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)

ID Number 11-0429

Principal Investigator(s)
Luis M Isola

Department(s) or Division(s)
Hematology and Medical Oncology

Description

The purpose of this study is to:

  • Test the safety and tolerability (how well you can endure the side effects) of the research study vaccine, V212, in the prevention of shingles in subjects receiving an autologous bone marrow (you receive your own bone marrow) or stem cell transplant (you receive your own stem cells)
  • Compare the effectiveness of the research study vaccine, V212, in the prevention of shingles in subjects receiving an autologous bone marrow or stem cell transplant to placebo (a shot with no active ingredients)
  • See how well the study vaccine works in subjects with a decreased ability to fight infection who are receiving an autologous bone marrow or stem cell transplant.

This is a research study to test an investigational vaccine that has not been approved for sale.  The study vaccine (V212) is varicella-zoster virus (VZV) vaccine that is inactivated by irradiation.  The vaccine is irradiated to kill the vaccine virus. The inactivated VZV vaccine is made with the same weakened virus as Merck’s chicken pox and shingles vaccines; however, the inactivated VZV vaccine is made with one additional step that stops the virus's ability to spread. It is possible that a very small number of virus particles may still be able to spread, and the inactivated VZV vaccine may contain a little bit of live vaccine virus.  To make it easy to remember, we will call it the study vaccine.

You may qualify to take part in this research study because you have a prior history of varicella (chicken pox) and you are scheduled to have an autologous bone marrow or stem cell transplant.



Contact Information
Zachary Galitzeck
(212) 241-6377


Recruiting Patients: No