Immunogenicity of Inactivated Varicella Zoster Vaccine in Autologous Hematopoietic Stem Cell Transplant Recipients and Patients With Solid or Hematologic Cancer.

Autor: Boeckh MJ; Vaccine and Infectious Disease & Clinical Research Divisions, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA., Arvin AM; Microbiology & Immunology Departments, Stanford University School of Medicine, Stanford, California, USA., Mullane KM; Department of Medicine, University of Chicago, Chicago, Illinois, USA., Camacho LH; Medical Oncology, Oncology Consultants, Houston, Texas, USA., Winston DJ; Department of Medicine, University of California Los Angeles Medical Center, Los Angeles, California, USA., Morrison VA; Hematology Oncology Division, Hennepin County Medical Center, University of Minnesota, Minneapolis, Minnesota, USA., Hurtado K; Merck & Co., Inc., Kenilworth, New Jersey, USA., Durrand Hall J; Merck & Co., Inc., Kenilworth, New Jersey, USA., Pang L; Merck & Co., Inc., Kenilworth, New Jersey, USA., Su SC; Merck & Co., Inc., Kenilworth, New Jersey, USA., Kaplan SS; Merck & Co., Inc., Kenilworth, New Jersey, USA., Annunziato PW; Merck & Co., Inc., Kenilworth, New Jersey, USA., Popmihajlov Z; Merck & Co., Inc., Kenilworth, New Jersey, USA.
Jazyk: angličtina
Zdroj: Open forum infectious diseases [Open Forum Infect Dis] 2020 Jun 02; Vol. 7 (7), pp. ofaa172. Date of Electronic Publication: 2020 Jun 02 (Print Publication: 2020).
DOI: 10.1093/ofid/ofaa172
Abstrakt: Background: In phase 3 trials, inactivated varicella zoster virus (VZV) vaccine (ZV IN ) was well tolerated and efficacious against herpes zoster (HZ) in autologous hematopoietic stem cell transplant (auto-HSCT) recipients and patients with solid tumor malignancies receiving chemotherapy (STMc) but did not reduce HZ incidence in patients with hematologic malignancies (HMs). Here, we describe ZV IN immunogenicity from these studies.
Methods: Patients were randomized to ZV IN or placebo (4 doses). Immunogenicity was assessed by glycoprotein enzyme-linked immunosorbent assay (gpELISA) and VZV interferon (IFN)-γ enzyme-linked immunospot (ELISPOT) assay in patients receiving all 4 doses without developing HZ at the time of blood sampling.
Results: Estimated geometric mean fold rise ratios (ZV IN /placebo) by gpELISA and IFN-y ELISPOT ~28 days post-dose 4 were 2.02 (95% confidence interval [CI], 1.53-2.67) and 5.41 (95% CI, 3.60-8.12) in auto-HSCT recipients; 1.88 (95% CI, 1.79-1.98) and 2.10 (95% CI, 1.69-2.62) in patients with STMc; and not assessed and 2.35 (95% CI, 1.81-3.05) in patients with HM.
Conclusions: ZV IN immunogenicity was directionally consistent with clinical efficacy in auto-HSCT recipients and patients with STMc even though HZ protection and VZV immunity were not statistically correlated. Despite a lack of clinical efficacy in patients with HM, ZV IN immunogenicity was observed in this population. Immunological results did not predict vaccine efficacy in these 3 populations.
Clinical Trial Registration: NCT01229267, NCT01254630.
(© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze: MEDLINE
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