BACKGROUND: In adults aged ≥60 years, two doses of the herpes zoster subunit vaccine (HZ/su; 50 µg varicella-zoster virus glycoprotein E [gE] and AS01B Adjuvant System) elicited humoral and cell-mediated immune responses persisting for at least six years. We assessed immunogenicity nine years post-initial vaccination. METHODS: This open extension study (NCT02735915) followed 70 participants who received two HZ/su doses in the initial trial (NCT00434577). Blood samples to assess the cellular (intracellular cytokine staining) and humoral (ELISA) immunity were taken at year nine post-initial vaccination. RESULTS: Participants' mean age at dose 1 was 72.3 years. The fold increases over pre-vaccination in the mean frequency of gE-specific CD4+ T-cells expressing ≥2 activation markers plateaued from year four post-dose 1 until year nine. Anti-gE antibody geometric mean concentrations plateaued and remained above pre-vaccination levels from year four onwards. Immunogenicity at year nine was similar across age strata (60-69, ≥70 years) and confirmed statistical prediction model results using data for up to year six. Further modeling using all data up to year nine predicted immune responses would remain above the pre-vaccination level up to year 15. CONCLUSION: In adults aged ≥60 years, HZ/su-induced immunogenicity remained above pre-vaccination levels for at least nine years post-initial vaccination. SUMMARY: After vaccination with HZ/su, both cell mediated and humoral immunity remained above pre-vaccination levels up to year 9 regardless of age group. Immune responses are predicted to remain above baseline up to 15 years post initial vaccination.

b Clinical R and D GSK Wavre Belgium

c Biostatistics and Statistical Programming Clinical Evidence Generation R and D GSK Wavre Belgium

Department of Epidemiology Faculty of Military Health Sciences University of Defense Hradec Kralove Czech Republic

e Biostatistics and Statistical Programming Clinical Evidence Generation R and D GSK Rixensart Belgium

f Department of Infectious Disease Control Municipal Public Health Service Rotterdam Rijnmond Rotterdam The Netherlands

g Clinical R and D Pfizer Inc Collegeville PA USA

h Medical Sciences Section of Infectious Diseases Uppsala University Hospital Uppsala Sweden

i Clinical Laboratory Sciences GSK Rixensart Belgium

j Department of Medical Biochemistry and Microbiology Zoonosis Science Center Uppsala University Uppsala Sweden

k Department of Infectious Diseases Public Health Service of Amsterdam Amsterdam The Netherlands

l Clinical Development Genocea Biosciences Cambridge MA USA

Laboratory Medicine and Vaccination Klinikum Würzburg Mitte Standort Juliusspital Würzburg Germany

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Immunogenicity of the Adjuvanted Recombinant Zoster Vaccine: Persistence and Anamnestic Response to Additional Doses Administered 10 Years After Primary Vaccination

Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older

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ClinicalTrials.gov
NCT02735915, NCT00434577