Safety and immunogenicity of adjuvanted recombinant subunit herpes zoster vaccine in lung transplant recipients.

Affiliation

Hirzel C(1)(2), L'Huillier AG(1)(3), Ferreira VH(1), Marinelli T(1), Ku T(1), Ierullo M(1), Miao C(4), Schmid DS(4), Juvet S(5), Humar A(1), Kumar D(1).
Author information:
(1)Transplant Infectious Diseases and Ajmera Transplant Centre, University Health Network, Toronto, ON, Canada.
(2)Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.
(3)Pediatric Infectious Diseases Unit, Department of Child and Adolescent Medicine, Geneva University Hospitals and Medical School, Geneva, Switzerland.
(4)Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
(5)Toronto Lung Transplant Program, University Health Network, Toronto, ON, Canada.

Abstract

Lung transplant recipients are at high risk for herpes zoster and preventive measures are a significant unmet need. We investigated the safety and immunogenicity of two doses of a recombinant zoster vaccine (RZV) in lung transplant recipients (≥50 years). We enrolled 50 patients of which 49 received at least one vaccine dose. Anti-glycoprotein E (gE) antibody levels (n = 43) increased significantly compared to baseline (median optical density [OD] 1.96; interquartile range [IQR]: 1.17-2.89) after the first (median OD 3.41, IQR 2.54-3.81, p < .0001) and second vaccine dose (median OD 3.63, IQR 3.39-3.86, p < .0001). gE-specific polyfunctional CD4+ T cell frequencies (n = 38) also increased from baseline (median 85 per 106 CD4+ T cells; IQR: 46-180) to the first (median 128 per 106 CD4+ T cells; IQR: 82-353; p = .023) and after the second dose (median 361 per 106 CD4+ T cells; IQR: 146-848; p < .0001). Tenderness (83.0%; 95%CI: 69.2-92.4%) and redness (31.9%; 95%CI: 19.1-47.1%) at injection site were common. One rejection episode within 3 weeks of vaccination was observed. This is the first study demonstrating that RZV was safe and elicited significant humoral and cell-mediated immunity in lung transplant recipients. RZV is a new option for the prevention of shingles in this population.