Phase 3, open-label, Russian, multicenter, single-arm trial to evaluate the immunogenicity of varicella vaccine (VARIVAX™) in healthy infants, children, and adolescents

References

• Papaloukas O, Giannouli G, Papaevangelou V. Successes and challenges in varicella vaccine. Ther Adv Vaccines. 2014;2:39–55. doi:10.1177/2051013613515621.
   PubMedGoogle Scholar
• Freer G, Pistello M. Varicella-zoster virus infection: natural history, clinical manifestations, immunity and current and future vaccination strategies. New Microbiol. 2018;41:95–105.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Varicella and herpes zoster vaccines: WHO position paper, June 2014. Wkly Epidemiol Rec. 2014;89:265–88.
   PubMedGoogle Scholar
• Federal Service for Supervision of Consumer Rights Protection and Human Welfare. On the state of sanitary and epidemiological well-being of the population in the Russian Federation in 2019: State report. Moscow (Russia); 2020.
   Google Scholar
• Mészner Z, Wysocki J, Richter D, Zavadska D, Ivaskeviciene I, Usonis V, Pokorn M, Mangarov A, Jancoriene L, Man SC, et al. Burden of varicella in Central and Eastern Europe: findings from a systematic literature review. Expert Rev Vaccines. 2019;18(3):281–93. doi:10.1080/14760584.2019.1573145.
   Web of Science ®Google Scholar
• Meyer PA, Seward JF, Jumaan AO, Wharton M. Varicella mortality: trends before vaccine licensure in the United States, 1970–1994. J Infect Dis. 2000;182:383–90. doi:10.1086/315714.
   PubMed Web of Science ®Google Scholar
• Jaeggi A, Zurbruegg RP, Aebi C. Complications of varicella in a defined central European population. Arch Dis Child. 1998;79:472–77. doi:10.1136/adc.79.6.472.
   PubMed Web of Science ®Google Scholar
• Bevilacqua S, Poircuitte JM, Boyer L, May T, Lascombes P, Venard V. Varicella arthritis in childhood: a case report and review of the literature. Pediatr Infect Dis J. 2011;30:980–82. doi:10.1097/INF.0b013e318223c0d8.
   PubMed Web of Science ®Google Scholar
• Majumdar A, Atam V, Mishra M. Rare case of post-varicella membranoproliferative glomerulonephritis presenting with massive proteinuria. BMJ Case Rep. 2020;13(3):e233084. doi:10.1136/bcr-2019-233084.
   Google Scholar
• Azak E, Cetin II. Acute myocarditis following varicella zoster infection in an immunocompetent adolescent: an uncommon complication. Arch Argent Pediatr. 2020;118:e284–e7.
   PubMed Web of Science ®Google Scholar
• Amlie-Lefond C, Gilden D. Varicella zoster virus: a common cause of stroke in children and adults. J Stroke Cerebrovasc Dis. 2016;25:1561–69. doi:10.1016/j.jstrokecerebrovasdis.2016.03.052.
   PubMed Web of Science ®Google Scholar
• Donahue JG, Kieke BA, Yih WK, Berger NR, McCauley JS, Baggs J, Zangwill KM, Baxter R, Eriksen EM, Glanz JM, et al. Varicella vaccination and ischemic stroke in children: is there an association? Pediatrics. 2009;123(2):e228–e34. doi:10.1542/peds.2008-2384.
   Web of Science ®Google Scholar
• Wysocki J, Malecka I, Stryczynska-Kazubska J, Rampakakis E, Kuter B, Wolfson LJ. Varicella in Poland: economic burden in children 1-12 years of age in Poland, 2010-2015. BMC Public Health. 2018;18:410. doi:10.1186/s12889-018-5298-8.
   PubMed Web of Science ®Google Scholar
• Meszner Z, Molnar Z, Rampakakis E, Yang HK, Kuter BJ, Wolfson LJ. Economic burden of varicella in children 1-12 Years of age in Hungary, 2011-2015. BMC Infect Dis. 2017;17:495. doi:10.1186/s12879-017-2575-6.
   PubMed Web of Science ®Google Scholar
• Baryshev MA, Chernyavskaya OP, Saltykova TS. Experience of the varicella vaccine introduction into regional vaccine schedule of the Russian Federation. Epidemiol Vaccin Protect. 2019;18:67–74. doi:10.31631/2073-3046-2019-18-6-67-74.
   Google Scholar
• 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.
   Web of Science ®Google Scholar
• Seward JF, Marin M, Vázquez M. Varicella vaccine effectiveness in the US vaccination program: a review. J Infect Dis. 2008;197(Suppl 2):S82–9. doi:10.1086/522145.
   PubMed Web of Science ®Google Scholar
• Marin M, Marti M, Kambhampati A, Jeram SM, Seward JF. Global varicella vaccine effectiveness: a meta-analysis. Pediatrics. 2016;137:e20153741. doi:10.1542/peds.2015-3741.
   PubMed Web of Science ®Google Scholar
• 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.
   Web of Science ®Google Scholar
• Sadaoka T, Depledge DP, Rajbhandari L, Venkatesan A, Breuer J, Cohen JI. In vitro system using human neurons demonstrates that varicella-zoster vaccine virus is impaired for reactivation, but not latency. Proc Natl Acad Sci USA. 2016;113:E2403–12. doi:10.1073/pnas.1522575113.
   PubMed Web of Science ®Google Scholar
• Zhou F, Ortega-Sanchez IR, Guris D, Shefer A, Lieu T, Seward JF. An economic analysis of the universal varicella vaccination program in the United States. J Infect Dis. 2008;197:S156–S64. doi:10.1086/522135.
   PubMed Web of Science ®Google Scholar
• Varela FH, Pinto LA, Scotta MC. Global impact of varicella vaccination programs. Hum Vaccin Immunother. 2019;15:645–57. doi:10.1080/21645515.2018.1546525.
   PubMed Web of Science ®Google Scholar
• Ministry of Health of the Russian Federation. State Register of Medicines; 2021.
   Google Scholar
• Hammond O, Wang Y, Green T, Antonello J, Kuhn R, Motley C, Stump P, Rich B, Chirmule N, Marchese RD. The optimization and validation of the glycoprotein ELISA assay for quantitative varicella-zoster virus (VZV) antibody detection. J Med Virol. 2006;78(12):1679–87. doi:10.1002/jmv.20754.
   Web of Science ®Google Scholar
• Ngai AL, Staehle BO, Kuter BJ, Cyanovich NM, Cho I, Matthews H, Keller P, Arvin AM, Watson B, White CJ. Safety and immunogenicity of one vs. two injections of Oka/Merck varicella vaccine in healthy children. Pediatr Infect Dis J. 1996;15(1):49–54. doi:10.1097/00006454-199601000-00011.
   Web of Science ®Google Scholar
• Silber JL, Chan IS, Wang WW, Matthews H, Kuter BJ. Immunogenicity of Oka/Merck varicella vaccine in children vaccinated at 12-14 months of age versus 15-23 months of age. Pediatr Infect Dis J. 2007;26:572–76. doi:10.1097/INF.0b013e318060d33d.
   PubMed Web of Science ®Google Scholar
• Chaves SS, Haber P, Walton K, Wise RP, Izurieta HS, Schmid DS, Seward J. Safety of varicella vaccine after licensure in the United States: experience from reports to the vaccine adverse event reporting system, 1995-2005. J Infect Dis. 2008;197(Suppl 2):S170–7. doi:10.1086/522161.
   PubMed Web of Science ®Google Scholar
• Baxter R, Ray P, Tran TN, Black S, Shinefield HR, Coplan PM, Lewis E, Fireman B, Saddier P. Long-term effectiveness of varicella vaccine: a 14-Year, prospective cohort study. Pediatrics. 2013;131(5):e1389–96. doi:10.1542/peds.2012-3303.
   Web of Science ®Google Scholar
• Bonanni P, Breuer J, Gershon A, Gershon M, Hryniewicz W, Papaevangelou V, Rentier B, Rümke H, Sadzot-Delvaux C, Senterre J, et al. Varicella vaccination in Europe - taking the practical approach. BMC Med. 2009;7:26. doi:10.1186/1741-7015-7-26.
   PubMed Web of Science ®Google Scholar