Safety and Immunogenicity of Shingrix Administered to Recipients of Allogeneic Peripheral and Cord Blood Stem Cell Transplants: Effect of Timing of Vaccination After Transplantation
This research is designed to determine if the adjuvanted recombinant glycoprotein E (gE) herpes zoster (HZ) vaccine (Shingrix) has acceptable immunogenicity and safety in people who have undergone allogeneic stem cell transplant (allo-SCT). Specifically, it will determine the effect of the interval after transplantation on the immune response and if an additional dose of vaccine is needed to improve the vaccine-induced responses.
• Allo-SCT recipients being age 18 - 79 years at time of allo-SCT.
• Written informed consent being obtained from the subject
• Two doses of RZV, separated by 2 to 6 months, administered at least 1 year after allo-SCT.
• Enrollment at \>/= 18 months after second dose of Shingrix.
• Female subjects of childbearing potential (FOCBP) enrolled in the study only if they:
‣ have practiced adequate contraception for 30 days prior to vaccination with any dose of zoster vaccine and
⁃ have a negative pregnancy test on the day of each dose of zoster vaccine and
⁃ agree to continue adequate contraception during the vaccination period and for 2 months after receipt of the vaccine.
• Investigator belief that the participant will comply with the requirements of the protocol