Swedish Medical Center Seattle

CRC 11055: 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

Type of Study

Cancer (Oncology) - Solid Tumor or Hematologic Malignancy

Location

Short Description

Purpose: 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) or hematologic malignancy (HM) and to determine whether V212 reduces the incidence of herpes zoster (HZ) in adults with STM or HM, as compared to placebo.

Status

Open to Enrollment

Principal Investigator

Henry Kaplan, M.D.

Eligibility Notes

Participant has been diagnosed with a solid tumor malignancy (STM) or hematologic malignancy (HM) and is not likely to undergo hematopoietic cell transplant (HCT) and:
- ≥18 years of age and receiving a cytotoxic or immunosuppressive chemotherapy regimen that does not include rituximab.
- ≥ 50 years of age with a hematologic malignancy that is not in remission, whether on therapy or not, and is not expected to need rituximab therapy within 3 months prior to enrollment on this study through 28 days after receiving vaccination dose 4.
- Life expectancy ≥ 12 months.
- Must have prior history of varicella or antibodies to VZV due to exposure to the disease in a country where the disease is common.
- Must have a history of allergic reaction to any vaccine component (including gelatin) or an anaphylactic/anaphylactoid reaction to neomycin.
No prior history of herpes zoster within 1 year of enrollment.
No prior any varicella or zoster vaccine.
May not be currently receiving or expected to receive long-term antiviral prophylaxis (>4 weeks duration) with activity against herpes simplex virus (HSV), VZV or cytomegalovirus (CMV).
May not be receiving or expected to receive a chemotherapy regimen containing Rituximab.
May not have had any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days post vaccination dose 4.
May not have had inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.

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