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
- To help determine how well this vaccine is tolerated by autologous bone marrow or stem cell transplant patients.
- To determine if the study vaccine will provide protection against herpes zoster (shingles) for recipients of autologous bone marrow or stem cell transplants.
- 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
- Be 18 years or older
- Scheduled to undergo Autologous Bone Marrow or Stem Cell Transplant
- Have a prior history of varicella
You must not
- Have a prior history of hypersensitivity to any vaccine component
- Be pregnant or breastfeeding
- Have had shingles in the past 12 months
- Ever received chickenpox or shingles vaccine
» What you will be asked to do if you agree to participate
- 5 appointments at Mount Sinai Hospital over a 5-month period and then yearly visits for 5 years
- Injection of study vaccine once monthly for 4 months
- Blood samples once every month for 5 months and then yearly for 5 years
- Record of daily temperature, medications, and bad effects in a study diary
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
People with weakened immune systems
- Are more likely to have severe complications from shingles
- Cannot receive the standard herpes zoster vaccine
Dr. Allison McGeer
Dr. Donna Reece
This website has been made possible through an unrestricted educational grant from
Pfizer Canada Inc.