Инфекция и иммунитет. 2021; 11: 447-453
Безопасность вакцины от лихорадки денге (CYD-TDV) в Азии: систематический обзор
https://doi.org/10.15789/2220-7619-SOD-1297Аннотация
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.
Список литературы
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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
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Russian Journal of Infection and Immunity. 2021; 11: 447-453
Safety of dengue vaccine (CYD-TDV) in Asia: a systematic review
https://doi.org/10.15789/2220-7619-SOD-1297Abstract
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.
References
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
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
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
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
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
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
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
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
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
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
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
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
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
14. ReviewManager (RevMan). Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014. URL: https://training.cochrane.org/online-learning/core-software-cochrane-reviews/revman
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
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
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
18. WHO. Dengue: guidelines for diagnosis, treatment, prevention and control: new edition. Geneva: WHO, 2009. 147p.
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
