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NCT Number: NCT05775718

Shingrix In Recipients of Allogeneic Transplants

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.

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Key information

Conditions

Bone Marrow Transplant Stem Cell Transplant

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Jonathan Gutman, MD

SUB_INVESTIGATOR

Tori Rutherford, RN BSN

CONTACT

[email protected]

303-724-2454

About this study

This is a phase II, single center, prospective, unblinded, immunogenicity and safety study. It is anticipated that enrollment will take approximately 6 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoster Vaccine Recombinant

Drug

Injection

Other names: Shingrix

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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).

  13. 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.

  14. 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.

  15. 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.

  16. 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

  17. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. 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

    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.

  8. 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

    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.

  9. 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

    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.

  10. Determine the incidence of HZ in allo-SCT recipients who received 3 doses of Shingrix.

    Time frame: 1 year

    To assess the incidence of HZ in allo-SCT recipients who received 3 doses of Shingrix post-Tx as reported by patients.

  11. 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

    To assess the incidence and severity of HZ in allo-SCT recipients who received 3 doses of Shingrix post-Tx as reported by patients.

  12. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tori Rutherford, RN BSN

CONTACT

[email protected]

303-724-2454

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Acronym: Allo

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
Mar 20, 2023
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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