Evaluating Shingrix Vaccine in Stem Cell Transplant Recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improving outcomes for stem cell transplant patients using an intervention website

  This study is testing if a special website can help adults with blood cancer feel better and improve their quality of life after a stem cell transplant compared to a regular educational website.

  Recruiting at 3 sites Northwestern University · Washington D.C., District of Columbia and 2 other locations · NCT06960993

• Venetoclax added to reduced-intensity conditioning for combined stem cell and kidney transplant

  This trial tests whether adding venetoclax to a reduced-intensity conditioning regimen is safe for adults with blood cancers who are receiving a combined stem cell and kidney transplant from a matched or partially matched donor.

  Recruiting Early Phase 1 Massachusetts General Hospital · Boston, Massachusetts · NCT07358195

• Optimizing and Unifying Management of HSCT in Pediatric ALL

  This trial tests a harmonized HSCT approach for children and young people with ALL, aiming to reduce transplant-related risks and improve long-term outcomes.

  Recruiting at 2 sites Phase 2/3 Bambino Gesù Hospital and Research Institute · Vienna and 8 other locations · NCT07297914

• Psychosocial and behavioral support for stem cell transplant patients and their family caregivers

  This project tests two brief four-session video counseling programs to help stem cell transplant patients and their family caregivers manage care and stick to medical instructions after hospital discharge.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07107165

• Cardiovascular health in children and young adults with chronic conditions

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  Recruiting Semmelweis University · Budapest and 2 other locations · NCT07086989

• Protecting fertility in young cancer patients

  This study is trying to find ways to help young cancer patients keep their ability to have children after treatment by looking at what might affect their fertility.

  Recruiting University of Ulm · Ulm, Baden-Wurttemberg · NCT06692868

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.