A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Participants Undergoing Hematopoietic Cell Transplants (HCTs) (Study No. V212-001 AM4)
Status: | Completed |
---|---|
Conditions: | Shingles, Infectious Disease |
Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2013 |
Start Date: | November 2010 |
End Date: | August 2014 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
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)
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).
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
50
sites
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