RECRUITING

Shingrix in Recipients of Allogeneic Transplants

Conditions

Bone Marrow Transplant Stem Cell Transplant

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-10-24

Study Completion:2030-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05775718

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.

Ages Eligible for Study:18 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Tori Rutherford, RN BSN

CONTACT

303-724-2454

tori.rutherford@childrenscolorado.org

Principal Investigator

Myron Levin, MD

PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Study Locations (Sites)

University of Colorado Hospital

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-24

Study Completion Date2030-12-01

Study Record Updates

Study Start Date2023-10-24

Study Completion Date2030-12-01

Terms related to this study

Additional Relevant MeSH Terms

Bone Marrow Transplant
Stem Cell Transplant