A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy
This protocol is a Phase III study to assess the efficacy, safety, and immunogenicity of V212 inactivated by gamma irradiation in a larger population of adults with HM or STM receiving chemotherapy. The study will be conducted using a 4-dose regimen administered ~30 days apart, consistent with the vaccine regimen used in the Phase I
study, Protocol 002 (rationale for the 4-dose regimen is provided in Section 220.127.116.11). The study will expand upon the experience of the earlier studies, including the POC studies and P002, which suggested that inactivated VZV vaccine administered as a 4-dose regimen is well-tolerated and immunogenic, and could provide substantial reduction in HZ incidence in HM and STM patients.
Approximately 5264 patients (~2568 HM patients; ~2696 STM patients), 18 years of age or older will be equally randomized to receive a 4-dose regimen of either V212 or placebo. Patient allocation will be double-blinded, with in-house blinding procedures. Enrollment for this study is expected to be completed in approximately 36 months. Study
duration is anticipated to be approximately 5 years.
An individual will be eligible to participate in this study if all of the following criteria apply:
1. Patient has been diagnosed with a solid tumor or hematologic malignancy AND is not likely to undergo hematopoietic cell transplant (HCT) and meets one of the criteria specified below.
Is 18 years of age or older and is receiving a cytotoxic or immunosuppressive chemotherapy regimen.
2. Is 50 years of age or older with a hematologic malignancy, not in remission, regardless of whether the patient is or is not receiving chemotherapy
2. Life expectancy ≥ 12 months.
3. Signed an informed consent prior to any study procedures.
4. Patient has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence (for ≥30 years) in a country with endemic VZV infection, or if participant is 30 years old, attended primary or secondary school in a country with endemic VZV infection (see Section 3.2.8 for more details).
5. All female patients of childbearing potential (as defined below under #7) must have a negative serum or urine pregnancy test (sensitive to 25IU β-hCG).
6. Able to understand and complete study questionnaires.
7. Patient is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from the last vaccination dose, as indicated by at least one "yes" answer to the following questions:
• Patient is male.
• Patient is female who agrees to remain abstinent or use (or have their partner use) adequate contraception during the time period starting 2 weeks prior to enrollment through 6 months from the last vaccination dose. Note that simultaneous use of two reliable forms of contraception is recommended.
• Patient is a female who is not of reproductive potential. A female patient who is not of reproductive potential is defined as: one who has either (1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone [FSH] levels in the postmenopausal range as determined by a laboratory, or 12 months of spontaneous amenorrhea), (2) postsurgical bilateral oophorectomy and/or hysterectomy, or (3) bilateral tubal ligation
8. Patients with STM will be eligible for enrollment if they have not received (nor are expected to require receipt of) blood products within 3 months prior to enrollment through 28 days Postvaccination 4.