Evaluating Shingrix Vaccine in Stem Cell Transplant Recipients
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 study tests if the Shingrix vaccine is safe and effective for people who have had a stem cell transplant, and looks at how the timing of the vaccine affects their immune response.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05775718 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to assess the immunogenicity and safety of the Shingrix vaccine in individuals who have undergone allogeneic stem cell transplants. The study will investigate how the timing of vaccination after transplantation affects immune responses and whether an additional vaccine dose is necessary to enhance these responses. Participants will be recruited during routine clinic visits or by phone, and they will receive clinical care throughout the study duration of approximately one year.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 79 who have received an allogeneic stem cell transplant and have previously received two doses of the Shingrix vaccine.
Not a fit: Patients with active graft versus host disease or those who have been on high-dose prednisone for an extended period may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve vaccination strategies for stem cell transplant recipients, enhancing their protection against herpes zoster.
How similar studies have performed: While there is limited data on the specific use of Shingrix in this population, similar studies have shown promising results in improving vaccine responses in immunocompromised patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Colorado Hospital — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Myron Levin, MD — University of Colorado, Denver
- Study coordinator: Tori Rutherford, RN BSN
- Email: tori.rutherford@childrenscolorado.org
- Phone: 303-724-2454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.