NCT05775718 Shingrix In Recipients of Allogeneic Transplants
| NCT ID | NCT05775718 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Colorado, Denver |
| Condition | Bone Marrow Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2023-10-24 |
| Primary Completion | 2028-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 55 participants in total. It began in 2023-10-24 with a primary completion date of 2028-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Myron Levin, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT05775718 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Bone Marrow Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05775718 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05775718 currently recruiting?
Yes, NCT05775718 is actively recruiting participants. Contact the research team at tori.rutherford@childrenscolorado.org for enrollment information.
Where is the NCT05775718 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05775718 clinical trial?
NCT05775718 is sponsored by University of Colorado, Denver. The principal investigator is Myron Levin, MD at University of Colorado, Denver. The trial plans to enroll 55 participants.