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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Zoster Vaccine Recombinant
DrugInjection
Treatment groups
55 Participants
are divided into 3 treatment groupsGroup A: 1-<2 years post stem cell transplantExperimental treatment 1 intervention
Group B: 2-<3 years post stem cell transplantExperimental treatment 1 intervention
Group C: ≥ 3 years post stem cell transplantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant
To compare gE-specific CMI immune response of Cohort 1 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment across 3 groups defined by the time of vaccination after transplantation.
Time frame
1 Year2
Compare the immune response via blood draw of Cohort 1 prior to enrollment to ≥1 year post-transplant to immune-competent older recipients
To compare gE-specific CMI immune response of Cohort 1 in allo-SCT who received 2 doses of Shingrix ≥1 years post-transplantation and 18-30 months prior to enrollment to immunologic data previously determined in prior studies of immune-competent older recipients of RZV (age ≥50 years).
Time frame
1 Year3
Determine adverse events after a 3rd dose of Shingrix administered 18-30 months after primary immunization for Cohort 1
Document all adverse events after 3rd dose of Shingrix.
Time frame
1 Year4
Compare gE-specific CMI via blood draw in Cohort 1 recipients at 30-60 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose
To compare gE-specific CMI in Cohort 1 recipients at 30-60 days after the 3rd dose of Shingrix with responses before the administration of the 3rd dose.
Time frame
1 YearSecondary outcomes
1
Compare gE-specific antibody responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of older immune-competent adults at 1-2 months after the administration of the primary 2-dose regimen
To compare gE-specific antibody responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months after the 3rd dose of Shingrix with responses of older immune-competent adults at 1-2 months after the administration of the primary 2-dose regimen.
Time frame
1 Year2
Compare gE-specific antibody responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of immune-competent adults at 1 year after the administration of the primary 2-dose regimen
To compare gE-specific antibody responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months and 1 year after the 3rd dose of Shingrix with responses of older immune competent adults at 1-2 months and 1 year, respectively, after administration of the primary 2-dose regimen.
Time frame
1 Year3
Compare VZV-specific IL2 responses via blood draw in allo-SCT recipients 18-30 months after primary immunization with Shingrix with responses of older immune-competent adults at 1-2 months after administration of the primary 2-dose regimen
To compare VZV-specific IL2 responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months and 1 year after the 3rd dose of Shingrix with responses of older immune-competent adults at 1-2 months and 1 year, respectively, after administration of the primary 2-dose regimen.
Time frame
1 Year4
Compare VZV-specific IL2 responses via blood draw in allo-SCT primary immunization 1-2 months after 3rd dose of Shingrix with responses of older immune-competent adults at 1-2 months after administration of primary 2-dose response.
To compare VZV-specific IL2 responses in allo-SCT recipients 18-30 months after primary immunization with Shingrix, and 1-2 months and 1 year after the 3rd dose of Shingrix with responses of older immune-competent adults at 18-30 months and 1 year, respectively, after administration of the primary 2-dose regimen.
Time frame
1 YearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov