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
T. F. Schwarz,
GSK group of companies:
honoraria for conducting clinical trials
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