A Phase II Study Assessing the Effectiveness of a New Vaccine for Preventing Shingles in Patients Who Had an Autologous Stem Cell Transplant

Protocol
13-054
Full Title
A Phase III, Randomized, Observer-blind, Placebo Controlled, Multicenter Clinical Trial to Assess the Prophylactic Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster (gE/AS01B) Vaccine when Administered Intramuscularly on a Two Dose Schedule to Adult Autologous Hematopoietic Stem Cell Transplant (HCT) Recipients
Phase
III
Purpose

With an autologous stem cell transplant (ASCT), some of a patient’s stem cells are removed before chemotherapy and then returned to the patient to help re-establish the patient’s immune system. However, patients who undergo this procedure have a weakened immune system, and may be more susceptible to infections such as shingles (which is caused by the herpes zoster virus). Shingles causes a rash and can produce very uncomfortable nerve pain.

The purpose of this study is to see if giving a new type of shingles vaccine to patients who have had an ASCT is effective for preventing shingles infection. The vaccine being evaluated in this study is designed to stimulate immunity against the herpes zoster virus. Patients in this study will be randomly assigned to receive two injections of the shingles vaccine or a placebo (injections of saline, a mild salt water solution).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients should have undergone or be planning to have an ASCT within 50 to 70 days of receiving the first study injection.
  • Patients may not have received a vaccination for herpes zoster or varicella within one year of receiving he first study injection.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Genovefa Papanicolaou at 212-639-8361.

Disease(s)
Blood & Marrow Stem Cell Transplantation: Autologous
Blood & Marrow Stem Cell Transplantation: Post-Transplant
Locations