Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of Wisconsin, Madison
With
Study Visits: * Visit 1 (V1) - day 1 - blood draw, RZV dose 1 * Follow up (FU) 1 - between days 7-15 * FU 2 - between days 22-29 * Visit 2 (V2) - between days 30-90 - RZV dose 2 * FU 3 - V2 + 7-14 days * Visit 3 (V3) - V2 + 21-50 days - blood draw * Visit 4 (V4) - V2 + approximately 360 days - blood draw Primary Objective: • To demonstrate a 10% higher humoral immunogenicity following two doses of RZV in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy. Secondary Objectives: * To evaluate the vaccine response rate (VRR) for anti-glycoprotein E (gE) humoral immune responses in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy. * To characterize the anti-gE humoral immunogenicity at visit 1 (V1), visit 3 (V3), and visit 4 (V4) in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy. * To evaluate the safety and reactogenicity following administration of RZV, up to 30 days post-last vaccination and during the entire post-vaccination follow-up period. * To evaluate IBD activity following administration of RZV, up to 30 days post-last vaccination and during the entire post-vaccination follow-up period. Tertiary/Exploratory Objectives: * To characterize gE-specific CD4+ T-cell mediated immune responses in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy. * To characterize gE-specific CD4+ T-cell mediated immune responses in patients on JAKs. * To evaluate the VRR for anti-gE humoral immune responses in patients on Janus Kinase inhibitors (JAKs). * To characterize the anti-gE humoral immunogenicity at V1, V3, and V4 in patients on JAKs. * To determine the relationship between gut microbiota and response to RZV series.
Age
19–85
Sex
ALL
Healthy volunteers
Not accepted
