Recruiting
Phase 2

Shingrix

Sponsor:

University of Colorado, Denver

Code:

NCT05775718

Conditions

Bone Marrow Transplant

Stem Cell Transplant

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Zoster Vaccine Recombinant

Study Details

Brief 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). 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.

Conditions

Bone Marrow Transplant

Stem Cell Transplant

Study ID

NCT05775718

Start date

Oct 24, 2023

Status verified date

Feb, 2026

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Jan 20, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

55 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

experimental: 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).

experimental: ≥ 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).

Interventions

Zoster Vaccine Recombinant

Injection

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 ]
  • 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 ]
  • Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 1 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 Year ]
  • Compare the immune response via blood draw of Cohort 2 prior to enrollment to ≥1 year post-transplant [ Time Frame: 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 [ Time Frame: 1 Year ]
  • Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 2 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 Year ]
  • Compare the immune response via blood draw of Cohort 3 prior to enrollment to ≥1 year post-transplant [ Time Frame: 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 [ Time Frame: 1 Year ]
  • Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 3 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Tori Rutherford, RN BSN

303-724-2454tori.rutherford@childrenscolorado.org

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Tori Rutherford, RN BSN

303-724-2454tori.rutherford@childrenscolorado.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-02-05.