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

Erin M Paradis, Oleg Tikhonov, Xin Cao, Susanna M Kharit, Aleksandr Fokin, Heather L Platt, Frederick Wittke, Veronika Jotterand, Erin M Paradis, Oleg Tikhonov, Xin Cao, Susanna M Kharit, Aleksandr Fokin, Heather L Platt, Frederick Wittke, Veronika Jotterand

Abstract

Varicella (chickenpox) is a common, highly contagious disease caused by primary infection with varicella zoster virus (VZV), which can result in bacterial superinfection, central nervous system complications, and hospitalization. Stage 2 of this Phase 3 open-label study (ClinicalTrials.gov identifier: NCT03843632) enrolled 100 healthy infants, children, and adolescents (12 months-6 years, n = 37; 7-12 years, n = 33; 13-17 years, n = 30) without a clinical history of varicella. Participants aged 12 months-12 years were administered 1 dose of VARIVAX™ 0.5 mL (Varicella Virus Vaccine Live [Oka/Merck]) and adolescents aged 13-17 years were administered 2 doses 6 weeks apart. For participants seronegative at baseline (VZV antibody titer <1.25 glycoprotein enzyme-linked immunosorbent assay [gpELISA] units/mL), immunogenicity was assessed by seroconversion (VZV antibody titer ≥5 gpELISA units/mL) and VZV antibody geometric mean titers 6 weeks after the final dose. For participants who were VZV seropositive at baseline (VZV antibody titer ≥1.25 gpELISA units/mL), immunogenicity was assessed by antibody titer geometric mean fold rise and percentage of participants with ≥4-fold rise in antibody titer 6 weeks after the final dose. A Vaccine Report Card was used to report solicited and unsolicited adverse events through 42 days post-vaccination. After series completion among seronegative participants across age groups (n = 74), 98.6% demonstrated seroconversion 6 weeks post-vaccination; among seropositive participants (n = 26), 65.4% had ≥4-fold rise in antibody titer 6 weeks post-vaccination. No new safety signals were observed. Administering VARIVAX to infants, children, and adolescents resulted in an acceptable immune response with a safety profile consistent with the licensed product.

Keywords: Phase 3; Russia; VARIVAX™; Varicella vaccine; adolescents; chickenpox; children; immunogenicity; pediatric; safety.

Conflict of interest statement

EP, XC, and HLP are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD). OT and AF are employees of MSD, Russia. FW and VJ are employees of MSD, Switzerland.

Figures

Figure 1.
Figure 1.
Changes in geometric mean titer from baseline following administration of varicella vaccine in (A) adolescents 13–17 years post-Dose 2, (B) children aged 7–12 years post-Dose 1 and (C) children aged 12 months–6 years post-Dose 1.CI, confidence interval; gpELISA, glycoprotein enzyme-linked immunosorbent assay.

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