Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study

J Infect Dis. 2015 Apr 15;211(8):1279-87. doi: 10.1093/infdis/jiu606. Epub 2014 Nov 3.


Background: Human immunodeficiency virus (HIV)-infected individuals are at increased risk of herpes zoster (HZ), even in the antiretroviral therapy (ART) era. Because concerns exist about the use of live-attenuated vaccines in immunocompromised individuals, a subunit vaccine may be an appropriate alternative.

Methods: This phase 1/2, randomized, placebo-controlled study evaluated the immunogenicity and safety of an investigational HZ subunit vaccine (HZ/su). Three cohorts of HIV-infected adults aged ≥18 years were enrolled: 94 ART recipients with a CD4(+) T-cell count of ≥200 cells/mm(3), 14 ART recipients with a CD4(+) T-cell count of 50-199 cells/mm(3), and 15 ART-naive adults with a CD4(+) T-cell count of ≥500 cells/mm(3). Subjects received 3 doses of HZ/su (50 µg varicella-zoster virus glycoprotein E [gE] combined with AS01B adjuvant) or 3 doses of saline at months 0, 2, and 6.

Results: One month after dose 3, serum anti-gE antibody concentrations and frequencies of gE-specific CD4(+) T cells were higher following HZ/su vaccination than after receipt of saline (P < .0001). Median cell-mediated immune responses peaked after dose 2. Humoral and cell-mediated immune responses persisted until the end of the study (month 18). No vaccination-related serious adverse events were reported. No sustained impact on HIV load or CD4(+) T-cell count was noted following vaccinations.

Conclusions: HZ/su was immunogenic and had a clinically acceptable safety profile in HIV-infected adults.

Clinical trials registration: NCT01165203.

Keywords: HIV infection; glycoprotein E; herpes zoster; immunodeficiency; varicella-zoster virus; zoster vaccine.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / pharmacology*
  • Adjuvants, Pharmaceutic / pharmacology
  • Antibodies, Viral / immunology
  • Antibody Formation / immunology*
  • CD4-Positive T-Lymphocytes / immunology
  • Female
  • HIV Infections / immunology*
  • Herpes Zoster / immunology*
  • Herpes Zoster Vaccine / immunology*
  • Herpesvirus 3, Human / immunology*
  • Humans
  • Male
  • Middle Aged
  • Vaccination / methods
  • Vaccines, Subunit / immunology*


  • Adjuvants, Immunologic
  • Adjuvants, Pharmaceutic
  • Antibodies, Viral
  • Herpes Zoster Vaccine
  • Vaccines, Subunit

Associated data