TY - JOUR

T1 - 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

AU - Ardentova, Nadezhda

AU - Deev, Ivan

AU - Denisov, Mikhail

AU - Galytskaya, Marina

AU - Gayvoronskaya, Anna

AU - Ilina, Natalia Ivanovna

AU - Karnaukhov, Vitaly

AU - Karpova, Galina

AU - Lutsevich, Konstantin

AU - Romanova, Tatiana

AU - Rybina, Olga Victorovna

AU - Sabitov, Alebai

AU - Tsarkova, Sophia Anatolyevna

AU - Zakharzhevskaya, Tatiana

AU - Namazova-Baranova, Leyla

AU - Habib, Md Ahsan

AU - Povey, Michael

AU - Efendieva, Kamilla

AU - Fedorova, Olga

AU - Fedoseenko, Marina

AU - Ivleva, Tatyana

AU - Kovshirina, Yulia

AU - Levina, Julia

AU - Lyamin, Artem

AU - Ogorodova, Ludmila

AU - Reshetko, Olga

AU - Romanenko, Viktor

AU - Ryzhenkova, Inna

AU - Sidorenko, Irina

AU - Yakovlev, Yakov

AU - Zhestkov, Aleksandr

AU - Tatochenko, Vladimir

AU - Scherbakov, Michael

AU - Shpeer, Evgeniy L.

AU - Casabona, Giacomo

N1 - Funding Information: This work was funded by GlaxoSmithKline Biologicals SA, including all costs associated with the development and publishing of this manuscript. The authors acknowledge Dr Nadezhda Snegova and Dr Vitaliy Fomin, who passed away, for their contribution during the conduct of the study. Authors thank Ekaterina Safonova for her involvement in Russia throughout the conduct of the global study. Authors also thank the Modis platform for editorial assistance and manuscript coordination, on behalf of GSK. Lotte Math' and Urszula Miecielica provided medical writing support and Julie Mellery coordinated the manuscript development and editorial support. Publisher Copyright: © 2021 GlaxoSmithKline Biologicals S.A. Published with license by Taylor & Francis Group, LLC.

PY - 2022/1/31

Y1 - 2022/1/31

N2 - In Russia, a universal varicella vaccination (UVV) program has not been implemented, and varicella vaccination coverage is low. We assessed the efficacy, antibody persistence, and safety of one- and two-dose varicella vaccination schedules in Russian children with a ten-year follow-up period, as part of an international phase IIIB, observer-blind, randomized, controlled trial (NCT00226499). Children aged 12–22 months were randomized (3:3:1) to receive two doses of tetravalent measles-mumps-rubella-varicella vaccine (V2 group), one dose trivalent measles-mumps-rubella (MMR) vaccine and one dose of varicella vaccine (V1 group), or two doses of MMR vaccine (V0 [control] group), 42 days apart. Main study outcomes were: vaccine efficacy (VE) against confirmed varicella cases, anti-varicella zoster virus (VZV) seropositivity rates and geometric mean concentrations, and reporting of (serious) adverse events ([S]AEs). The total vaccinated cohort in Russia comprised 1000 children; 900 were followed up until study end (year [Y] 10). VE estimates against confirmed varicella (Y10) were 92.4% in the V2 group and 74.7% in the V1 group. Anti-VZV seropositivity rates remained ≥99.4% in the V2 group and ≥89.7% in the V1 group from day 42 post-vaccination 2 until Y10. Occurrence of (un)solicited AEs and SAEs was similar across groups and confirmed the safety profile of the vaccines. No vaccination-related SAEs or deaths were reported. These results are consistent with the global trial results, i.e., the highest VE estimates observed following the two-dose schedule compared to the one-dose schedule. These data may inform decision-making related to potential implementation of a UVV program.

AB - In Russia, a universal varicella vaccination (UVV) program has not been implemented, and varicella vaccination coverage is low. We assessed the efficacy, antibody persistence, and safety of one- and two-dose varicella vaccination schedules in Russian children with a ten-year follow-up period, as part of an international phase IIIB, observer-blind, randomized, controlled trial (NCT00226499). Children aged 12–22 months were randomized (3:3:1) to receive two doses of tetravalent measles-mumps-rubella-varicella vaccine (V2 group), one dose trivalent measles-mumps-rubella (MMR) vaccine and one dose of varicella vaccine (V1 group), or two doses of MMR vaccine (V0 [control] group), 42 days apart. Main study outcomes were: vaccine efficacy (VE) against confirmed varicella cases, anti-varicella zoster virus (VZV) seropositivity rates and geometric mean concentrations, and reporting of (serious) adverse events ([S]AEs). The total vaccinated cohort in Russia comprised 1000 children; 900 were followed up until study end (year [Y] 10). VE estimates against confirmed varicella (Y10) were 92.4% in the V2 group and 74.7% in the V1 group. Anti-VZV seropositivity rates remained ≥99.4% in the V2 group and ≥89.7% in the V1 group from day 42 post-vaccination 2 until Y10. Occurrence of (un)solicited AEs and SAEs was similar across groups and confirmed the safety profile of the vaccines. No vaccination-related SAEs or deaths were reported. These results are consistent with the global trial results, i.e., the highest VE estimates observed following the two-dose schedule compared to the one-dose schedule. These data may inform decision-making related to potential implementation of a UVV program.

KW - Antibody persistence

KW - children

KW - combined vaccination

KW - long-term efficacy

KW - Russia

KW - varicella

KW - Vaccination/adverse effects

KW - Follow-Up Studies

KW - Vaccines, Attenuated/adverse effects

KW - Herpes Zoster Vaccine/administration & dosage

KW - Humans

KW - Infant

KW - Immunization Schedule

KW - Child

UR - http://www.scopus.com/inward/record.url?scp=85113627026&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/record.url?scp=85129780011&partnerID=8YFLogxK

UR - https://www.mendeley.com/catalogue/1a5d487b-2af5-3d30-ab4d-1b61daa0bfab/

U2 - 10.1080/21645515.2021.1959148

DO - 10.1080/21645515.2021.1959148

M3 - Article

C2 - 34435933

AN - SCOPUS:85113627026

VL - 18

JO - Human Vaccines and Immunotherapeutics

JF - Human Vaccines and Immunotherapeutics

SN - 2164-5515

IS - 1

M1 - 1959148

ER -