Journal article
A randomized, placebo‐controlled phase I trial of live, attenuated herpes zoster vaccine in subjects with end‐stage renal disease immunized prior to renal transplantation
Transplant infectious disease, Vol.20(3), pp.e12874-n/a
06/2018
DOI: 10.1111/tid.12874
PMID: 29512282
Abstract
Background
Solid organ transplant recipients are at increased risk for reactivation of herpes zoster, or shingles, and have a higher frequency of serious complications including post‐herpetic neuralgia. A live, attenuated shingles vaccine is effective and approved for individuals 50 years and older. The vaccine is contraindicated following transplantation, but may be used in patients with renal failure. Utilization of the vaccine has been poor in patients with end‐stage renal disease, including those awaiting transplant, owing to concerns for safety, efficacy, and potential sensitization prior to transplant.
Methods
We conducted a phase I, randomized, placebo‐controlled study of the safety and immunogenicity of live, attenuated Oka strain shingles vaccine in subjects prior to or awaiting renal transplant at 3 US centers. Subjects received vaccine a minimum of 4 weeks prior to transplant.
Results
The vaccine was safe and well‐tolerated. There were no cases of herpes zoster or rash illness. There was no change in donor‐specific antibody or calculated panel reactive antibody after vaccination during the follow‐up period. There were no rejection episodes. There was a significant 2.1‐fold rise in geometric mean titer of anti‐VZV antibody at 5 weeks post‐vaccine.
Conclusions
The data suggest that the shingles vaccine is safe in subjects with ESRD awaiting transplant. Antibody responses were similar to those seen previously in adults >50 years of age and are consistent with a protective response.
Details
- Title: Subtitle
- A randomized, placebo‐controlled phase I trial of live, attenuated herpes zoster vaccine in subjects with end‐stage renal disease immunized prior to renal transplantation
- Creators
- Geraldine Miller - Vanderbilt University Medical CenterHeidi Schaefer - Vanderbilt University Medical CenterSandra Yoder - Vanderbilt University Medical CenterRachel Miller - Roy J. and Lucille A. Carver College of MedicinePatricia Winokur - Roy J. and Lucille A. Carver College of MedicineKaren Kotloff - University of Maryland School of MedicineDavid Klassen - University of Maryland, BaltimoreMichael Wierzbicki - Emmes (United States)Cyrille Amegashie - Emmes (United States)Kathryn Edwards - Vanderbilt University Medical Center
- Resource Type
- Journal article
- Publication Details
- Transplant infectious disease, Vol.20(3), pp.e12874-n/a
- DOI
- 10.1111/tid.12874
- PMID
- 29512282
- NLM abbreviation
- Transpl Infect Dis
- ISSN
- 1398-2273
- eISSN
- 1399-3062
- Number of pages
- 8
- Grant note
- NIAID DMID Vaccine Trial and Evaluation Units, NIH (HHSN272200800007C) Vanderbilt University (HHSN27220080000C) University of Maryland, Baltimore (HHSN272200800001C) University of Iowa (HHSN272200800008C; U54TR001356) CTSA (Clinical and Translational Science Awards) (UL1RR024975‐01)
- Language
- English
- Date published
- 06/2018
- Academic Unit
- Infectious Diseases; Medicine Administration; Internal Medicine
- Record Identifier
- 9984359669402771
Metrics
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