Bone Marrow Transplant
|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).
- 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.
- 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.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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