3,078
Views
0
CrossRef citations to date
0
Altmetric
Licensed Vaccines – Research Paper

A randomized trial assessing the efficacy, immunogenicity, and safety of vaccination with live attenuated varicella zoster virus-containing vaccines: ten-year follow-up in Russian children

, , , , , , , , , , , , , , , , , , ORCID Icon, & ORCID Icon on behalf of the show all, , , , , , , , , , , , & show all
Article: 1959148 | Received 01 Apr 2021, Accepted 18 Jul 2021, Published online: 26 Aug 2021

References

  • World Health Organization. Varicella and herpes zoster vaccines: WHO position paper, June 2014. Week Epidem Rec. 2014;89:265–12.
  • Varela FH, Pinto LA, Scotta MC. Global impact of varicella vaccination programs. Hum Vaccin Immunother. 2019;15(3):645–57. doi:10.1080/21645515.2018.1546525.
  • Thomas SL, Minassian C, Ganesan V, Langan SM, Smeeth L. Chickenpox and risk of stroke: a self-controlled case series analysis. Clin Infect Dis. 2014;58(1):61–68. doi:10.1093/cid/cit659.
  • Warren-Gash C, Forbes H, Breuer J. Varicella and herpes zoster vaccine development: lessons learned. Expert Rev Vaccines. 2017;16(12):1191–201. doi:10.1080/14760584.2017.1394843.
  • Gershon AA, Breuer J, Cohen JI, Cohrs RJ, Gershon MD, Gilden D, Grose C, Hambleton S, Kennedy PGE, Oxman MN, et al. Varicella zoster virus infection. Nat Rev Dis Primers. 2015;1(1):15016. doi:10.1097/INF.0000000000002233.
  • Federal Service for Supervision of Consumer Rights Protection and Human Well-Being. State report on the state of the sanitary-epidemiological well-being of the population in the Russian Federation in 2019.
  • Henry O, Brzostek J, Czajka H, Leviniene G, Reshetko O, Gasparini R, Pazdiora P, Plesca D, Desole MG, Kevalas R, et al. One or two doses of live varicella virus-containing vaccines: efficacy, persistence of immune responses, and safety six years after administration in healthy children during their second year of life. Vaccine. 2018;36(3):381–87. doi:10.1016/j.vaccine.2017.11.081.
  • Kuter B, Matthews H, Shinefield H, Black S, Dennehy P, Watson B, Reisinger K, Kim LL, Lupinacci L, Hartzel J, et al. Ten year follow-up of healthy children who received one or two injections of varicella vaccine. Pediatr Infect Dis J. 2004;23(2):132–37. doi:10.1097/01.inf.0000109287.97518.67.
  • Povey M, Henry O, Riise Bergsaker MA, Chlibek R, Esposito S, Flodmark C-E, Gothefors L, Man S, Silfverdal S-A, Štefkovičová M, et al. Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: 10-year follow-up of a phase 3 multicentre, observer-blind, randomised, controlled trial. Lancet Infect Dis. 2019;19(3):287–97. doi:10.1016/s1473-3099(18)30716-3.
  • Centers for Disease Control and Prevention. Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 1996;45:1–36.
  • Marin M, Güris D, Chaves SS, Schmid S, Seward JF. Prevention of varicella - Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2007;56:1–40.
  • Seward JF, Watson BM, Peterson CL, Mascola L, Pelosi JW, Zhang JX, Maupin TJ, Goldman GS, Tabony LJ, Brodovicz KG, et al. Varicella disease after introduction of varicella vaccine in the United States, 1995-2000. JAMA. 2002;287:606–11. doi:10.1001/jama.287.5.606.
  • Lopez AS, Zhang J, Brown C, Bialek S. Varicella-related hospitalizations in the United States, 2000-2006: the 1-dose varicella vaccination era. Pediatrics. 2011;127(2):238–45. doi:10.1542/peds.2010-0962.
  • Davis MM. Successes and remaining challenges after 10 years of varicella vaccination in the USA. Expert Rev Vaccines. 2006;5(2):295–302. doi:10.1586/14760584.5.2.295.
  • Quian J, Ruttimann R, Romero C, Dall’Orso P, Cerisola A, Breuer T, Greenberg M, Verstraeten T. Impact of universal varicella vaccination on 1-year-olds in Uruguay: 1997-2005. Arch Dis Child. 2008;93(10):845–50. doi:10.1136/adc.2007.126243.
  • Spoulou V, Alain S, Gabutti G, Giaquinto C, Liese J, Martinon-Torres F, Vesikari T. Implementing universal varicella vaccination in Europe: the path forward. Pediatr Infect Dis J. 2019;38(2):181–88. doi:10.1097/INF.0000000000002233.
  • Kuter BJ, Weibel RE, Guess HA, Matthews H, Morton DH, Neff BJ, Provost PJ, Watson BA, Starr SE, Plotkin SA. Oka/Merck varicella vaccine in healthy children: final report of a 2-year efficacy study and 7-year follow-up studies. Vaccine. 1991;9(9):643–47. doi:10.1016/0264-410x(91)90189-d.
  • Varis T, Vesikari T. Efficacy of high-titer live attenuated varicella vaccine in healthy young children. J Infect Dis. 1996;174(Suppl 3):S330–334. doi:10.1093/infdis/174.supplement_3.s330.
  • Marin M, Meer HC, Seward JF. Varicella prevention in the United States: a review of successes and challenges. Pediatrics. 2008;122(3):e744–751. doi:10.1542/peds.2008-0567.
  • Wutzler P, Bonanni P, Burgess M, Gershon A, Safadi MA, Casabona G. Varicella vaccination - the global experience. Expert Rev Vaccines. 2017;16(8):833–43. doi:10.1080/14760584.2017.1343669.
  • Yin M, Xu X, Liang Y, Ni J. Effectiveness, immunogenicity and safety of one vs. two-dose varicella vaccination: a meta-analysis. Expert Rev Vaccines. 2018;17(4):351–62. doi:10.1080/14760584.2018.1433999.
  • Kurugol Z, Gokce S. Outbreak of varicella in preschool children despite one-dose vaccination. Turk J Pediatr. 2018;60:56–62. doi:10.24953/turkjped.2018.01.008.
  • Spackova M, Wiese-Posselt M, Dehnert M, Matysiak-Klose D, Heininger U, Siedler A. Comparative varicella vaccine effectiveness during outbreaks in day-care centres. Vaccine. 2010;28(3):686–91. doi:10.1016/j.vaccine.2009.10.086.
  • Cheng HY, Chang LY, Lu CY, Huang LM. Epidemiology of breakthrough varicella after the implementation of a universal varicella vaccination program in Taiwan, 2004-2014. Sci Rep. 2018;8(1):17192. doi:10.1038/s41598-018-35451-y.
  • Tafuri S, Martinelli D, De Palma M, Germinario C, Prato R. Report of varicella outbreak in a low vaccination coverage group of otherwise healthy children in Italy: the role of breakthrough and the need of a second dose of vaccine. Vaccine. 2010;28(6):1594–97. doi:10.1016/j.vaccine.2009.11.047.
  • Kurugol Z, Halicioglu O, Koc F, Koturoglu G, Aksit S. Varicella rates among unvaccinated and one-dose vaccinated healthy children in Izmir, Turkey. Int J Infect Dis. 2011;15(7):e475–480. doi:10.1016/j.ijid.2011.03.016.
  • Macartney K. Prevention of varicella: time for two-dose vaccination. Lancet. 2014;383(9925):1276–77. doi:10.1016/s0140-6736(14)60078-7.
  • Marin M, Marti M, Kambhampati A, Jeram SM, Seward JF. Global varicella vaccine effectiveness: a meta-analysis. Pediatrics. 2016;137(3):e20153741. doi:10.1542/peds.2015-3741.
  • Ministry of Health of the Russian Federation. [Varilrix - Registration certificate] (Russian); 2019 [accessed 2020 June 11]. http://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=00437fd1-ba5c-4f78-8b06-e8e57dc373f6&t
  • State Register of Medicines. [Varivax Registration Certificate] (Russian); 2020 [accessed 2020 September 16]. http://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=a4bc173d-4610-48cb-9077-126a338414ca&t=
  • Ministry of Justice of the Russian Federation. [SP 3.1.3525-18Sanitary rules to prevent varicella & herpes zoster in Russian Federation] (Russian); 2018 [accessed 2020 June 11]. http://docs.cntd.ru/document/557220394
  • Vishneva EA, Kostinov MP, Mazankova LN, Malinnikova EY, Namazova-Baranova LS, Plakida AV, Privalova TE, Rtishchev AY, Tatochenko VK, Fedoseenko MV, et al. [Resolution of the expert forum of Russian Federation “Chickenpox: serious infection in Russian Federation, which can be prevented due to vaccination”] (Russian). Curr Pediatrics. 2019;18:491–94.
  • World Health Organization. WHO vaccine-preventable diseases: monitoring system. 2019 global summary [accessed 2020 March 17]. http://apps.who.int/immunization_monitoring/globalsummary/countries?countrycriteria%5Bcountry%5D%5B%5D=RUS
  • Baryshev MA, Chernyavskaya OP, Saltykova TS. Experience of the Varicella vaccine introduction into regional vaccination Schedule of the Russian Federation. Epidemiol Vacc Prev. 2020;18(6):67–74. doi:10.31631/2073-3046-2019-18-6-67-74.
  • Afonina NM, Mikheeva IV. [Efficacy of vaccine prophylaxis of varicella using different tactics for its carrying out] (Russian). Epidemio Infect Dis. 2019;1:29–36.
  • Prymula R, Bergsaker MR, Esposito S, Gothefors L, Man S, Snegova N, Štefkovičova M, Usonis V, Wysocki J, Douha M, et al. Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine versus one dose of monovalent varicella vaccine: a multicentre, observer-blind, randomised, controlled trial. Lancet. 2014;383(9925):1313–24. doi:10.1016/s0140-6736(12)61461-5.
  • Carryn S, Feyssaguet M, Povey M, Di Paolo E. Long-term immunogenicity of measles, mumps and rubella-containing vaccines in healthy young children: a 10-year follow-up. Vaccine. 2019;37(36):5323–31. doi:10.1016/j.vaccine.2019.07.049.
  • Ministry of Health of the Russian Federation. [Appendix N 1. National calendar of preventive vaccinations] (Russian); 2014 [accessed 2020 August 17]. https://base.garant.ru/70647158/53f89421bbdaf741eb2d1ecc4ddb4c33/
  • [Decree of the President of the Russian Federation of 06.06.2019 N 254 ”On the strategy for the development of healthcare in the Russian Federation for the period until 2025”] (Russian); 2019 [accessed 2021 January 19]. http://www.consultant.ru/document/cons_doc_LAW_326419/
  • Forum of Experts of the Russian Federation. [Varicella is a serious infectious threat for Russia which is vaccine-preventable] (Russian). Iss Modern Pediat. 2019;18:491–94.
  • GSK. Priorix-Tetra. Summary of product characteristics; 2017 [accessed 2020 March 19]. https://gskpro.com/content/dam/global/hcpportal/en_MT/PDF/Homepage/Products/productlisting/priorix-tetra/Priorix_Tetra_PI_II_078_18_Apr_2017.pdf
  • GSK. Varilrix. Summary of product characteristics; 2020 [accessed 2020 March 19]. https://www.medicines.org.uk/emc/medicine/9787
  • Vazquez M, LaRussa PS, Gershon AA, Steinberg SP, Freudigman K, Shapiro ED. The effectiveness of the varicella vaccine in clinical practice. N Engl J Med. 2001;344(13):955–60. doi:10.1056/NEJM200103293441302.
  • Cox DR. Regression models and life-tables. J Royal Statist Soc Ser B. 1972;34:187–220.
  • Gillard P, Povey M, Carryn S. Clinically- versus serologically-identified varicella: a hidden infection burden. A ten-year follow-up from a randomized study in varicella-endemic countries. Hum Vaccin Immunother. 2021:1–10. doi:10.1080/21645515.2021.1932217.
  • Bonanni P, Gershon A, Gershon M, Kulcsar A, Papaevangelou V, Rentier B, Sadzot-Delvaux C, Usonis V, Vesikari T, Weil-Olivier C, et al. Primary versus secondary failure after varicella vaccination: implications for interval between 2 doses. Pediatr Infect Dis J. 2013;32(7):e305–313. doi:10.1097/INF.0b013e31828b7def.
  • Bonanni P, Breuer J, Gershon A, Gershon M, Hryniewicz W, Papaevangelou V, Rentier B, Rumke H, Sadzot-Delvaux C, Senterre J, et al. Varicella vaccination in Europe – taking the practical approach. BMC Med. 2009;7(1):26. doi:10.1186/1741-7015-7-26.
  • Bayer O, Heininger U, Heiligensetzer C, von Kries R. Metaanalysis of vaccine effectiveness in varicella outbreaks. Vaccine. 2007;25(37–38):6655–60. doi:10.1016/j.vaccine.2007.07.010.
  • Klein NP, Abu-Elyazeed R, Povey M, Macias Parra M, Diez-Domingo J, Ahonen A, Korhonen T, Tinoco J-C, Weiner L, Marshall GS, et al. Immunogenicity and safety of a measles-mumps-rubella vaccine administered as a first dose to children aged 12 to 15 months: a phase III, randomized, noninferiority, lot-to-lot consistency study. J Pediatric Infect Dis Soc. 2020;9(2):194–201. doi:10.1093/jpids/piz010.
  • Prymula R, Simko R, Povey M, Kulcsar A. Varicella vaccine without human serum albumin versus licensed varicella vaccine in children during the second year of life: a randomized, double-blind, non-inferiority trial. BMC Pediatr. 2016;16(1):7. doi:10.1186/s12887-016-0546-5.
  • Habib MA, Prymula R, Carryn S, Esposito S, Henry O, Ravault S, Usonis V, Wysocki J, Gillard P, Povey M. Correlation of protection against varicella in a randomized Phase III varicella-containing vaccine efficacy trial in healthy infants. Vaccine. 2021;39(25):3445–54. doi:10.1016/j.vaccine.2021.02.074.
  • Ma S-J, Li X, Xiong Y-Q, Yao A-L, Chen Q. Combination measles-mumps-rubella-varicella vaccine in healthy children: a systematic review and meta-analysis of immunogenicity and safety. Medicine. 2015;94(44):e1721. doi:10.1097/MD.0000000000001721.
  • Klein NP, Fireman B, Yih WK, Lewis E, Kulldorff M, Ray P, Baxter R, Hambidge S, Nordin J, Naleway A, et al. Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures. Pediatrics. 2010;126(1):e1–8. doi:10.1542/peds.2010-0665.
  • Shamsheva OV. [Regional immunisation schedules as a step forward in prophylactic work in Russia. Experience of foreign countries.] (Russian). Pediatric Infect J. 2010;4:4–9.