BACKGROUND: The herpes zoster subunit vaccine (HZ/su), consisting of varicella-zoster virus glycoprotein E (gE) and AS01B Adjuvant System, was highly efficacious in preventing herpes zoster in the ZOE-50 and ZOE-70 trials. We present immunogenicity results from those trials. METHODS: Participants (ZOE-50: ≥50; ZOE-70: ≥70 years of age) received 2 doses of HZ/su or placebo, 2 months apart. Serum anti-gE antibodies and CD4 T cells expressing ≥2 of 4 activation markers assessed (CD42+) after stimulation with gE-peptides were measured in subcohorts for humoral (n = 3293) and cell-mediated (n = 466) immunogenicity. RESULTS: After vaccination, 97.8% of HZ/su and 2.0% of placebo recipients showed a humoral response. Geometric mean anti-gE antibody concentrations increased 39.1-fold and 8.3-fold over baseline in HZ/su recipients at 1 and 36 months post-dose 2, respectively. A gE-specific CD42+ T-cell response was shown in 93.3% of HZ/su and 0% of placebo recipients. Median CD42+ T-cell frequencies increased 24.6-fold (1 month) and 7.9-fold (36 months) over baseline in HZ/su recipients and remained ≥5.6-fold above baseline in all age groups at 36 months. The proportion of CD4 T cells expressing all 4 activation markers increased over time in all age groups. CONCLUSIONS: Most HZ/su recipients developed robust immune responses persisting for 3 years following vaccination. CLINICAL TRIALS REGISTRATION: NCT01165177; NCT01165229.

Central Laboratory and Vaccination Centre Klinikum Würzburg Mitte Standort Juliusspital Germany

Department of Family Medicine Taipei Veterans General Hospital and National Yang Ming University School of Medicine Taiwan

Department of Infectious Diseases Uppsala University Hospital Sweden

Department of Medicine University of Colorado Anschutz Medical Campus Aurora

Department of Pediatrics University of Colorado Anschutz Medical Campus Aurora

Diagnostics Research Group San Antonio Texas

Division of Infectious Disease Department of Internal Medicine Korea University College of Medicine Seoul

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

Federal University of Sao Paulo Brazil

GSK King of Prussia Pennsylvania

GSK Rixensart Belgium

GSK Rockville Maryland

GSK Wavre Belgium

Health Sciences North Research Institute Sudbury Ontario Canada

Institute of Tropical Medicine University Clinic of Tuebingen Germany

Japan Physicians Association Kanda Chiyoda ku Tokyo

The Westmead Institute for Medical Research University of Sydney Australia

Vaccine Research Center University of Tampere Finland

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ClinicalTrials.gov
NCT01165177, NCT01165229