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NCT05775718
Shingrix In Recipients of Allogeneic Transplants
Conditions: Bone Marrow Transplant, Stem Cell Transplant
Sex: All
Ages: 18 Years – 79 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 55
Sponsor: University of Colorado, Denver
Location: University of Colorado Hospital Aurora Colorado
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 Criteria
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
Source: ClinicalTrials.gov (NCT05775718). StuddyBuddy aggregates publicly available trial information.