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
University of Colorado, Denver
55 participants
Oct 24, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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 Criteria8
- 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
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Interventions
Injection
Locations(1)
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NCT05775718