1343. Persistence of Immune Response to an Adjuvanted Varicella‐Zoster Virus Subunit Candidate Vaccine for up to Year 9 in Older Adults
Session: Poster Abstract Session: Herpes Zoster Vaccine
Friday, October 6, 2017
Room: Poster Hall CD
Posters
  • IDW_pos_1343_web.pdf (1.0 MB)
  • Background: In the ZOE-50 and ZOE-70 clinical trials, the candidate herpes-zoster subunit vaccine (HZ/su; 50µg varicella-zoster virus glycoprotein E [gE] and AS01B Adjuvant System) demonstrated high efficacy against HZ, with limited waning over 4 years and consistent efficacy across age cohorts. In adults ≥60 years of age, the immune responses elicited by 2 HZ/su doses administered 2 months apart persisted for at least 6 years.1 Here we report immunogenicity and safety 9 years post-initial vaccination.

    Methods: This Phase IIIB, open, long-term extension study (NCT02735915) followed 70 participants who received 2 HZ/su doses in the initial trial (NCT00434577). Blood samples to evaluate the persistence of cellular (intracellular cytokine staining) and humoral (ELISA) immune responses were taken at 9 years post-initial vaccination. Limited safety follow-up was performed (1 visit).

    Results: All 70 participants (mean age at dose 1: 72.3 years; 61.4% female) were included in the according-to-protocol analysis. The fold increases over pre-vaccination in the frequency of gE-specific CD4+ T-cells expressing ≥2 activation markers plateaued after 4 years post-dose 1 (year 4: 3.4, year 5: 3.0, year 6: 3.4, year 9: 3.4). Anti-gE antibody geometric mean concentrations were also stable from year 4 onwards (Table 1) and remained above the pre-vaccination value of 1213.1mIU/ml. Cellular and humoral responses at year 9 were similar across age strata (60-69, ≥70 years). No vaccine-related serious adverse events nor suspected HZ episodes were reported.

    Conclusion: In adults ≥60 years of age, HZ/su-induced cellular and humoral immune responses remained above pre-vaccination levels for at least 9 years post-initial vaccination, confirming immune persistence predictions2 based on 6-year data.

    Table 1

    Pre-vaccination

    (95% CI)

    Year 4

    (95% CI)

    Year 5

    (95% CI)

    Year 6

    (95% CI)

    Year 9

    (95% CI)

    Anti-gE antibody GMC (mlU/ml)

    1213.1

    (983.8-1495.9)

    9643.5

    (8309.7-11191.3)

    9124.1

    (7805.1-10666.0)

    8490.5

    (7292.1-9885.7)

    8931.2

    (7625.7-10460.3)

    Karlis Pauksens, MD1, Stephanie Volpe, MPH2, Tino F. Schwarz, MD3, Jan Smetana, MD Ph.D.4, Nicole Toursarkissian, MD5, Lars Rombo, MD6, Stéphanie Ravault, PhD7, Marie-Pierre David, MSc7, Adriana Bastidas, PhD2 and Lidia Oostvogels, MD2, (1)Uppsala University Hospital, Uppsala, Sweden, (2)GSK, Wavre, Belgium, (3)Central Laboratory and Vaccination Center, Stiftung Juliusspital, Wuerzburg, Germany, (4)Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic, (5)Practice Dr. Toursarkissian, Berlin, Germany, (6)Karolinska University Hospital, Stockholm, Sweden, (7)GSK, Rixensart, Belgium

    Disclosures:

    K. Pauksens, None

    S. Volpe, GSK: Employee , Salary

    T. F. Schwarz, GSK: Investigator and Scientific Advisor , Consulting fee

    J. Smetana, GSK: Investigator , personal fees

    N. Toursarkissian, None

    L. Rombo, None

    S. Ravault, GSK: Employee , GSK shares and Salary

    M. P. David, GSK: Employee , Salary and stock

    A. Bastidas, GSK: Employee , Salary

    L. Oostvogels, GSK: Employee and Shareholder , Salary and shares

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 4th with the exception of research findings presented at the IDWeek press conferences.