Phase 2Recruiting
Shingrix In Recipients of Allogeneic Transplants
Safety and Immunogenicity of Shingrix Administered to Recipients of Allogeneic Peripheral and Cord Blood Stem Cell Transplants: Effect of Timing of Vaccination After Transplantation
- Sponsor
- University of Colorado, Denver (Academic or other)
- Enrolment
- 55 planned
- Conditions
- Bone Marrow Transplant; Stem Cell Transplant
- Interventions
- Zoster Vaccine Recombinant
- Ages
- adults, older adults
- Registry
- NCT05775718
From the registry
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.
Primary outcomes
- Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant
- Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant to immune-competent older recipients
- Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 1
- 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