Bone Marrow Transplant
V212 for Recipients of Autologous Hematopoietic Cell Transplants (2472)
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)
|Closed||Herpes Zoster||Phase III||
This is a study to determine whether investigational V212 reduces the incidence of herpes zoster (HZ) compared to placebo when administered to recipients of autologous hematopoietic cell transplants (HCT).
Eligibility Criteria (must meet the following to participate in this study)
- Men and women at least 18 years of age
- Has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence in a country with endemic VZV infection for ≥30 years or if participant is <30 years old, attended primary or secondary school in a country with endemic VZV infection.
- Scheduled to undergo an autologous hematopoietic cell transplant within 60 days of enrollment
- Is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from last vaccination dose
- Female participants of childbearing potential must have a negative serum or urine pregnancy test.
Exclusions (conditions that would prevent participation in this study)
- History of hypersensitivity reaction to any vaccine component
- Prior history of herpes zoster within 1 year of enrollment
- Prior receipt of any varicella or zoster vaccine
- More than 2 relapses of the underlying cancer (participants with Hodgkin's lymphoma may have had more than 2 relapses)
- Expectation of tandem transplant procedure
- Is expected to receive >6 months (>180 days) of prophylactic antiviral therapy post-HCT.
- Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment through 6 months from last vaccination dose.
- Has received a live virus vaccine or is scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days Postdose 4.
- Has received an inactivated vaccine or is scheduled to receive an inactivated vaccine in the period between 7 days prior to and 28 days following Doses 1 through 4.
Last UpdatedJune 20, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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