru"><surname>Гази</surname><given-names>Х. Ф.</given-names></name></name-alternatives><address><country country="IQ">Iraq</country></address><bio xml:lang="en"><p>Associate Professor, College of Nursing, Al-Bayan University.</p><p>Baghdad.</p></bio><bio xml:lang="ru"><p>Кандидат наук, доцент, Колледж по подготовке среднего медицинского персонала.</p><p>Багдад.</p></bio><email>dr.hasanainhabasha@gmail.com</email><xref ref-type="aff" rid="aff4"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Hassan</surname><given-names>M. R.</given-names></name><name xml:lang="ru"><surname>Хассан</surname><given-names>М. Р.</given-names></name></name-alternatives><address><country country="MY">Malaysia</country></address><bio xml:lang="en"><p>Mohd Rohaizat Hassan - PhD, Head of the Department of Community Health, National University of Malaysia.</p><p>Jalan Yaacob Latiff, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur.</p></bio><bio xml:lang="ru"><p>Мохд Рохайзат Хассан - кандидат наук, заведующий кафедрой здравоохранения.</p><p>56000, Куала-Лумпур, Бандар Тун Разак, Джалан Яакоб Латиф.</p></bio><email>rohaizat@ppukm.ukm.edu.my</email><xref ref-type="aff" rid="aff1"/></contrib></contrib-group><aff-alternatives id="aff1"><aff><institution xml:lang="en">National University of Malaysia</institution></aff><aff><institution xml:lang="ru">Национальный университет Малайзии</institution></aff></aff-alternatives><aff-alternatives id="aff2"><aff><institution xml:lang="en">Universiti Malaysia Sabah</institution></aff><aff><institution xml:lang="ru">Малайзиский университет штата Сабах</institution></aff></aff-alternatives><aff-alternatives id="aff3"><aff><institution xml:lang="en">Universiti Teknologi MARA</institution></aff><aff><institution xml:lang="ru">Технологический университет MARA</institution></aff></aff-alternatives><aff-alternatives id="aff4"><aff><institution xml:lang="en">College of Nursing, Al-Bayan University</institution></aff><aff><institution xml:lang="ru">Колледж по подготовке среднего медицинского персонала, Университет Аль-Баян</institution></aff></aff-alternatives><pub-date date-type="pub" iso-8601-date="2021-06-23" publication-format="electronic"><day>23</day><month>06</month><year>2021</year></pub-date><volume>11</volume><issue>3</issue><issue-title xml:lang="en"/><issue-title xml:lang="ru"/><fpage>447</fpage><lpage>453</lpage><history><date date-type="received" iso-8601-date="2019-11-05"><day>05</day><month>11</month><year>2019</year></date><date date-type="accepted" iso-8601-date="2020-03-14"><day>14</day><month>03</month><year>2020</year></date></history><permissions><copyright-statement xml:lang="en">Copyright ©; 2020, Wan Ismail W.R., Abdul Majid M.S., Li H.Y., Madrim M.F., Abdul Rahim S.S., Jeffree M.S., Azhar Z.I., Ghazi H.F., Hassan M.R.</copyright-statement><copyright-statement xml:lang="ru">Copyright ©; 2020, Ван Исмаил В.Р., Абдул Маджид М.Ш., Ли Х.Ю., Мадрим М.Ф., Абдул Рахим С.Ш., Джеффри М.С., Азар З.И., Гази Х.Ф., Хассан М.Р.</copyright-statement><copyright-year>2020</copyright-year><copyright-holder xml:lang="en">Wan Ismail W.R., Abdul Majid M.S., Li H.Y., Madrim M.F., Abdul Rahim S.S., Jeffree M.S., Azhar Z.I., Ghazi H.F., Hassan M.R.</copyright-holder><copyright-holder xml:lang="ru">Ван Исмаил В.Р., Абдул Маджид М.Ш., Ли Х.Ю., Мадрим М.Ф., Абдул Рахим С.Ш., Джеффри М.С., Азар З.И., Гази Х.Ф., Хассан М.Р.</copyright-holder><ali:free_to_read xmlns:ali="http://www.niso.org/schemas/ali/1.0/"/><license><ali:license_ref xmlns:ali="http://www.niso.org/schemas/ali/1.0/">https://creativecommons.org/licenses/by/4.0</ali:license_ref></license></permissions><self-uri xlink:href="https://iimmun.ru/iimm/article/view/1297">https://iimmun.ru/iimm/article/view/1297</self-uri><abstract xml:lang="en"><p>The use of the vaccine in Asia is still very much limited and remained controversial due to its safety, which has yet been properly assessed and evaluated. Hence, the objective of this review is to assess the safety of the CYD-TDV dengue vaccine of the efficacy trials conducted in Asia. A total of 309 related articles were generated from the electronic database search using relevant keywords and only four of the articles were selected for the final review process. The seroprevalence at baseline of the participants involved in the studies was between 50 percent and 80 percent. In terms of the safety of the CYD-TDV vaccine, injection site reaction (pain, swelling, erythema) recorded a relative risk (RR) at 95% CI of (0.46—1.76) and systemic reactions (fever, headache, myalgia) also with RR at 95% CI of (0.89—1.81) were detected among the participants. Among the four studies reviewed, three studies reported some severe adverse effect experienced by the participants with RR at 95% CI of (0.92—2.11). In terms of the immunogenicity, high GMT values were reported for DENV-2 at 67.8 (95%CI of 64.8-70.8), DENV-3 at 73.1 (95% CI of 69.9-76.3) and DENV-4 at 65 (95%CI of 62-67.9) where even though lower values were reported it is consistent with other published studies on the immunogenicity of the CYD-TDV against the DENV serotypes. This review showed that the CYD-TDV can be considered for use in Asia, but with several conditions and following current safety recommendations.</p></abstract><trans-abstract xml:lang="ru"><p>Применение вакцины от лихорадки денге (CYD-TDV) в Азии в настоящее время остается достаточно ограниченным и противоречивым из-за вопросов безопасности, пока остающихся не оцененными должным образом. В связи с этим, целью нашего обзора стало проведение оценки безопасности вакцины CYD-TDV на основее анализа данных по эффективности ее применения в Азии. Поиск релевантных ключевых слов в электронных базах данных обнаружил 309 научных статей, из которых в обзор вошли лишь четыре публикации. Исходная распространенность серотипов среди участников исследований составляла 50—80%. В отношении безопасности вакцины CYD-TDV показано, что реакция в месте введения (боль, отек, эритема) отмечена с относительным риском (RR) 95% ДИ (0,46—1,76), как и системные реакции (лихорадка, головная боль, миалгия) [95% ДИ (0,89—1,81)]. Из четырех работ, включенных в обзор, три содержат данные о ряде тяжелых неблагополучных эффектов при RR 95% ДИ (0,92—2,11). В отношении иммуногенности показано, что для DENV-2 отмечено высокое среднее геометрическое значение титра в 67,8 (95% ДИ 64,8—70,8), DENV-3 — в 73,1 (95% ДИ 69,9-76,3), а для DENV-4 — в 65 (95% ДИ 62-67,9), когда при обнаружении даже меньших величин это согласуется с другими опубликованными работами по иммуногенности вакцины CYD-TDV в отношении серотипов DENV. В нашем обзоре показано, что вакцина CYD-TDV может рассматриваться для применения в Азии, но с учетом ряда условий и выполнения настоящих рекомендаций по безопасности.</p></trans-abstract><kwd-group xml:lang="en"><kwd>Dengue vaccine</kwd><kwd>CYD-TDV</kwd><kwd>safety</kwd><kwd>adults</kwd><kwd>children</kwd><kwd>Asia</kwd></kwd-group><kwd-group xml:lang="ru"><kwd>вакцина от лихорадки Денге</kwd><kwd>CYD-TDV</kwd><kwd>безопасность</kwd><kwd>взрослые</kwd><kwd>дети</kwd><kwd>Азия</kwd></kwd-group><funding-group><funding-statement xml:lang="en">We would like to acknowledge the Director General Ministry of Health Malaysia and University Kebangsaan Malaysia for allowing publication of this review.</funding-statement></funding-group></article-meta></front><body></body><back><ref-list><ref id="B1"><label>1.</label><mixed-citation>1.	Aguiar M., Stollenwerk N., Halstead S.B. The Impact of the newly licensed dengue vaccine in endemic countries. PLoS Negl. Trop. Dis., 2016, vol. 10, no. 12: e0005179. doi: 10.1371/journal.pntd.0005179</mixed-citation></ref><ref id="B2"><label>2.</label><mixed-citation>2.	Bhatt S., Gething P.W., Brady O.J., Messina J.P., Farlow A.W., Moyes C.L., Drake J.M., Brownstein J.S., Hoen A.G., Sankoh O., Myers M.F., George D.B., Jaenisch T., Wint G.R., Simmons C.P., Scott T.W., Farrar J.J., Hay S.I. The global distribution and burden of dengue. Nature, 2013, vol. 496, no. 7446, pp. 504—507. doi: 10.1038/nature12060</mixed-citation></ref><ref id="B3"><label>3.</label><mixed-citation>3.	Capeding M.R., Laot T.M., Boaz M., Wartel T.A., Crevat D. Immunogenicity and safety of a tetravalent dengue vaccine during a five-year follow-up period. Trials Vaccinol., 2015, vol. 4, pp. 19—23. doi: 10.1016/j.trivac.2015.03.002</mixed-citation></ref><ref id="B4"><label>4.</label><mixed-citation>4.	Capeding M.R., Tran N.H., Hadinegoro S.R., Ismail H.I., Chotpitayasunondh T., Chua M.N., Luong C.Q., Rusmil K., Wirawan D.N., Nallusamy R., Pitisuttithum P., Thisyakorn U., Yoon I.K., van der Vliet D., Langevin E., Laot T., Hutagalung Y., Frago C., Boaz M., Wartel T.A., Tornieporth N.G., Saville M., Bouckenooghe A.; CYD14 Study Group. Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial. Lancet, 2014, vol. 384, no. 9951,pp. 1358-1365. doi: 10.1016/S0140--6736(14)61060--6</mixed-citation></ref><ref id="B5"><label>5.</label><mixed-citation>5.	Coudeville L., Baurin N., Vergu E. Estimation of parameters related to vaccine efficacy and dengue transmission from two large phase III studies. Vaccine, 2016, vol. 34, no. 50, pp. 6417-6425. doi: 10.1016/j.vaccine.2015.11.023</mixed-citation></ref><ref id="B6"><label>6.</label><mixed-citation>6.	Crevat D., Brion J.D., Gailhardou S., Laot T.M., Capeding M.R. First experience of concomitant vaccination against dengue and MMR in toddlers. Pediatr. Infect. Dis. J., 2015, vol. 34, no. 8, pp. 884-892. doi: 10.1097/INF.0000000000000752</mixed-citation></ref><ref id="B7"><label>7.</label><mixed-citation>7.	Da Costa V.G., Marques-Silva A.C., Floriano V.G., Moreli M.L. Safety, immunogenicity and efficacy of a recombinant tetravalent dengue vaccine: a meta-analysis of randomized trials. Vaccine, 2014, vol. 32, no. 39, pp. 4885-4892. doi: 10.1016/j.vaccine.2014.07.008</mixed-citation></ref><ref id="B8"><label>8.</label><mixed-citation>8.	Guy B., Jackson N. Dengue vaccine: hypotheses to understand CYD-TDV-induced protection. Nat. Rev. Microbiol., 2015, vol. 14, pp. 45-54. doi: 10.1038/nrmicro.2015.2</mixed-citation></ref><ref id="B9"><label>9.</label><mixed-citation>9.	Hss A.S., Koh M.T., Tan K.K., Chan L.G., Zhou L., Bouckenooghe A., Crevat D., Hutagalung Y. Safety and immunogenicity of a tetravalent dengue vaccine in healthy children aged 2—11 years in Malaysia: a randomized, placebo-controlled, Phase III study. Vaccine, 2013, vol. 31, no. 49, pp. 5814-5821. doi: 10.1016/j.vaccine.2013.10.013</mixed-citation></ref><ref id="B10"><label>10.</label><mixed-citation>10.	Leo Y.S., Wilder-Smith A., Archuleta S., Shek L.P., Chong C-Y, Leong H.N., Low C.Y., Oh M.-L.H., Bouckenooghe A., Wartel T.A., Crevat D. Immunogenicity and safety of recombinant tetravalent dengue vaccine (CYD-TDV) in individuals aged 2—45 y: Phase II randomized controlled trial in Singapore. Hum. Vaccin. Immunother., 2012, vol. 8, no. 9, pp. 1259-1271. doi: 10.4161/hv.21224</mixed-citation></ref><ref id="B11"><label>11.</label><mixed-citation>11.	Malisheni M., Khaiboullina S.F., Rizvanov A.A., Takah N., Murewanhema G., Bates M. Clinical efficacy, safety, and immunogenicity of a live attenuated tetravalent dengue vaccine (CYD-TDV) in children: a systematic review with meta-analysis. Front. Immunol., 2017, vol. 8: 863. doi: 10.3389/fimmu.2017.00863</mixed-citation></ref><ref id="B12"><label>12.</label><mixed-citation>12.	Mustafa M.S., Rasotgi V., Jain S., Gupta V. Discovery of fifth serotype of dengue virus (DENV-5): a new public health dilemma in dengue control. Med. J. Armed Forces India, 2015, vol. 71, no. 1, pp. 67—70. doi: 10.1016/j.mjafi.2014.09.011</mixed-citation></ref><ref id="B13"><label>13.</label><mixed-citation>13.	Rainwater-Lovett K., Rodriguez-Barraquer I., Cummings D.A.T., Lessler J. Variation in dengue virus plaque reduction neutralization testing: systematic review and pooled analysis. BMC Infect. Dis., 2012, vol. 12, no. 1: 233. doi: 10.1186/1471-2334-12-233</mixed-citation></ref><ref id="B14"><label>14.</label><mixed-citation>14.	ReviewManager (RevMan). Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014. URL: https://training.cochrane.org/online-learning/core-software-cochrane-reviews/revman</mixed-citation></ref><ref id="B15"><label>15.</label><mixed-citation>15.	Tang K.F., Ooi E.E. Diagnosis of dengue: an update. Expert Rev. Anti Infect. Ther, 2012, vol. 10, no. 8, pp. 895—907. doi: 10.1586/eri.12.76</mixed-citation></ref><ref id="B16"><label>16.</label><mixed-citation>16.	Thomas S.J., Nisalak A., Anderson K.B., Libraty D.H., Kalayanarooj S., Vaughn D.W., Putnak R., Gibbons R.V., Jarman R., Endy T.P. Dengue plaque reduction neutralization test (PRNT) in primary and secondary dengue virus infections: how alterations in assay conditions impact performance. Am. J. Trop. Med. Hyg, 2009, vol. 81, no. 5, pp. 825—833. doi: 10.4269/ajt-mh.2009.08-0625</mixed-citation></ref><ref id="B17"><label>17.</label><mixed-citation>17.	Tran N.H., Luong C.Q., Vu T.Q.H., Forrat R., Lang J., Vu Q.D., Bouckenooghe A., Wartel T.A. Safety and immunogenicity of recombinant, live attenuated tetravalent dengue vaccine (CYD-TDV) in healthy vietnamese adults and children. J. Vaccines Vaccin., 2012, vol. 3, iss. 7: 1000162. doi: 10.4172/2157-7560.1000162</mixed-citation></ref><ref id="B18"><label>18.</label><mixed-citation>18.	WHO. Dengue: guidelines for diagnosis, treatment, prevention and control: new edition. Geneva: WHO, 2009. 147p.</mixed-citation></ref><ref id="B19"><label>19.</label><mixed-citation>19.	WHO. Revised SAGE recommendation on use of dengue vaccine. Geneva: WHO, 2018. URL: http://www.who.int/immunization/diseases/dengue/revised_SAGE_recommendations_dengue_vaccines_apr2018/en</mixed-citation></ref></ref-list></back></article>
