Shingrix In Recipients of Allogeneic Transplants

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.

This is a phase II, single center, prospective, unblinded, immunogenicity and safety study. It is anticipated that enrollment will take approximately 6 months. Duration of participation for study subjects is approximately 1 year. During this interval, participants will continue to receive clinical care from the BMT center, which will ensure retention.

Participants will be recruited at their routine clinic visits, which take place every 6 months post-transplantation, or will be recruited by phone. Participants will be consented by study personnel in coordination with the BMT health care providers and subsequently followed in Dr. Levin's Vaccine Research Clinic, where they will also receive the 3rd dose of vaccine.

Inclusion Criteria:

• 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

Exclusion Criteria:

• Active Graft Versus Host Disease (aGVHD) at the time of enrollment and receipt of the third dose of RZV
• Having received ≥20 mg prednisone for more than 2 weeks (or equivalent) in the 8 weeks preceding enrollment.
• Receiving any significant immunosuppressive therapy other than for graft maintenance, in the opinion of the investigator.
• Having received a live attenuated vaccine within the last 4 weeks, or inactivated vaccine in the last 2 weeks, prior to enrollment.
• Having a history of HZ after the administration of the primary 2-dose RZV immunization regimen.
• Pregnancy or breastfeeding
• Receiving investigational drugs from 30 day before enrollment or planned during the study
• Inability of participants unable to comply with the study schedule in the opinion of the investigator