• Tino F Schwarz, Naresh Aggarwal, Beate Moeckesch, Isabelle Schenkenberger, Carine Claeys, Martine Douha, Olivier Godeaux, Katrijn Grupping, Thomas C Heineman, Marta Lopez Fauqued, Lidia Oostvogels, Peter Van den Steen, and Himal Lal.
• Central Laboratory and Vaccination Centre, Klinikum Würzburg Mitte, Standort Juliusspital, Würzburg.
• J. Infect. Dis. 2017 Dec 12; 216 (11): 1352-1361.

BackgroundThe 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.MethodsSubjects 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.ResultsA 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.ConclusionsNo interference in the immune responses to either vaccine was observed when the vaccines were coadministered, and no safety concerns were identified.Clinical Trials RegistrationNCT01954251.© The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

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