Safety and Immunogenicity of Heat-Treated Zoster Vaccine (ZVHT) in Immunocompromised Adults
| Autor: | Paula W. Annunziato, Donald M. Poretz, Michael R. Mullane, Jon E. Stek, Michael S. Wertheim, Tina M. Sterling, Yanli Zhao, Steven A. Pergam, Drew J. Winston, Susan B. Manoff, Luis H. Camacho, Kathleen M. Mullane, Robert F. Betts |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
Adult
Male medicine.medical_specialty Population HIV Infections Vaccines Attenuated Malignancy Placebo Herpes Zoster Gastroenterology Virus Immunocompromised Host Young Adult Double-Blind Method Neoplasms Internal medicine medicine Herpes Zoster Vaccine Humans Immunology and Allergy education Aged Aged 80 and over education.field_of_study biology business.industry Immunogenicity ELISPOT Vaccination Hematopoietic Stem Cell Transplantation Middle Aged medicine.disease Treatment Outcome Infectious Diseases biology.protein Female Zoster vaccine Antibody business medicine.drug |
| Zdroj: | The Journal of Infectious Diseases. 208:1375-1385 |
| ISSN: | 1537-6613 0022-1899 |
| DOI: | 10.1093/infdis/jit344 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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