Shingrix in Recipients of Allogeneic Transplants

Description

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.

Conditions

Bone Marrow Transplant, Stem Cell Transplant

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Study Overview

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Study Details

Study overview

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.

Safety and Immunogenicity of Shingrix Administered to Recipients of Allogeneic Peripheral and Cord Blood Stem Cell Transplants: Effect of Timing of Vaccination After Transplantation

Shingrix in Recipients of Allogeneic Transplants

Condition
Bone Marrow Transplant
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Hospital, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 79 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Myron Levin, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

2030-12-01