Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine Coadministered With Seasonal Influenza Vaccine in Adults Aged 50 Years or Older.

Tino F Schwarz,Carine Claeys,Beate Moeckesch,Katrijn Grupping,Martine Douha,Lidia Oostvogels,Peter Van Den Steen,Olivier Godeaux,Thomas C Heineman,Naresh Aggarwal,Isabelle Schenkenberger,Himal Lal,Marta Lopez Fauqued

doi:10.1093/infdis/jix481

Abstract

The immunogenicity and safety of an adjuvanted herpes zoster subunit (HZ/su) vaccine when coadministered with a quadrivalent seasonal inactivated influenza vaccine (IIV4) was investigated in a phase 3, open-label, randomized clinical trial in adults aged ≥50 years. Subjects were randomized 1:1 to receive either HZ/su (varicella zoster virus glycoprotein E; AS01B Adjuvant System) and IIV4 at day 0 followed by a second HZ/su dose at month 2 (coadministration group), or IIV4 at month 0 and HZ/su at months 2 and 4 (control group). The primary objectives were the HZ/su vaccine response rate in the coadministration group and the noninferiority of the antibody responses to HZ/su and IIV4 in the coadministration compared with the control group. Safety information was collected throughout the duration of the study. A total of 413 subjects were vaccinated in the coadministration group and 415 in the control group. The HZ/su vaccine response rate in the coadministration group was 95.8% (95% confidence interval, 93.3%-97.6%) and the anti-glycoprotein E GMCControl/Coadmin ratio was 1.08 (.97-1.20). The primary noninferiority objectives were met. No safety concerns were observed. No interference in the immune responses to either vaccine was observed when the vaccines were coadministered, and no safety concerns were identified. NCT01954251.

Highlights

The immunogenicity and safety of an adjuvanted herpes zoster subunit (HZ/su) vaccine when coadministered with a quadrivalent seasonal inactivated influenza vaccine (IIV4) was investigated in a phase 3, open-label, randomized clinical trial in adults aged ≥50 years
Reactivation of latent varicella-zoster virus (VZV) in sensory ganglia results in herpes zoster (HZ; shingles); typically a painful dermatomal rash that lasts for several weeks and can result in a neuropathic pain syndrome that can persist for months after the rash has resolved
Because older adults could benefit from receiving HZ/su and influenza vaccinations in a single clinic visit, we investigated the immunogenicity, safety, and reactogenicity of a coadministration schedule in which the first dose of HZ/su is given with a licensed quadrivalent seasonal Inactivated split-virion influenza vaccines (IIVs) (IIV4) in adults aged ≥50 years, compared with a sequential administration schedule

Summary

Methods

Subjects were randomized 1:1 to receive either HZ/su (varicella zoster virus glycoprotein E; AS01B Adjuvant System) and IIV4 at day 0 followed by a second HZ/su dose at month 2 (coadministration group), or IIV4 at month 0 and HZ/su at months 2 and 4 (control group). The primary objectives were the HZ/su vaccine response rate in the coadministration group and the noninferiority of the antibody responses to HZ/su and IIV4 in the coadministration compared with the control group. Secondary objectives were to assess the noninferiority of HI antibody seroconversion rates (SCRs) in the coadministration group for each IIV4 strain versus those in control group, to assess IIV4 immunogenicity for each strain in terms of GMT and in terms of the age group–specific (age 50–64 or ≥65 years) Center for Biologics Evaluation and Research (CBER) criteria for seroprotection rates (SPRs) and SCRs [17], and to evaluate the safety and reactogenicity of both vaccines when coadministered or sequentially administered

Results

Discussion

Conclusion