Shingrix Vaccine Study for Bone Marrow and Stem Cell Transplant Recipients
This study is looking at how well the Shingrix vaccine works and if it's safe for people who have had a bone marrow or stem cell transplant. Researchers want to see if the timing after your transplant affects your body's immune response to the vaccine. They also want to find out if an extra, third dose of Shingrix, given 18-30 months after your first two doses, can improve your protection. This study will compare your immune response before and after vaccination, and also compare it to older people who haven't had a transplant. You can join if you are 18-79 years old, had your transplant at least a year ago, and have already received two doses of Shingrix.
- Study design
- This is a Phase 2, single-center study that is not blinded, meaning everyone knows what treatment is being given. It plans to enroll 55 participants.
- What's involved
- You will participate for approximately one year. During this time, you will continue your routine clinic visits and receive a third dose of the vaccine.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your immune response will be measured at one year after vaccination, and adverse events will be monitored for one year after the third dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Shingrix In Recipients of Allogeneic Transplants
At a glance
Conditions
NCT05775718
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Colorado Hospital
Aurora, Coloradostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Myron Levin, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant1 Year
To compare gE-specific CMI immune response of Cohort 1 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment across 3 groups defined by the time of vaccination after transplantation.
- Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant to immune-competent older recipients1 Year
To compare gE-specific CMI immune response of Cohort 1 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment to immunologic data previously determined in prior studies of immune-competent older recipients of RZV (age ≥50 years).
- Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 11 Year
Document all adverse events after 3rd dose of Shingrix.
- 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 dose1 Year
To compare gE-specific CMI in Cohort 1 recipients at 30-60 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose.
- 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 dose1 Year
To compare gE-specific CMI in Cohort 1 recipients at 365 days after the 3rd dose of Shingrix administered 18-30 months after the primary immunization with responses before the administration of the 3rd dose.
- Compare the immune response via blood draw of Cohort 2 prior to enrollment to ≥1 year post-transplant1 Year
To compare gE-specific CMI immune response of Cohort 2 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment across 3 groups defined by the time of vaccination after transplantation.
- Compare the immune response via blood draw of Cohort 2 prior to enrollment to ≥1 year post-transplant to immune-competent older recipients1 Year
To compare gE-specific CMI immune response of Cohort 1 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment to immunologic data previously determined in prior studies of immune-competent older recipients of RZV (age ≥50 years).
- Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 21 Year
Document all adverse events after 3rd dose of Shingrix.
- 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 dose1 Year
To compare gE-specific CMI in Cohort 2 recipients at 30-60 days after the 3rd dose of Shingrix administered 18-30 months after the primary immunization with responses before the administration of the 3rd dose.
- 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 dose1 Year
To compare gE-specific CMI in Cohort 2 recipients at 365 days after the 3rd dose of Shingrix administered 18-30 months after the primary immunization with responses before the administration of the 3rd dose.
- Compare the immune response via blood draw of Cohort 3 prior to enrollment to ≥1 year post-transplant1 Year
To compare gE-specific CMI immune response of Cohort 3 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment across 3 groups defined by the time of vaccination after transplantation.
- Compare the immune response via blood draw of Cohort 3 prior to enrollment to ≥1 year post-transplant to immune-competent older recipients1 Year
To compare gE-specific CMI immune response of Cohort 3 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment to immunologic data previously determined in prior studies of immune-competent older recipients of RZV (age ≥50 years).
- Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 31 Year
Document all adverse events after 3rd dose of Shingrix.
- 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 dose1 Year
To compare gE-specific CMI in Cohort 3 recipients at 30-60 days after the 3rd dose of Shingrix administered 18-30 months after the primary immunization with responses before the administration of the 3rd dose.
- 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 dose1 Year
To compare gE-specific CMI in Cohort 3 recipients at 365 days after the 3rd dose of Shingrix administered 18-30 months after the primary immunization with responses before the administration of the 3rd dose.
- 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 Shingrix1 Year
To compare gE-specific CMI 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
- 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 Shingrix1 Year
To compare gE-specific CMI 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.