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New treatment option for Bone Marrow Transplant
Official title Shingrix In Recipients of Allogeneic Transplants
ClinicalTrials.gov ID: NCT05775718
What this study is testing
What is Zoster Vaccine Recombinant?
Zoster Vaccine Recombinant is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for bone marrow transplant.
Also referred to as Shingrix.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- 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 people of childbearing potential (FOCBP) enrolled in the study only if they:
You likely can't join if
- 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
See the full eligibility 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 people 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.