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Clinical Trial
. 2021 Oct 1;105(10):2316-2323.
doi: 10.1097/TP.0000000000003621.

Evaluation of Recombinant Herpes Zoster Vaccine for Primary Immunization of Varicella-seronegative Transplant Recipients

Arnaud G L'Huillier  1 , Cedric Hirzel  2 , Victor H Ferreira  3 , Matthew Ierullo  3 , Terrance Ku  3 , Nazia Selzner  3 , Jeffrey Schiff  3 , Stephen Juvet  3 , Congrong Miao  4 , D Scott Schmid  4 , Atul Humar  3 , Deepali Kumar  3
Affiliations
Free article
Clinical Trial

Evaluation of Recombinant Herpes Zoster Vaccine for Primary Immunization of Varicella-seronegative Transplant Recipients

Arnaud G L'Huillier et al. Transplantation. .
Free article

Abstract

Background: Immunization of varicella-zoster virus (VZV)-seronegative solid organ transplant (SOT) patients using the live-attenuated varicella vaccine is generally contraindicated, leaving no widely applicable immunization option. The recombinant subunit herpes zoster vaccine (RZV) is indicated for VZV-seropositive persons to prevent shingles but could potentially also protect VZV-seronegative persons against varicella. We performed a safety and immunogenicity evaluation of RZV in VZV-seronegative SOT recipients as an option for protection.

Methods: VZV-seronegative adult SOT patients with no history of varicella/shingles vaccine or disease were given 2 doses of RZV vaccine 2-6 mo apart. Blood was drawn prevaccination (V1), before the second dose (V2), and 4 wk after the second dose (V3). Humoral immunity (anti-glycoprotein E) and cell-mediated immunity were evaluated, with polyfunctional cells defined as cells producing ≥2 cytokines.

Results: Among 31 eligible VZV-seronegative SOT patients screened, 23 were enrolled. Median age was 38 y and median time since transplant procedure was 3.8 y. The most frequent transplant types were liver (35%) and lung (30%). Median anti-glycoprotein E levels significantly increased from V1 to V3 (P = 0.001) and V2 to V3 (P < 0.001), even though only 55% had a positive seroresponse. Median polyfunctional CD4 T-cell counts increased from V1 to V2 (54/106 versus 104/106 cells; P = 0.041) and from V2 to V3 (380/106; P = 0.002). Most adverse events were mild with no rejection episodes.

Conclusions: RZV was safe and elicited significant humoral and cellular responses in VZV-seronegative SOT patients and has the potential to be considered as a preventive strategy against primary varicella.

Trial registration: ClinicalTrials.gov NCT03685682.

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Conflict of interest statement

D.K. has received clinical trials grant and consulting fees from GSK. The other authors declare no conflicts of interest.

References

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    1. Lynfield R, Herrin JT, Rubin RH. Varicella in pediatric renal transplant recipients. Pediatrics. 1992;90(Pt 1):216–220.
    1. Fehr T, Bossart W, Wahl C, et al. Disseminated varicella infection in adult renal allograft recipients: four cases and a review of the literature. Transplantation. 2002;73:608–611.
    1. Gourishankar S, McDermid JC, Jhangri GS, et al. Herpes zoster infection following solid organ transplantation: incidence, risk factors and outcomes in the current immunosuppressive era. Am J Transplant. 2004;4:108–115.
    1. Fuks L, Shitrit D, Fox BD, et al. Herpes zoster after lung transplantation: incidence, timing, and outcome. Ann Thorac Surg. 2009;87:423–426.

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