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.
Bibliographical noteFunding Information:
Potential conflicts of interest. M. K. C., S. R., B. S., C. V. A., P. V. dS., and I. V. are employees, and T. C. H., H. L., and O. G. are former employees, of the GSK group of companies. T. C. H., H. L., O. G., M. K. C., B. S., and P. V. dS. hold shares or stock options from GSK as part of their current or former employee remuneration. A. L. C. received honoraria paid to his institution from GSK, Merck Sharp & Dohme (Merck), and BioCSL/Sequirus outside the submitted work. T. C. H. is a consultant for GSK and is the coinventor of a patent application related to the vaccine used in this study. H. L. is a current employee of Pfizer and receives stock options as part of his employee remuneration. R. C. reports receiving lecture fees from Pfizer outside the submitted work. J. E. M. received honoraria and fees paid to her institution from GSK, Sanofi Pasteur, Merck, and Pfizer, as well as travel support from Sanofi Pasteur, Merck, and Pfizer outside the submitted work. T. V., W. S. C., and M. E. received fees paid to their institutions from GSK to perform the study. T. V. received lecture fees from GSK outside the submitted work. W. S. C. received grant support from Merck and AbbVie Korea outside the submitted work, and lecture fees from GSK, Pfizer, Merck, SK Chemicals, and Green Cross. M. E. received grants from the Federal Ministry of Education and Research, German Research Foundation, and Baxter outside the submitted work. H. I. received grants and personal fees from GSK and grants from Japan Vaccine during the conduct of the study, as well as grants and personal fees from Daiichi-Sankyo and grants from Sanofi Pasteur and personal fees from Shionogi outside the submitted work. T. F. S. received personal fees from GSK, Pfizer, and Sanofi Pasteur outside the submitted work. J. S. received personal fees from GSK and Pfizer outside the submitted work. L. Y. W. received grant from GSK during the conduct of the study. M. J. L. received fees for serving on advisory boards from Merck and GSK, grant support from Merck and GSK, and royalties from a patent related to a zoster vaccine held with Merck. S. J. H., C. A., and K. P. declare no conflict of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
Financial support. This work was supported by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was involved in all stages of the conduct and analysis of the studies. GlaxoSmithKline Biologicals SA covered the costs associated with the development and the publishing of the present manuscript.
© The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved.
- Adjuvant system
- GE subunit vaccine
- Herpes zoster vaccine
- Varicella-zoster virus
ASJC Scopus subject areas