Trial Search Results

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)

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Merck Sharp & Dohme Corp.

Stanford Investigator(s):

Intervention(s):

  • Biological: V212
  • Biological: Matching placebo

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Janice Smith-Williams
6507244155
Not Recruiting