This phase II clinical trial tests the safety and effectiveness of giving a third dose of zoster vaccine recombinant, adjuvanted (Shingrix) for improving immunity against shingles in patients who have received allogeneic stem cell transplants. Shingles, also known as herpes zoster, is a disease caused by the virus that causes chickenpox. After having chickenpox in childhood, the virus remains hidden in the body. Immunity to the chickenpox virus normally keeps the virus from causing further disease in the form of shingles. However, when this immunity fails, as sometimes happens with allogeneic stem cell transplants, shingles can occur. Shingrix is a vaccine which may protect patients who have received allogeneic stem cell transplants from developing shingles by helping the body make stronger defenses against infection. The Shingrix vaccine is approved by the Food and Drug Administration for use in preventing shingles, but the administration of a third dose is investigational. Adding a third dose of the Shingrix vaccine may improve immune response and protection in patients who have undergone an allogeneic stem cell transplant.
Additional locations may be listed on ClinicalTrials.gov for NCT05775718.
Locations matching your search criteria
United States
Colorado
Aurora
UCHealth University of Colorado HospitalStatus: Active
Contact: Myron J. Levin
Phone: 303-724-2451
Denver
University of ColoradoStatus: Active
Contact: Myron J. Levin
Phone: 720-777-1234
PRIMARY OBJECTIVES:
I. To compare glycoprotein E (gE)-specific cell-mediated immune (CMI) immune responses in allogeneic stem cell transplant (allo-SCT) who received 2 doses of zoster vaccine recombinant, adjuvanted (Shingrix) >= 1 years post-transplantation and ≥ 18 months prior to enrollment across 3 groups defined by the time of vaccination after transplantation.
II. To compare gE-specific CMI in each group of allo-SCT defined by the time of vaccination after transplantation (1-< 2; 2-< 3; >= 3 years) with responses of immune-competent older adults ≥ 18 months post-vaccination.
III. To determine adverse events after a 3rd dose of Shingrix administered ≥ 18 months after primary immunization to allo-SCT recipients.
IV. To compare gE-specific CMI in allo-SCT recipients at 30-60 days and 365 days after the 3rd dose of Shingrix administered ≥ 18 months after the primary immunization with responses before the administration of the 3rd dose.
V. To compare gE-specific CMI at 30-60 days and 365 days after a 3rd dose of Shingrix in allo-SCT with responses of immune competent older adults at the same time points after the 2nd dose of Shingrix.
SECONDARY OBJECTIVES:
I. To compare gE-specific antibody responses in allo-SCT recipients ≥ 18 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.
II. To compare varicella-zoster virus (VZV)-specific interleukin (IL) 2 responses in allo-SCT recipients ≥ 18 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.
III. To compare the gE-specific T cell differentiation and trained immunity profiles in allo-SCT recipients before and after the 3rd dose of Shingrix with the immune profiles of immune competent older adults before and after the primary immunization regimen.
IV. To assess the incidence and severity of herpes zoster (HZ) in allo-SCT recipients who received 3 doses of Shingrix post-treatment (Tx).
V. To determine the predictive value of Torque teno virus (TTV) titer on the immunogenicity of the 3rd dose of Shingrix in allo-SCT.
OUTLINE:
Patients receive the Shingrix vaccine intramuscularly (IM) on day 0. Patients also undergo blood sample collection between days 30-60 and at 1 year.
After completion of study treatment, patients follow up at 30-60 days and 1 year.
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorMyron J. Levin
