Shingrix In Recipients of Allogeneic Transplants
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorUniversity of Colorado, Denver
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Zoster Vaccine Recombinant
Treatment groups
55 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov