Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
55 participants
INTERVENTIONAL
2023-10-24
2030-12-01
Brief Summary
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Detailed Description
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Participants will be recruited at their routine clinic visits, which take place every 6 months post-transplantation, or will be recruited by phone. Participants will be consented by study personnel in coordination with the BMT health care providers and subsequently followed in Dr. Levin's Vaccine Research Clinic, where they will also receive the 3rd dose of vaccine.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
Zoster Vaccine Recombinant
Injection
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).
Zoster Vaccine Recombinant
Injection
≥ 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).
Zoster Vaccine Recombinant
Injection
Interventions
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Zoster Vaccine Recombinant
Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
79 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Myron Levin, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Hospital
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2023-04097
Identifier Type: OTHER
Identifier Source: secondary_id
22-0394.cc
Identifier Type: -
Identifier Source: org_study_id
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