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 Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011)
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster; Neoplasms; Hematologic Neoplasms
Intervention: V212; Placebo
Intervention description: V212 viral antigen for HZ, 0.5 mL subcutaneous (SC) injection per dose, in a four dose regimen, approximately 30 days apart.; Vaccine stabilizer for V212 with no virus antigen, 0.5 mL SC injection per dose, in a four dose regimen, approximately 30 days apart.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5305.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Herpes zoster; vaccine; herpes-zoster-related complications; immunocompromised; herpes zoster-associated pain; solid tumor malignancy; hematologic malignancy

Summary:

      This is a randomized, double-blind, placebo-controlled study to assess the safety and
      tolerability of V212 when administered to adults with solid tumor malignancy (STM) receiving
      chemotherapy and to assess the impact of V212 on the development of herpes zoster (HZ) in
      adults with STM receiving chemotherapy. The primary hypothesis is that vaccination with V212
      will reduce the incidence of HZ compared with placebo in adults with STM (lower bound of the
      97.5% {one-sided α=0.0125} confidence interval [CI] for the estimated vaccine efficacy in
      adults with STM be >25%).

      Participants with hematologic malignancy (HM) were also enrolled and were to be originally
      included in the primary and secondary objectives and analyses. After an interim analysis
      demonstrated clear evidence of futility of V212 in the HM population, enrollment of this
      population was stopped and all HM-related objectives and analyses were made exploratory and
      are not reported in this record.
    

Eligibility criteria:

        Inclusion criteria:

          -  Has been diagnosed with an STM or HM and is not likely to undergo hematopoietic cell
             transplant (HCT) and is either ≥18 years of age and receiving a cytotoxic or
             immunosuppressive chemotherapy regimen OR is ≥ 50 years of age with a hematologic
             malignancy that is not in remission, whether on therapy or not

          -  Life expectancy ≥12 months

          -  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

          -  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

          -  Has received or is expected to receive any varicella or non-study zoster vaccine

          -  Currently receiving or expected to receive long-term antiviral prophylaxis (>4 weeks
             duration) with activity against herpes simplex virus (HSV), VZV or cytomegalovirus
             (CMV)

          -  Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks
             prior to enrollment throughout 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