title: Safety and immunogenicity of heat-treated zoster vaccine (ZVHT) in immunocompromised adults.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Chicago Medical Center, Illinois.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Mullane
authors.forename: Drew J
authors.initials: DJ
authors.lastname: Winston
authors.forename: Michael S
authors.initials: MS
authors.lastname: Wertheim
authors.forename: Robert F
authors.initials: RF
authors.lastname: Betts
authors.forename: Donald M
authors.initials: DM
authors.lastname: Poretz
authors.forename: Luis H
authors.initials: LH
authors.lastname: Camacho
authors.forename: Steven A
authors.initials: SA
authors.lastname: Pergam
authors.forename: Michael R
authors.initials: MR
authors.lastname: Mullane
authors.forename: Jon E
authors.initials: JE
authors.lastname: Stek
authors.forename: Tina M
authors.initials: TM
authors.lastname: Sterling
authors.forename: Yanli
authors.initials: Y
authors.lastname: Zhao
authors.forename: Susan B
authors.initials: SB
authors.lastname: Manoff
authors.forename: Paula W
authors.initials: PW
authors.lastname: Annunziato
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000276:immunology*; D018380:Hematopoietic Stem Cell Transplantation; D006562:Herpes Zoster / Q000517:prevention & control*; D053061:Herpes Zoster Vaccine / Q000009:adverse effects* / Q000276:immunology; D006801:Humans; D016867:Immunocompromised Host; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000276:immunology* / Q000628:therapy; D016896:Treatment Outcome; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D053061:Herpes Zoster Vaccine; D014613:Vaccines, Attenuated
keywords: herpes zoster; immunocompromised adults; zoster vaccine