Clinical trial

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

Name

22-0394.cc

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.

Trial arms

Trial start

2024-12-01

Estimated PCD

2025-05-01

Trial end

2030-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Zoster Vaccine Recombinant

Injection

Arms:

1-<2 years post stem cell transplant, 2-<3 years post stem cell transplant, ≥ 3 years post stem cell transplant

Other names:

Shingrix

Size

Primary endpoint

Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant

1 Year

Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant to immune-competent older recipients

1 Year

Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 1

1 Year

Compare gE-specific CMI via blood draw in Cohort 1 recipients at 30-60 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose

1 Year

Compare gE-specific CMI via blood draw in Cohort 1 recipients at 365 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose

1 Year

Compare the immune response via blood draw of Cohort 2 prior to enrollment to ≥1 year post-transplant

1 Year

Compare the immune response via blood draw of Cohort 2 prior to enrollment to ≥1 year post-transplant to immune-competent older recipients

1 Year

Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 2

1 Year

Compare gE-specific CMI via blood draw in Cohort 2 recipients at 30-60 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose

1 Year

Compare gE-specific CMI via blood draw in Cohort 2 recipients at 365 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose

1 Year

Compare the immune response via blood draw of Cohort 3 prior to enrollment to ≥1 year post-transplant

1 Year

Compare the immune response via blood draw of Cohort 3 prior to enrollment to ≥1 year post-transplant to immune-competent older recipients

1 Year

Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 3

1 Year

Compare gE-specific CMI via blood draw in Cohort 3 recipients at 30-60 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose

1 Year

Compare gE-specific CMI via blood draw in Cohort 3 recipients at 365 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose

1 Year

Compare gE-specific CMI via blood draw at 30-60 days after a 3rd dose of Shingrix in allo-SCT with responses of immune-competent older adults at the same time point after the dose of Shingrix

1 Year

Compare gE-specific CMI via blood draw at 365 days after a 3rd dose of Shingrix in allo-SCT with responses of immune-competent older adults at the same time points after the 2nd dose of Shingrix

1 Year

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 18-30 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 55, 'type': 'ESTIMATED'}}

Updated at

2024-02-05

1 organization

1 product

2 indications

Organization

University of Colorado Denver

Product

Zoster Vaccine Recombinant

Indication

Bone Marrow Transplant

Indication

Stem Cell Transplant