Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in chronically immunosuppressed adults following renal transplant : A phase 3, randomized clinical trial
| Autor: | Vink, P., Torrell, J.M.R., Fructuoso, A.S., Kim, Sung-Joo, Kim, Sang-Il, Zaltzman, J., Ortiz, F., Plana, J.M.C., Rodriguez, A.M.F., Rodrigo, H.R., Marti, M.C., Perez, R., Roncero, F.M.G., Kumar, D., Chiang, Y.-J., Doucette, K., Pipeleers, L., Morales, M.L.A., Rodriguez-Ferrero, M.L., Secchi, Antonio, McNeil, S.A., Campora, L., Di Paolo, E., El Idrissi, M., López-Fauqued, M., Salaun, B., Heineman, T.C., Oostvogels, L. |
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| Přispěvatelé: | Clinicum, HUS Abdominal Center |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
vomiting
Herpesvirus 3 Human drug safety myalgia glycoprotein E diarrhea gastrointestinal symptom Antibodies Viral Immunogenicity Vaccine recombinant vaccine humoral immunity calcineurin inhibitor Herpes Zoster Vaccine Herpes zoster vaccine kidney function fever 11832 Microbiology and virology Vaccines Synthetic adult creatinine Burkitt lymphoma immunosuppressive treatment clinical trial nausea Immunogenicity Renal transplant female priority journal kidney graft Varicella zoster virus injection site erythema mucosa inflammation Safety CD4 antigen bacterial meningitis injection site pain mycophenolic acid Adult corticosteroid side effect kidney transplantation herpes zoster cellular immunity antibody titer Herpes Zoster Article virus antibody injection site swelling shivering vaccine immunogenicity varicella zoster vaccine male Humans controlled study drug fatality human single blind procedure CD4+ T lymphocyte phase 3 clinical trial rapamycin abdominal pain immune deficiency vaccination graft recipient major clinical study Kidney Transplantation febrile neutropenia multicenter study randomized controlled trial placebo fatigue kidney graft rejection Immunosuppression |
| Popis: | Background. The incidence of herpes zoster is up to 9 times higher in immunosuppressed solid organ transplant recipients than in the general population. We investigated the immunogenicity and safety of an adjuvanted recombinant zoster vaccine (RZV) in renal transplant (RT) recipients ≥18 years of age receiving daily immunosuppressive therapy. Methods. In this phase 3, randomized (1:1), observer-blind, multicenter trial, RT recipients were enrolled and received 2 doses of RZV or placebo 1-2 months (M) apart 4-18M posttransplant. Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 T-cell frequencies, and vaccine response rates were assessed at 1M post-dose 1, and 1M and 12M post-dose 2. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days after each dose, respectively. Solicited general symptoms and unsolicited AEs were also collected 7 days before first vaccination. Serious AEs (including biopsy-proven allograft rejections) and potential immune-mediated diseases (pIMDs) were recorded up to 12M post-dose 2. Results. Two hundred sixty-four participants (RZV: 132; placebo: 132) were enrolled between March 2014 and April 2017. gE-specific humoral and cell-mediated immune responses were higher in RZV than placebo recipients across postvaccination time points and persisted above prevaccination baseline 12M post-dose 2. Local AEs were reported more frequently by RZV than placebo recipients. Overall occurrences of renal function changes, rejections, unsolicited AEs, serious AEs, and pIMDs were similar between groups. Conclusions. RZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M postvaccination. No safety concerns arose. © The Author(s) 2019. |
| Databáze: | OpenAIRE |
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