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Infection Control

V212 for Herpes Zoster in Patients with Solid Tumor or Hematologic Malignancies
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
Status Conditions Phase Study ID
Recruiting Herpes Zoster Phase III 2593
NCT01254630
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) 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.


Investigator
Michael Boeckh, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Participant has been diagnosed with an STM or HM and is not likely to undergo hematopoietic cell transplant (HCT) and:
  • Participant is ≥18 years of age and receiving a cytotoxic or immunosuppressive chemotherapy regimen
  • Participant is ≥ 50 years of age with a hematologic malignancy that is not in remission, whether on therapy or not
  • Participant has a life expectancy ≥ 12 months.
  • Participant has prior history of varicella or antibodies to VZV due to exposure to the disease in a country where the disease is common.
Exclusions (conditions that would prevent participation in this study)
  • Participant has a history of allergic reaction to any vaccine component (including gelatin) or ananaphylactic/anaphylactoid reaction to neomycin.
  • Participant has a prior history of HZ within 1 year of enrollment.
  • Participant has received or is expected to receive any varicella or non-study zoster vaccine.
  • Participant is currently receiving or expected to receive long-term antiviral prophylaxis (>4 weeks duration) with activity against herpes simplex virus (HSV), VZV or cytomegalovirus (CMV)
  • Participant is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months after last vaccination dose.
  • Participant has 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
  • Participant has had inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.
Last Updated
October 25, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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