753. Immunogenicity and Safety of 2 Doses of an Investigational Herpes Zoster Subunit Vaccine Administered 2, 6 or 12 Months Apart in Adults 50 Years and Older: Results of a Phase III, Randomized, Open-label, Multicenter Trial
Session: Poster Abstract Session: Vaccines: New and Novel
Thursday, October 27, 2016
Room: Poster Hall
Posters
  • GSK-IDWEEK 2016-poster 753.pdf (317.0 kB)
  • Background: Two doses of a candidate herpes zoster (HZ) subunit vaccine (HZ/su; 50 µg varicella-zoster virus glycoprotein E [gE] and AS01B Adjuvant System) administered 2 months (mo) apart in adults ≥50 years of age demonstrated >90% efficacy in preventing HZ and had a clinically acceptable safety profile. Here we report immunogenicity and safety of 2 HZ/su doses administered at intervals longer than 2 mo.

    Methods: In this phase III, open-label trial (NCT01751165) conducted in the United States and Estonia, 354 adults ≥50 years of age were randomized 1:1:1 to receive 2 doses of HZ/su at 0,2 mo, 0,6 mo, or 0,12 mo. Blood samples for anti-gE ELISA were collected at pre-vaccination and at 1 and 12 mo post-dose 2. Primary objective: to compare immune responses to HZ/su 1 mo post-dose 2, when given on 0,6 mo and 0,12 mo schedules to those following 0,2 mo administration. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days post-each dose, respectively. Serious AEs (SAEs) and potential immune-mediated diseases (pIMDs) were recorded from dose 1 to 12 mo post-dose 2.

    Results: 346 subjects completed the study and 343 were included in the according-to-protocol cohort for immunogenicity. The mean age at dose 1 was 64.5 (0,2 mo), 64.0 (0,6 mo) and 64.1 (0,12 mo) years. One mo post-dose 2, vaccine response rates were similar following the 0,6 mo and 0,12 mo schedules and the pre-defined criterion was met (Figure 1). Consecutively, non-inferiority compared to the immune responses of HZ/su given at 0,2 mo was assessed, but demonstrated only for the 0,6 mo schedule (Figure 2). HZ/su elicited robust anti-gE immune responses, which remained at least 11.6-fold the pre-vaccination levels at 12 mo post-dose 2 (Figure 1). Pain was the most commonly reported solicited AE (Figure 3). 26 subjects reported at least one SAE (0,2 mo n=5, of which 1 fatal; 0,6 mo n=9, none fatal; 0,12 mo n=12, 1 fatal); none assessed as related to the vaccination. No pIMDs were reported.

    Conclusion: Non-inferiority of the 0,6 mo schedule (but not of the 0,12 mo) compared to the 0,2 mo schedule was demonstrated. With an acceptable safety profile, HZ/su elicited robust anti-gE immune responses that persisted for up to at least 12 mo post-dose 2, irrespective of schedule.

    Funding: GlaxoSmithKline Biologicals SA

     

     

     

    Airi Poder, MD1, Brecht Geeraerts, PhD2, Himal Lal, MD3, Lidia Oostvogels, MD2, Carline Vanden Abeele, MSc2 and Thomas C. Heineman, MD, PhD3, (1)Tartu University Hospital, Tartu, Estonia, (2)GSK Vaccines, Wavre, Belgium, (3)GSK Vaccines, King of Prussia, PA

    Disclosures:

    A. Poder, None

    B. Geeraerts, GSK group of companies: Employee , Salary and shares

    H. Lal, GSK group of companies: Employee , Salary and stock grants

    L. Oostvogels, GSK group of companies: owner of stock options , Salary

    C. Vanden Abeele, GSK group of companies: Employee , Salary

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

    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.