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

• Published in: The Journal of infectious diseases Vol. 216; no. 11; pp. 1352 - 1361
• Main Authors: Schwarz, Tino F., Aggarwal, Naresh, Moeckesch, Beate, Schenkenberger, Isabelle, Claeys, Carine, Douha, Martine, Godeaux, Olivier, Grupping, Katrijn, Heineman, Thomas C., Fauqued, Marta Lopez, Oostvogels, Lidia, Van den Steen, Peter, Lal, Himal
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 12.12.2017
• Subjects: Adjuvants, Immunologic - administration & dosage; Adjuvants, Immunologic - adverse effects; Adjuvants, Immunologic - pharmacology; Adjuvants, Pharmaceutic - administration & dosage; Adjuvants, Pharmaceutic - pharmacology; Aged; Antibodies, Viral - blood; Antibodies, Viral - immunology; Antibody Formation - immunology; Drug Combinations; Drug-Related Side Effects and Adverse Reactions - epidemiology; Editor's Choice; Female; Herpes Zoster - immunology; Herpes Zoster - prevention & control; Herpes Zoster Vaccine - adverse effects; Herpes Zoster Vaccine - immunology; Herpesvirus 3, Human - immunology; Humans; Immunity, Cellular; Immunity, Humoral; Immunogenicity, Vaccine - immunology; Influenza Vaccines - administration & dosage; Influenza Vaccines - immunology; Influenza, Human - drug therapy; Major and Brief Reports; Male; Middle Aged; Seasons; Vaccination - methods; Vaccines, Inactivated; Vaccines, Subunit - administration & dosage; Vaccines, Subunit - adverse effects; Vaccines, Subunit - immunology; VIRUSES; influenza; herpes zoster; subunit vaccine; adjuvant; coadministration
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1093/infdis/jix481

When the adjuvanted HZ subunit vaccine candidate was coadministered with a quadrivalent seasonal influenza vaccine, no interference in the immune responses were observed, and no safety concerns were identified. Abstract Background 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. 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. Safety information was collected throughout the duration of the study. Results 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. Conclusions No interference in the immune responses to either vaccine was observed when the vaccines were coadministered, and no safety concerns were identified. Clinical Trials Registration NCT01954251.