Safety and immunogenicity of heat-treated zoster vaccine (ZVHT) in immunocompromised adults

J Infect Dis. 2013 Nov 1;208(9):1375-85. doi: 10.1093/infdis/jit344. Epub 2013 Aug 1.


Background: Safety and immunogenicity of heat-treated zoster vaccine (ZVHT) were assessed in immunocompromised adults.

Methods: In a randomized, double-blind, placebo-controlled, multicenter study, 4 doses ZVHT or placebo were administered approximately 30 days apart to adults with either solid tumor malignancy (STM); hematologic malignancy (HM); human immunodeficiency virus (HIV) with CD4(+) ≤200; autologous hematopoietic stem-cell transplant (HCT) or allogeneic-HCT recipients. Varicella-zoster virus (VZV) T-cell responses by interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) and VZV antibody concentrations by glycoprotein enzyme-linked immunosorbent assay (gpELISA) were measured at baseline and approximately 28 days after each dose.

Results: No safety signals were found in any group. IFN-γ ELISPOT geometric mean fold rises (GMFR) after dose 4 in STM, HM, HIV, and autologous-HCT patients were 3.00 (P < .0001), 2.23 (P = .004), 1.76 (P = .026), and 9.01 (P = NA), respectively. Similarly, antibody GMFR were 2.35 (P < .0001), 1.28 (P = .003), 1.37 (P = .017), and 0.90 (P = NA), respectively. T-cell and antibody responses were poor after 4 doses of ZVHT in allogeneic-HCT patients.

Conclusion: ZVHT was generally safe and immunogenic through 28 days post-dose 4 in adults with STM, HM, and HIV. Autologous-HCT but not allogeneic-HCT patients had a rise in T-cell response; antibody responses were not increased in either HCT population. Study identification. V212-002 Clinical Trials Registration. NCT00535236.

Keywords: herpes zoster; immunocompromised adults; zoster vaccine.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Double-Blind Method
  • Female
  • HIV Infections / immunology*
  • Hematopoietic Stem Cell Transplantation
  • Herpes Zoster / prevention & control*
  • Herpes Zoster Vaccine / adverse effects*
  • Herpes Zoster Vaccine / immunology
  • Humans
  • Immunocompromised Host*
  • Male
  • Middle Aged
  • Neoplasms / immunology*
  • Neoplasms / therapy
  • Treatment Outcome
  • Vaccination
  • Vaccines, Attenuated / adverse effects
  • Vaccines, Attenuated / immunology
  • Young Adult


  • Herpes Zoster Vaccine
  • Vaccines, Attenuated

Associated data