Shingrix In Recipients of Allogeneic Transplants

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05775718
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bone Marrow Transplant
  • Stem Cell Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Zoster Vaccine Recombinant — DRUG
    Injection

Study Details

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.

Key Dates

Start date
Oct 24, 2023
Status verified
Feb 2026
Primary completion
Jan 20, 2028
Completion
Dec 1, 2030

Study Design

Enrollment
55 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1-<2 years post stem cell transplant
    At Visit 1 participants will be given information about the nature of HZ and its recognition and given a questionnaire for completion should they develop HZ during the study. They will also be asked to contact the study team if they develop HZ so that further evaluation of potential HZ is completed and the details of the event recorded. A swab of an active lesion or crust from a dried lesion will be obtained for VZV PCR. A participant who develops HZ will be asked to complete the questionnaire weekly for 4 weeks and then at 8 and 12 weeks. In addition, the subject will be asked about pain medications taken during the episode. Information on HZ incidence will be supplemented from the clinic medical records and the electronic medical records. Subjects will be followed for 1 year after enrollment for the occurrence of HZ and of post-herpetic neuralgia (PHN).
  • Experimental: 2-<3 years post stem cell transplant
    At Visit 1 participants will be given information about the nature of HZ and its recognition and given a questionnaire for completion should they develop HZ during the study. They will also be asked to contact the study team if they develop HZ so that further evaluation of potential HZ is completed and the details of the event recorded. A swab of an active lesion or crust from a dried lesion will be obtained for VZV PCR. A participant who develops HZ will be asked to complete the questionnaire weekly for 4 weeks and then at 8 and 12 weeks. In addition, the subject will be asked about pain medications taken during the episode. Information on HZ incidence will be supplemented from the clinic medical records and the electronic medical records. Subjects will be followed for 1 year after enrollment for the occurrence of HZ and of post-herpetic neuralgia (PHN).
  • Experimental: ≥ 3 years post stem cell transplant
    At Visit 1 participants will be given information about the nature of HZ and its recognition and given a questionnaire for completion should they develop HZ during the study. They will also be asked to contact the study team if they develop HZ so that further evaluation of potential HZ is completed and the details of the event recorded. A swab of an active lesion or crust from a dried lesion will be obtained for VZV PCR. A participant who develops HZ will be asked to complete the questionnaire weekly for 4 weeks and then at 8 and 12 weeks. In addition, the subject will be asked about pain medications taken during the episode. Information on HZ incidence will be supplemented from the clinic medical records and the electronic medical records. Subjects will be followed for 1 year after enrollment for the occurrence of HZ and of post-herpetic neuralgia (PHN).

Primary Outcome Measure

Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant [ Time Frame: 1 Year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045
Tori Rutherford, RN BSN
[email protected]
303-724-2454
Jonathan Gutman, MD (SUB_INVESTIGATOR)

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By research site
University of Colorado Hospital· Aurora, CO

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