Shingrix In Recipients of Allogeneic Transplants

Recruiting now · Phase 2

Conditions studied: Bone Marrow Transplant, Stem Cell Transplant

In brief

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.

Key facts

Study ID

NCT05775718

Run by

University of Colorado, Denver

People needed

55

Starts

2023-10-24

Expected to finish

2030-12-01

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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