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) (V212-001)
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: V212; Matching placebo
Intervention description: V212 viral antigen for HZ. Participants will receive consistency Lot 1, 2, or 3 or the High Antigen Lot.; Vaccine stabilizer for V212 with no virus antigen
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1257.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Herpes zoster; vaccine; herpes zoster-related complications; immunocompromised; autologous hematopoietic cell transplants

Summary:

      This is a randomized, double-blind, placebo-controlled study to assess the safety and
      efficacy of inactivated VZV vaccine for the prevention of HZ and HZ-related complications in
      adult recipients of autologous hematopoietic cell transplants (HCTs). The primary hypothesis
      is that vaccination with V212 vaccine will reduce the incidence of herpes zoster (HZ)
      compared to placebo when administered to recipients of HCT. The statistical criterion for
      success requires that the lower bound of the 95% confidence interval for the estimated
      vaccine efficacy in the V212 recipients (excluding the high-antigen lot) compared with that
      in the placebo recipients is >25%.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.