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Clinical Trial
. 2021 May 6;39(19):2643-2651.
doi: 10.1016/j.vaccine.2021.03.085. Epub 2021 Apr 12.

Ten-year follow-up on efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: Results from five East European countries

Roman Prymula  1 , Michael Povey  2 , Jerzy Brzostek  3 , Hana Cabrnochova  4 , Roman Chlibek  5 , Hanna Czajka  6 , Giedra Leviniene  7 , Sorin Man  8 , Mihai Neamtu  9 , Petr Pazdiora  10 , Doina Plesca  11 , Renata Ruzkova  12 , Maria Stefkovicova  13 , Vytautas Usonis  14 , Daniela Verdanova  15 , Jacek Wysocki  16 , Giacomo Casabona  17 , Md Ahsan Habib  18
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Free article
Clinical Trial

Ten-year follow-up on efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: Results from five East European countries

Roman Prymula et al. Vaccine. .
Free article

Abstract

Background: We assessed the 10-year efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV) or one dose of a monovalent varicella vaccine (V) in children from Czech Republic, Lithuania, Poland, Romania and Slovakia.

Methods: This was a phase IIIB follow-up of an observer-blind, randomized, controlled trial (NCT00226499). In phase A, healthy children aged 12-22 months from 10 European countries were randomized in a 3:3:1 ratio to receive two doses of MMRV (MMRV group), one dose of MMR followed by one dose of V (MMR + V group), or two doses of MMR (MMR; control group), 42 days apart. Vaccine efficacy (VE) against varicella (confirmed by viral DNA detection or epidemiological link and clinical assessment) was calculated with 95% confidence intervals using Cox proportional hazards regression model. Immunogenicity was assessed as seropositivity rates and geometric mean concentrations (GMCs). Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs) were recorded.

Results: A total of 3705 children were vaccinated (1590, MMRV group; 1586, MMR + V group; 529, MMR group). There were 663 confirmed varicella cases (47, MMRV group; 349, MMR + V group; 267, MMR group). VE ranged between 95.4% (Lithuania) and 97.4% (Slovakia) in the MMRV group and between 59.3% (Lithuania) and 74% (Slovakia) in the MMR + V group. At year 10, seropositivity rates were 99.5%-100% in the MMRV group, 98%-100% in the MMR + V group and 50%-100% in the MMR control group, and the anti-VZV antibody GMCs were comparable between MMRV and MMR + V groups. The occurrence of solicited and unsolicited AEs was similar across groups and no SAE was considered as vaccination-related. No new safety concerns were identified.

Conclusions: Our results indicated that two doses of varicella zoster virus-containing vaccine provided better protection than one dose against varicella and induced antibody responses that persisted 10 years post-vaccination.

Keywords: Children; Efficacy; Live-attenuated varicella vaccine; Long-term follow-up; Measles-mumps-rubella; Varicella zoster virus.

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Conflict of interest statement

Declaration of Competing Interest GC, MAH, MP are employees of the GSK group of companies, and GC and MAH hold shares in the GSK group of companies as part of the employee remuneration. DV, JW, MS, RP, VU have received grants from the GSK group of companies during the conduct of the study. JW, MS have received consulting and lecture fees from the GSK group of companies. MS has received non-financial support from the GSK group of companies to attend scientific meetings, outside the submitted work. DV reports to have received personal fees by Biovomed during the conduct of the study. DV moreover reports to have received personal fees from the GSK group of companies, MSD, Sanofi and Pfizer, outside the submitted work. RR reports that her institution received fees during the conduct of the study. DP, GL, HCa, HCz, JB, NM, PP, RC, SM have not received any consulting fees and declare that they have no conflicts of interest and have no non-financial interest to declare.

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