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J Infect Dis. 2018 May 5;217(11):1750-1760. doi: 10.1093/infdis/jiy095.

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

Author information

1
The Westmead Institute for Medical Research, University of Sydney, Australia.
2
GSK, King of Prussia, Pennsylvania.
3
GSK, Wavre, Belgium.
4
Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic.
5
Department of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taiwan.
6
Health Sciences North Research Institute, Sudbury, Ontario, Canada.
7
Vaccine Research Center, University of Tampere, Finland.
8
Diagnostics Research Group, San Antonio, Texas.
9
Division of Infectious Disease, Department of Internal Medicine, Korea University College of Medicine, Seoul.
10
Institute of Tropical Medicine, University Clinic of Tuebingen, Germany.
11
Japan Physicians Association, Kanda, Chiyoda-ku, Tokyo.
12
GSK, Rockville, Maryland.
13
Department of Infectious Diseases, Uppsala University Hospital, Sweden.
14
GSK, Rixensart, Belgium.
15
Central Laboratory and Vaccination Centre, Klinikum Würzburg Mitte, Standort Juliusspital, Germany.
16
Federal University of Sao Paulo, Brazil.
17
Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora.
18
Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora.

Abstract

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.

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