ZOSTAVAX® in Renal Transplant Patients
|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
|Condition or disease||Intervention/treatment||Phase|
|Herpes Zoster||Biological: Live attenuated herpes zoster vaccine Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Phase I Trial of ZOSTAVAX® Prior to Renal Transplantation|
|Study Start Date :||September 2010|
|Primary Completion Date :||February 2015|
|Study Completion Date :||February 2015|
Placebo Comparator: Placebo
10 subjects to receive placebo subcutaneously.
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.
30 subjects to receive 0.65 mL ZOSTAVAX® subcutaneously.
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 The entire contents of the reconstituted vaccine vial (approximately 0.65 mL) will be withdrawn into a syringe.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.
- 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. ]
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|