ZOSTAVAX® in Renal Transplant Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01137669 |
Recruitment Status
:
Completed
First Posted
: June 4, 2010
Last Update Posted
: January 9, 2017
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Condition or disease | Intervention/treatment | Phase |
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Herpes Zoster | Biological: Live attenuated herpes zoster vaccine Other: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Phase I Trial of ZOSTAVAX® Prior to Renal Transplantation |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | February 2015 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
10 subjects to receive placebo subcutaneously.
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Other: Placebo
Placebo for Zoster Vaccine Live (ZOSTAVAX®) is sterile normal saline which will be obtained from the Fisher Repository in single-dose containers. 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. The placebo will be administered subcutaneously in the deltoid region.
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Experimental: ZOSTAVAX®
30 subjects to receive 0.65 mL ZOSTAVAX® subcutaneously.
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Biological: Live attenuated herpes zoster vaccine
ZOSTAVAX® (Zoster Vaccine Live) is a live attenuated vaccine provided as a single-dose, sterile, lyophilized, preservative-free frozen formulation. The vaccine will be supplied in 3-mL glass vials. Sterile diluent will be used to reconstitute study vaccine. The reconstituted vial will be gently agitated to mix thoroughly. The entire contents of the reconstituted vaccine vial (approximately 0.65 mL) will be withdrawn into a syringe. The vaccine will be administered immediately subcutaneously in the deltoid region.
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- Biopsy proven graft rejection [ Time Frame: During 12 months post- vaccination or post- transplantation ]
- Safety: any occurrence of proven [polymerase chain reaction (PCR) confirmed] vaccine strain varicella zoster virus (VZV) infection at any site not contiguous with the injection site. [ Time Frame: Entire post-immunization period up to 12 months following transplantation. ]
- Safety: incidence of grade 3 or higher vaccine related adverse events (AEs) and vaccine related serious adverse events (SAEs). [ Time Frame: During the 4 weeks post-immunization. ]
- Safety: incidence of vaccine related serious adverse events (SAEs). [ Time Frame: During 12 months post- vaccination or post-transplantation ]
- Safety: increase of panel reactive antibody (PRA) by greater than or equal to 10% (e.g., from 10% to 20%) or newly positive donor specific cross match (DXM) after immunization in the absence of any other attributable cause. [ Time Frame: Prior to vaccination, to following vaccination while on the wait list (for up to 12 months) ]
- Safety: increase of panel reactive antibody (PRA) by greater than or equal to 10% (e.g., from 10% to 20%) or newly positive donor specific cross match (DXM) prior to transplantation in the absence of any other attributable cause. [ Time Frame: Study Day 0, through Study Day 35 post vaccination, or to the time of transplantation in those subjects who are transplanted. The ideal time for transplantation is 6 weeks post vaccination. ]
- Immune response: changes from baseline glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) varicella zoster virus (VZV) antibody titer. [ Time Frame: Approximately 5 weeks post immunization, 6 months and 12 months post-vaccination or 6 months and 12 months post-transplantation.If transplantation occurs >12 weeks post-vaccination, a repeat pre-transplant baseline is optional. ]
- Immune response: changes from baseline number of VZV specific T cells by flow cytometry measuring intracellular interleukin-2 (IL-2), interferon (IFN)-gamma, and tumor necrosis factor (TNF)-alpha after stimulation with VZV antigens. [ Time Frame: Approximately 5 weeks post-immunization, 6 months and 12 months post-immunization or post-transplantation. If transplantation occurs >12 weeks post-vaccination, a repeat pre-transplant baseline is optional. ]

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137669
United States, Iowa | |
University of Iowa - Vaccine Research and Education Unit | |
Iowa City, Iowa, United States, 52242-2600 | |
United States, Maryland | |
University of Maryland Baltimore - School of Medicine - Medicine | |
Baltimore, Maryland, United States, 21201-1509 | |
United States, Tennessee | |
Vanderbilt University - Medicine - Infectious Diseases | |
Nashville, Tennessee, United States, 37232-2035 |
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT01137669 History of Changes |
Other Study ID Numbers: |
09-0016 |
First Posted: | June 4, 2010 Key Record Dates |
Last Update Posted: | January 9, 2017 |
Last Verified: | October 2015 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
immunocompromised,parent protocol,shingles,varicella-zoster virus,ZOSTAVAX® |
Additional relevant MeSH terms:
Herpes Zoster Herpesviridae Infections DNA Virus Infections Virus Diseases |
Vaccines Immunologic Factors Physiological Effects of Drugs |