Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01137669
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2010-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ZOSTAVAX® in Renal Transplant Patients
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
Phase I Trial of ZOSTAVAX® Prior to Renal Transplantation
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
Infection with varicella-zoster virus (VZV) produces a life-long latent infection in sensory ganglia. Reactivation of viral replication from latency results in a number of clinical syndromes, most commonly herpes zoster, or shingles. Herpes zoster is typically a unilateral vesicular rash in a dermatomal distribution accompanied by radicular pain that may be severe. Immunocompromised persons are at higher risk for herpes zoster than immunocompetent adults. The markedly increased risk of herpes zoster in organ transplant recipients suggests that this population would benefit substantially if a similar strategy could be adopted. The currently licensed zoster vaccine, ZOSTAVAX® (Zoster Vaccine Live), is not licensed for use in immunosuppressed persons and in the United States for those less than 50 years of age. A small Phase I study is important to address immunogenicity in patients with Chronic Kidney Disease (CKD) prior to transplantation as well as safety and persistence of immune responses following transplantation. This study is a multi-center, double blind, randomized, placebo-controlled trial of ZOSTAVAX® immunization in subjects who will undergo renal transplantation from a living donor or are wait-listed for a deceased donor no less than 4 weeks prior to transplantation. The primary objective of this study is to assess the safety of ZOSTAVAX® when administered to subjects with CKD a minimum of 4 weeks prior to live donor renal transplantation. This will be accomplished by comparing the rates of specific local and systemic reactogenicity events and adverse events (AEs) between the vaccine and placebo groups. Subjects likely to be suitable for renal transplant and who have an identified living donor will be consented for screening serology for antibodies to VZV if such serology is not standard of care or serostatus is not known. Subjects with positive VZV serology, an identified living donor, and meeting inclusion and exclusion criteria will provide signed informed consent for study enrollment. Subjects will be randomized to receive either active vaccine (ZOSTAVAX®) \[30 subjects\] or placebo vaccine \[10 subjects\]. Blood will be drawn on day 0 (day of vaccine) prior to vaccine administration for assessment of baseline humoral and cellular immunity to VZV. Subjects will receive ZOSTAVAX® or placebo vaccination. At approximately 5 weeks post-vaccination, subjects will have blood drawn for measurement of humoral and cellular immune response. Subjects will undergo living donor renal transplant with immunosuppression according to standard of care at each institution. All transplanted subjects will receive anti-viral prophylaxis for 3 months post-transplant, consisting of either valganciclovir (or ganciclovir) or acyclovir (or valacyclovir or famciclovir) depending on risk of cytomegalovirus (CMV) disease. Subjects will be followed and treated by the renal transplant team at each center according to local standard of care with concomitant monitoring by the vaccine study teams. Subjects will have blood drawn for humoral and cell-mediated immune assays at day 0, and week 5 post vaccination, and 6 months and 12 months post-transplantation if they undergo transplantation. Parent protocol to sub-study 09-0025.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: