Phase I Trial of ZOSTAVAX® Prior to Renal Transplantation

Inclusion Criteria:

- Subjects must be willing and able to provide informed consent prior to study
procedures.

- Age 18 years or older at the time of vaccination.

- Chronic kidney disease (CKD) activated on the United Network for Organ Sharing (UNOS)
deceased donor waitlist or anticipating living donor renal transplant no sooner than
4 weeks following vaccination.

- Varicella Zoster Virus (VZV) seropositive by local laboratory or Center for Disease
Control (CDC) serologic testing

- Negative pregnancy test (women of childbearing age potential) performed at
enrollment- or within 48 hours prior. The use of contraception for women of
childbearing potential will be per renal transplant team's standard of care

Exclusion Criteria:

- Any pharmacologic immunosuppression at the time of enrollment, within one year prior
to enrollment, or between enrollment and transplant (e.g., for underlying autoimmune
disease or previous failed allograft). This includes prednisone at >/= 0.3 mg/kg/day
or steroid equivalent for > 10 days, any use of anti-metabolites (azathioprine,
mycophenolic acid, cytoxan), leflunomide, TNF-alpha inhibitors, calcineurin
inhibitors, mTOR inhibitors, IL-6 or IL-6 receptor inhibitors.

- Any transplant other than solitary kidney (e.g., no kidney/pancreas, kidney/liver
transplants). Second kidney transplants are permitted.

- Anticipated use of any post-transplant experimental immunosuppressive agent

- Prior ZOSTAVAX® or Varivax® vaccination

- Shingles or any other herpes zoster within 12 months of planned vaccination

- Receipt of any killed vaccines within 4 weeks or receipt of live vaccines within 6
weeks following study vaccination

- Intercurrent illness at time of planned vaccination

- Inability to vaccinate in either arm (e.g. due to A-V fistula or graft)

- Known Human immunodeficiency virus (HIV) infection, Hepatitis C virus (HCV)
infection, or chronic hepatitis B determined from review of laboratory data obtained
from pre-transplant evaluation by renal transplant team. Note positive IgG hepatitis
B surface antibody alone (negative HBcAb and negative IgM) is indicative of vaccine
induced immunity and is not grounds for exclusion

- History of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other
components of the vaccine

- Asthma requiring systemic or inhaled steroid treatment within 12 months prior to
enrollment

- Allergy to ganciclovir, valgancyclovir, acyclovir, or famciclovir

- Panel Reactive Antibody (PRA) >/= 20 percent or donor-specific sensitization (by
solid phase assay or flow cytometry) or treatment with intravenous immunoglobulin
(IVIG) for desensitization prior to transplant

- History of primary or acquired immunodeficiency states.

- Routine use of anti-viral prophylaxis for Herpes Simplex Virus (HSV) at the time of
vaccination or within 3 months prior

- Any other condition that in the opinion of the investigator might interfere with the
subject's safety or ability to participate in the study

- Abnormal screening laboratory data resulting in a disqualification of transplant
candidacy. Abnormalities due to underlying disease (e.g., renal failure, anemia,
hyperlipidemia, cardiovascular disease, diabetes) are not exclusionary except as
denoted above for HIV, hepatitis B, hepatitis C, autoimmune disease.

- The subject is currently participating in a study that involves an experimental agent
(vaccine, drug, biologic, device, blood product, or medication) or has received an
experimental agent within 1 month prior to enrollment in this study, or expects to
receive another experimental agent during participation in this study.

- The subject has a diagnosis of schizophrenia, bi-polar disease, or other severe
(disabling) psychiatric diagnosis identified at the pre-transplant evaluation.

- The subject has been hospitalized within the past 5 years prior to enrollment for
psychiatric illness, history of suicide attempt or confinement for danger to self or
others identified at the pre-transplant evaluation.

- Dual listing at more than one transplant center.

- Unwilling to be temporarily inactivated on UNOS wait list for 4 weeks post
vaccination.