751. Randomized, Phase III Clinical Trial to Assess the Immunogenicity and Safety of an Investigational Subunit Adjuvanted Herpes Zoster Vaccine Co-Administered with a Seasonal Quadrivalent Inactivated Influenza Vaccine in Adults Aged 50 Years and Older
Session: Poster Abstract Session: Vaccines: New and Novel
Thursday, October 27, 2016
Room: Poster Hall
  • Poster 751 - Tino Schwarz.pdf (345.4 kB)
  • Background: The recombinant herpes zoster (HZ) subunit vaccine candidate (HZ/su) has demonstrated >90% efficacy in preventing HZ, robust immunogenicity and an acceptable safety profile in adults ≥50 years of age (YOA). Here we report immunogenicity and safety data of HZ/su and an influenza vaccine when co-administered.

    Methods: This phase III, randomized, open-label, multi-country trial (NCT01954251) enrolled adults ≥50 YOA during 2013 influenza vaccination season. Immunogenicity and safety of HZ/su (50 µg varicella-zoster virus glycoprotein E and AS01B Adjuvant System) and a co-administered licensed quadrivalent inactivated influenza vaccine (IIV4) containing two A and two B strains were assessed and compared to those of each vaccine administered separately.  Subjects received intramuscularly either (1) HZ/su and IIV4, co-administered (Day [D] 0) and HZ/su (Month [M] 2) (co-ad group), or (2) IIV4 (D0) and HZ/su (M2, M4) sequentially (control group). Humoral immune responses were assessed 21D after IIV4 administration and 1M after second HZ/su dose administration. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30D after each vaccination, respectively. Serious AEs (SAEs) and potential immune-mediated diseases (pIMDs) were collected for 12M after last dose.

    Results: 828 subjects were vaccinated (co-ad: 413; control: 415). The mean age in both groups was 63.4 years. Vaccine response rates for HZ/su were comparable in both groups. Humoral immune responses to HZ/su and IIV4 antigens were substantial and non-inferior when co-administered compared to separate dosing (Table 1). Solicited AEs were reported at similar rates in co-ad and control groups and were mostly mild or moderate (Table 2). The percentages of subjects reporting unsolicited AEs considered as vaccine-related by the investigator were comparable between co-ad and control groups. 8 subjects died (co-ad: 3; control: 5), 73 reported non-fatal SAEs (co-ad: 39; control: 34) and 6 experienced a pIMD (co-ad: 4; control: 2) throughout the study. No SAEs or pIMDs were considered vaccine-related.

    Conclusion: When co-administered, HZ/su and IIV4 were well tolerated. No immunologic interference was observed for either vaccine.

    Funding: GlaxoSmithKline Biologicals SA

    Tino F. Schwarz, PhD, MD1, Naresh Aggarwal, MBBS, FCFP2, Beate Moeckesch, MD3, Isabelle Schenkenberger, MD4, Carine Claeys, MD5, Olivier Godeaux, MD MPH6, Katrijn Grupping, PhD5, Thomas C. Heineman, MD, PhD7, Lidia Oostvogels, MD5, Peter Van Den Steen, PhD5 and Himal Lal, MD7, (1)Central Laboratory and Vaccination Center, Stiftung Juliusspital, Wuerzburg, Germany, (2)Aggarwal and Associates Limited, Brampton, ON, Canada, (3)Gemeinschaftspraxis, Weinheim, Germany, (4)Klinische Forschung Berlin, Berlin, Germany, (5)GSK Vaccines, Wavre, Belgium, (6)Jansen Infectious Diseases and Vaccines, Leiden, Netherlands, (7)GSK Vaccines, King of Prussia, PA


    T. F. Schwarz, GSK group of companies: Board Member , Investigator and Speaker's Bureau , honoraria for conducting clinical trials and Speaker honorarium

    N. Aggarwal, None

    B. Moeckesch, None

    I. Schenkenberger, None

    C. Claeys, GSK group of companies: Employee and Shareholder , Salary

    O. Godeaux, GSK group of companies: Ex GSK-employee and Shareholder , Salary

    K. Grupping, GSK group of companies: Employee , Salary

    T. C. Heineman, GSK group of companies: Employee and Shareholder , Salary and stock

    L. Oostvogels, GSK group of companies: Employee , Salary

    P. Van Den Steen, GSK group of companies: Employee , Salary

    H. Lal, GSK group of companies: Employee and Shareholder , Salary and Stock as compensation

    Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.