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

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
• Nader S, Bergen R, Sharp M, Arvin AM. Age-related differences in cell-mediated immunity to varicella-zoster virus among children and adults immunized with live attenuated varicella vaccine. J Infect Dis. 1995;171:13–17. doi:10.1093/infdis/171.1.13.
   PubMed Web of Science ®Google Scholar
• 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;1:15016. doi:10.1038/nrdp.2015.16.
   PubMed 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
• Enders G, Miller E, Cradock-Watson J, Bolley I, Ridehalgh M. Consequences of varicella and herpes zoster in pregnancy: prospective study of 1739 cases. Lancet. 1994;343:1548–51. doi:10.1016/S0140-6736(94)92943-2.
   PubMed Web of Science ®Google Scholar
• Hambleton S, Steinberg SP, Larussa PS, Shapiro ED, Gershon AA. Risk of herpes zoster in adults immunized with varicella vaccine. J Infect Dis. 2008;197(Suppl 2):S196–9. doi:10.1086/522131.
   PubMed Web of Science ®Google Scholar
• Riera-Montes M, Bollaerts K, Heininger U, Hens N, Gabutti G, Gil A, Nozad B, Mirinaviciute G, Flem E, Souverain A, et al. Estimation of the burden of varicella in Europe before the introduction of universal childhood immunization. BMC Infect Dis. 2017;17:353. doi:10.1186/s12879-017-2445-2.
   PubMed Web of Science ®Google 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.
   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
• 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;23:132–37. doi:10.1097/01.inf.0000109287.97518.67.
   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
• 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;78:1679–87. doi:10.1002/jmv.20754.
   PubMed Web of Science ®Google Scholar
• Kosuwon P, Sutra S, Kosalaraksa P. Advantage of a two-dose versus one-dose varicella vaccine in healthy non-immune teenagers and young adults. Southeast Asian J Trop Med Public Health. 2004;35:697–701.
   PubMedGoogle Scholar
• Plotkin SA, Plotkin SA. Correlates of vaccine-induced immunity. Clin Infect Dis. 2008;47:401–09. doi:10.1086/589862.
   PubMed 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
• Sperber SJ, Smith BV, Hayden FG. Serologic response and reactogenicity to booster immunization of healthy seropositive adults with live or inactivated varicella vaccine. Antiviral Res. 1992;17:213–22. doi:10.1016/0166-3542(92)90042-4.
   PubMed Web of Science ®Google Scholar
• Baxter R, Tran TN, Ray P, Lewis E, Fireman B, Black S, Shinefield HR, Coplan PM, Saddier P. Impact of vaccination on the epidemiology of varicella: 1995-2009. Pediatrics. 2014;134(1):24–30. doi:10.1542/peds.2013-4251.
   Web of Science ®Google Scholar
• Wutzler P, Bonanni P, Burgess M, Gershon A, Safadi MA, Casabona G. Varicella vaccination - the global experience. Expert Rev Vaccines. 2017;16:833–43. doi:10.1080/14760584.2017.1343669.
   PubMed Web of Science ®Google Scholar
• Woodward M, Marko A, Galea S, Eagel B, Straus W. Varicella virus vaccine live: a 22-year review of postmarketing safety data. Open Forum Infect Dis. 2019;6(8):ofz295. doi:10.1093/ofid/ofz295.
   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
• Macartney K, Heywood A, McIntyre P. Vaccines for post-exposure prophylaxis against varicella (chickenpox) in children and adults. Cochrane Database Syst Rev. 2014;2014:Cd001833.
   PubMedGoogle Scholar
• Centers for Disease Control and Prevention. Herpes zoster vaccination. 2015.
   Google Scholar