A Phase I/IIa Randomized, Observer-Blind, Placebo-Controlled, Multicenter Study to evaluate the Safety and Immunogenicity of the GSK Biologicals’ Herpes Zoster Vaccine, gE/AS01B, in comparison to gE combined with 1/2 Dose AS01B adjuvant (gE/AS01E) and to Saline (placebo) when Administered as 2 Doses or 3 Doses to Autologous Hematopoietic Stem Cell Transplantation (HCT) Recipients.
|PI:||Frits van Rhee, MD, PhD|
To evaluate the safety and reactogenicity of the gE/AS01B and gE/AS01E study vaccines in adult autologous HCT recipients; To compare gE-specific humoral and cellular immune responses at Month 4 (one month post-final vaccination) between subjects who received three doses of gE/AS01B vaccine (Months 0, 1 and 3), subjects who received three doses of gE/AS01E vaccine (Months 0, 1 and 3), subjects who received two doses of gE/AS01B vaccine (Months 1 and 3) and subjects who received placebo.
|Eligibility:||To be eligible for this study you must have undergone autologous HCT within the past 50-70 days for treatment of Hodgkin lymphoma, non- Hodgkin lymphoma (T or B cell), myeloma or AML, and there are no plans for additional HCTs (tandem autologous HCT recipients may participate following their final HCT.
A total of 120 adults (30 subjects randomized to the gE/AS01B 3-dose group; 30 subjects randomized to the gE/AS01E 3-dose group; 30 subjects randomized to the gE/AS01B 2-dose group and 30 subjects randomized to the Placebo group) are planned to be enrolled.
|Treatment:||If you agree to take part in this research study, you must sign this informed consent form sheet before any study-related tests or procedures may be performed.
If you meet the requirements for the study, you will be in the study for approximately 15 months or 64 weeks from your first visit. The study will include 6 visits to the study center.
At Visit 1, the staff at the study center will ask you questions about your medical history and any medications that you may have been taking to determine if you can participate in this study.
501-526-6990 ext. 2435