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Mount Sinai Hospital is a University of Toronto patient care, teaching, and research centre.
Mount Sinai Hospital is a University of Toronto patient care, teaching, and research centre.

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)

» Study Objectives

  1. To help determine how well this vaccine is tolerated by autologous bone marrow or stem cell transplant patients.
  2. To determine if the study vaccine will provide protection against herpes zoster (shingles) for recipients of autologous bone marrow or stem cell transplants.
  3. To assess how well the study vaccine works in patients with weakened immune systems who are receiving an autologous bone marrow or stem cell transplant.

» How the study works

To participate you must

  1. Be 18 years or older
  2. Scheduled to undergo Autologous Bone Marrow or Stem Cell Transplant
  3. Have a prior history of varicella

You must not

  1. Have a prior history of hypersensitivity to any vaccine component
  2. Be pregnant or breastfeeding
  3. Have had shingles in the past 12 months
  4. Ever received chickenpox or shingles vaccine

» What you will be asked to do if you agree to participate

  1. 5 appointments at Mount Sinai Hospital over a 5-month period and then yearly visits for 5 years
  2. Injection of study vaccine once monthly for 4 months
  3. Blood samples once every month for 5 months and then yearly for 5 years
  4. Record of daily temperature, medications, and bad effects in a study diary

» Participation

If you would like to learn more about the study, please email aAbdullayeva@mtsinai.on.ca

Or call Afat at 416-586-4800 ext. 2764, pager 416-380-5118

» Note

People with weakened immune systems

  1. Are more likely to have severe complications from shingles
  2. Cannot receive the standard herpes zoster vaccine

» Investigators

Dr. Allison McGeer

Dr. Donna Reece

This website has been made possible through an unrestricted educational grant from Pfizer Canada Inc.
Copyright 1999-2007 Department of Microbiology, Mount Sinai Hospital, Toronto, Canada. All rights reserved.