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

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 (≥50years). 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 3weeks 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.