Bone Marrow TransplantPhase 2AlloNCT05775718
Shingrix In Recipients of Allogeneic Transplants
A Phase 2 study testing Zoster Vaccine Recombinant in people with Bone Marrow Transplant and Stem Cell Transplant, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Bone Marrow Transplant, Stem Cell Transplant
- What is being tested?
- Zoster Vaccine Recombinant
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2023to 1 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Tori Rutherford, RN BSN, 303-724-2454, tori.rutherford@childrenscolorado.org
Jonathan Gutman, MD
About this study
Official title: Safety and Immunogenicity of Shingrix Administered to Recipients of Allogeneic Peripheral and Cord Blood Stem Cell Transplants: Effect of Timing of Vaccination After Transplantation
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.
Read the detailed description
This is a phase II, single center, prospective, unblinded, immunogenicity and safety study. It is anticipated that enrollment will take approximately 12 months. Duration of participation for study subjects is approximately 1 year. During this interval, participants will continue to receive clinical care from the BMT center, which will ensure retention.
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
- Bone Marrow Transplant, Stem Cell Transplant
- Being tested
- Zoster Vaccine Recombinant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoster Vaccine RecombinantDrug
Also called Shingrix
Injection
| Study group | Role | What they receive |
|---|---|---|
| 1-<2 years post stem cell transplant | Experimental | 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). Receives: Drug: Zoster Vaccine Recombinant |
| 2-<3 years post stem cell transplant | Experimental | 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). Receives: Drug: Zoster Vaccine Recombinant |
| ≥ 3 years post stem cell transplant | Experimental | 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). Receives: Drug: Zoster Vaccine Recombinant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant
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.
Measured: 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
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).
Measured: 1 Year
Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 1
Document all adverse events after 3rd dose of Shingrix.
Measured: 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
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.
Measured: 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
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.
Measured: 1 Year
Compare the immune response via blood draw of Cohort 2 prior to enrollment to ≥1 year post-transplant
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.
Measured: 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
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).
Measured: 1 Year
Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 2
Document all adverse events after 3rd dose of Shingrix.
Measured: 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
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.
Measured: 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
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.
Measured: 1 Year
Compare the immune response via blood draw of Cohort 3 prior to enrollment to ≥1 year post-transplant
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.
Measured: 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
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).
Measured: 1 Year
Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 3
Document all adverse events after 3rd dose of Shingrix.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 1 Year
Secondary outcomes (12)
Compare gE-specific antibody responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of older immune-competent adults at 1-2 months after the administration of the primary 2-dose regimen
To compare gE-specific antibody responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months after the 3rd dose of Shingrix with responses of older immune-competent adults at 1-2 months after the administration of the primary 2-dose regimen.
Measured: 1 Year
Compare gE-specific antibody responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of immune-competent adults at 1 year after the administration of the primary 2-dose regimen
To compare gE-specific antibody responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months and 1 year after the 3rd dose of Shingrix with responses of older immune competent adults at 1-2 months and 1 year, respectively, after administration of the primary 2-dose regimen.
Measured: 1 Year
Compare VZV-specific IL2 responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of older immune-competent adults at 1-2 months after administration of the primary 2-dose regimen
To compare VZV-specific IL2 responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months and 1 year after the 3rd dose of Shingrix with responses of older immune-competent adults at 1-2 months and 1 year, respectively, after administration of the primary 2-dose regimen.
Measured: 1 Year
Compare VZV-specific IL2 responses via blood draw in allo-SCT primary immunization 1-2 months after 3rd dose of Shingrix with responses of older immune-competent adults at 1-2 months after administration of primary 2-dose response.
To compare VZV-specific IL2 responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months and 1 year after the 3rd dose of Shingrix with responses of older immune-competent adults at 18-30 months and 1 year, respectively, after administration of the primary 2-dose regimen.
Measured: 1 Year
Compare VZV-specific IL2 responses via blood draw in allo-SCT recipients 1 year after the 3rd dose of Shingrix with responses of older immune-competent adults at 1 year after administration of the primary 2-dose regimen.
To compare VZV-specific IL2 responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months and 1 year after the 3rd dose of Shingrix with responses of older immune-competent adults at 1-2 months and 1 year, respectively, after administration of the primary 2-dose regimen.
Measured: 1 Year
Compare the gE-specific T cell differentiation via blood draw in allo-SCT recipients before the 3rd dose of Shingrix to imune-competent adults
To compare the gE-specific T cell differentiation in allo-SCT recipients before the 3rd dose of Shingrix with the immune profiles of immune-competent older adults before primary immunization regimen.
Measured: 1 Year
Compare the gE-specific T cell differentiation via blood draw in allo-SCT recipients after the 3rd dose of Shingrix to immune-competent adults
To compare the gE-specific T cell differentiation in allo-SCT recipients after the 3rd dose of Shingrix with the immune profiles of immune-competent older adults after the primary immunization regimen.
Measured: 1 Year
Compare the gE-specific trained immunity profiles via blood draw in allo-SCT recipients before the 3rd dose of Shingrix with the profile of immune-competent adults
To compare the gE-specific trained immunity profiles in allo-SCT recipients before the 3rd dose of Shingrix with the immune profiles of immune-competent older adults before the primary immunization regimen.
Measured: 1 year
Compare the gE-specific trained immunity profiles via blood draw in allo-SCT recipients after the 3rd dose of Shingrix with the profiles of immune-competent adults
To compare the gE-specific trained immunity profiles in allo-SCT recipients after the 3rd dose of Shingrix with the immune profiles of immune-competent older adults after the primary immunization regimen.
Measured: 1 year
Determine the incidence of HZ in allo-SCT recipients who received 3 doses of Shingrix.
To assess the incidence of HZ in allo-SCT recipients who received 3 doses of Shingrix post-Tx as reported by patients.
Measured: 1 year
Determine the severity of HZ via blood draw and patient dairy in allo-SCT recipients who received 3 doses of Shingrix.
To assess the incidence and severity of HZ in allo-SCT recipients who received 3 doses of Shingrix post-Tx as reported by patients.
Measured: 1 year
Determine the predictive value of TTV titer via blood draw on the immunogenicity of the 3rd dose of Shingrix in allo-SCT
To assess the value of TTV titer on the immunogenicity in allo-SCT recipients who received 3 doses of Shingrix post-Tx as reported by patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start24 Oct 2023
- Primary completion20 Jan 2028 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow TransplantStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Myron Levin, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775718
- Sponsor's protocol ID
- 22-0394.cc
- Other IDs
- NCI-2023-04097
- Acronym
- Allo
- Status last verified
- Oct 2026
- First submitted
- 28 Feb 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Shingrix Administered to Recipients of Allogeneic Peripheral and Cord Blood Stem Cell Transplants: Effect of Timing of Vaccination After Transplantation
- ClinicalTrials.gov ID
- NCT05775718
- Acronym / sponsor ID
- Allo / 22-0394.cc
- Conditions
- Bone Marrow Transplant, Stem Cell Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 20 Jan 2028 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase II, single center, prospective, unblinded, immunogenicity and safety study. It is anticipated that enrollment will take approximately 12 months. Duration of participation for study subjects is approximately 1 year. During this interval, participants will continue to receive clinical care from the BMT center, which will ensure retention.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-<2 years post stem cell transplant | Experimental | Drug: Zoster Vaccine RecombinantAt 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). |
| 2-<3 years post stem cell transplant | Experimental | Drug: Zoster Vaccine RecombinantAt 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). |
| ≥ 3 years post stem cell transplant | Experimental | Drug: Zoster Vaccine RecombinantAt 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). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoster Vaccine RecombinantAlso: ShingrixInjection | Drug | 1-<2 years post stem cell transplant, 2-<3 years post stem cell transplant, ≥ 3 years post stem cell transplant |
Primary outcome
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.
12 secondary outcomes
Compare gE-specific antibody responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of older immune-competent adults at 1-2 months after the administration of the primary 2-dose regimen
Time frame: 1 Year
Compare gE-specific antibody responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of immune-competent adults at 1 year after the administration of the primary 2-dose regimen
Time frame: 1 Year
Compare VZV-specific IL2 responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of older immune-competent adults at 1-2 months after administration of the primary 2-dose regimen
Time frame: 1 Year
Compare VZV-specific IL2 responses via blood draw in allo-SCT primary immunization 1-2 months after 3rd dose of Shingrix with responses of older immune-competent adults at 1-2 months after administration of primary 2-dose response.
Time frame: 1 Year
Compare VZV-specific IL2 responses via blood draw in allo-SCT recipients 1 year after the 3rd dose of Shingrix with responses of older immune-competent adults at 1 year after administration of the primary 2-dose regimen.
Time frame: 1 Year
Compare the gE-specific T cell differentiation via blood draw in allo-SCT recipients before the 3rd dose of Shingrix to imune-competent adults
Time frame: 1 Year
Compare the gE-specific T cell differentiation via blood draw in allo-SCT recipients after the 3rd dose of Shingrix to immune-competent adults
Time frame: 1 Year
Compare the gE-specific trained immunity profiles via blood draw in allo-SCT recipients before the 3rd dose of Shingrix with the profile of immune-competent adults
Time frame: 1 year
Compare the gE-specific trained immunity profiles via blood draw in allo-SCT recipients after the 3rd dose of Shingrix with the profiles of immune-competent adults
Time frame: 1 year
Determine the incidence of HZ in allo-SCT recipients who received 3 doses of Shingrix.
Time frame: 1 year
Determine the severity of HZ via blood draw and patient dairy in allo-SCT recipients who received 3 doses of Shingrix.
Time frame: 1 year
Determine the predictive value of TTV titer via blood draw on the immunogenicity of the 3rd dose of Shingrix in allo-SCT
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Myron Levin, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoster Vaccine Recombinant in people with Bone Marrow Transplant and Stem Cell Transplant, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tori Rutherford, RN BSN (303-724-2454, tori.rutherford@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.