Shingrix In Recipients of Allogeneic Transplants

• Status: Not yet recruiting
• Trial end date: 2030-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: GlaxoSmithKline

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 18-30 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