Protocol
11-065
Full Title
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)
Purpose
Patients who receive an autologous hematopoietic (stem) cell transplant (AHCT) have a 10 to 30 percent chance of getting shingles. Shingles can cause a rash that may be followed by nerve pain in the area where the rash healed, called postherpetic neuralgia, which can last for months or years.
The purpose of this study is to evaluate the effectiveness of an investigational vaccine, called V212, for protecting recipients of AHCT against shingles. This vaccine is similar to a marketed shingles and chicken pox vaccine, except that it has been modified to make it safe for people with weakened immune systems. Patients in this study will be randomly assigned to receive V212 or a placebo.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must be scheduled to undergo AHCT within 60 days of enrolling in the study.
- Patients should have had prior exposure to varicella-zoster, the virus that causes shingles, or lived in an area where exposure to this virus is common.
- Patients may not have previously received a vaccine against varicella or zoster.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Genovefa Papanicolaou at 212-639-8361.
Disease(s)
Blood and Marrow Transplantation: Transplantation
Locations
