NCT05775718 · University of Colorado, Denver
Shingrix In Recipients of Allogeneic Transplants
(Allo)
What this study is about
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).
View original scientific 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.
Interventions
DRUG
Zoster Vaccine Recombinant
Injection
Primary outcome measures
Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant
Time frame: 1 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 recipients
Time frame: 1 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 1
Time frame: 1 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 dose
Time frame: 1 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 dose
Time frame: 1 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-transplant
Time frame: 1 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 recipients
Time frame: 1 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 2
Time frame: 1 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 dose
Time frame: 1 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 dose
Time frame: 1 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-transplant
Time frame: 1 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 recipients
Time frame: 1 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 3
Time frame: 1 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 dose
Time frame: 1 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 dose
Time frame: 1 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 Shingrix
Time frame: 1 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 Shingrix
Time frame: 1 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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
Where
- Aurora, Colorado
Collaborators
GlaxoSmithKline
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations