ZOSTAVAX® in Renal Transplant Patients

Completed · Phase 1 · Has a placebo group

Conditions studied: Herpes Zoster

In brief

The purpose of this study is to test the safety of a licensed zoster vaccine, ZOSTAVAX® (Zoster Vaccine Live) in 40 subjects, age 18 years or older, with chronic kidney disease (CKD) who are scheduled to receive a living donor kidney transplant. ZOSTAVAX® is not licensed for use in immunosuppressed persons and in the United States for individuals less than 50 years of age. Subjects will receive either ZOSTAVAX® vaccine or placebo (inactive substance) no less than 4 weeks prior to their kidney transplant. Study procedures include: physical exam, blood samples and documentation of daily temperatures and/or side effects in a diary following vaccination. Participants may be involved in study related procedures for up to 18 months.

Key facts

Study ID: NCT01137669
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 34
Starts: 2010-09-01
Expected to finish: 2015-02-01
Last updated by the study team: 2017-01-09

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 2 weeks prior and 4 weeks following study vaccination or receipt of any live vaccines within 4 weeks prior and 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.

Where it is running

University of Iowa - Vaccine Research and Education Unit — Iowa City, Iowa, United States
University of Maryland Baltimore - School of Medicine - Medicine — Baltimore, Maryland, United States
Vanderbilt University - Medicine - Infectious Diseases — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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