Shingrix In Recipients of Allogeneic Transplants

Launched by UNIVERSITY OF COLORADO, DENVER · Mar 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the Shingrix vaccine, which is designed to protect against shingles, in people who have had a stem cell transplant. The researchers want to find out if this vaccine works well and is safe for patients who have received this type of transplant. They will also look at how much time has passed since the transplant to see if that affects the immune response to the vaccine. Additionally, they will check if giving a third dose of the vaccine can help improve the protection against shingles.

To participate in this trial, you need to be between 18 and 79 years old and have had an allogeneic stem cell transplant at least a year ago. You should have already received two doses of the Shingrix vaccine. Women who can become pregnant must also follow specific guidelines to ensure they are not pregnant during the study. If you join this study, you can expect to receive the vaccine and go through some monitoring to see how well your body responds. It’s important to note that some people may not be eligible to participate, especially if they have certain medical conditions or are on specific medications.

Gender

ALL

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