This multi-center study will evaluate the safety and immune response to recombinant zoster vaccine (RZV) series in 264 patients with inflammatory bowel disease (IBD) on immunosuppressive therapy recruited from 6 study sites who can expect to be on study for up to 14 months.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The RZV vaccine is indicated for prevention of herpes zoster (HZ) in adults aged 18 years and older who are or will be at increased risk of HZ. Patients with IBD on immunosuppressive therapy are at increased risk for HZ.
Mayo Clinic
Jacksonville, Florida, United States
Mercy Medical Center
Baltimore, Maryland, United States
New York University
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Geometric Mean Concentrations of Anti-gE Antibodies
Anti-gE antibody concentrations expressed as geometric mean concentrations (GMCs) at V3, following 2 doses of RZV, in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
Time frame: Visit 3 (between 50 and 140 days on study)
Vaccine response rate (VRR)
Vaccine response rate (VRR) with exact 95% confidence intervals at V3 in those on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
Time frame: Visit 3 (between 50 and 140 days on study)
Seropositivity rate
Seropositivity rate with exact 95% confidence interval (CI) at V1, V3, and V4 in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
Time frame: Visit 1 (day 1), Visit 3 (between 50 and 140 days on study), Visit 4 (approximately 360 days)
Geometric Mean Concentrations of Anti-gE Antibodies
Anti-gE antibody concentrations expressed as GMC with 95% CI at V1, V3, and V4 in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
Time frame: Visit 1 (day 1), Visit 3 (between 50 and 140 days on study), Visit 4 (approximately 360 days)
Number of Participants with Solicited Adverse Events (AEs)
Number and percentage of patients reporting each solicited local AE and each solicited systemic AE within 7 days (Days 1-7) after each dose and overall for all study groups. Solicited local AEs are: injection site pain, redness, swelling. Solicited systemic AEs are: fatigue, myalgia, arthralgia, headache, shivering/chills, fever and gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain).
Time frame: Up to 7 days after Visit 1, up to 7 days after Visit 2
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Vanderbilt University
Nashville, Tennessee, United States
UW Hospital and Clinics
Madison, Wisconsin, United States
Number of Participants with Unsolicited Adverse Events
Number and percentage of patients reporting unsolicited AEs within 30 days (Days 1-30) after each dose and overall, for all study groups.
Time frame: up to 30 days after Visit 1, up to 30 days after Visit 2
Number of Participants Reporting Potential Immune-Mediated Diseases (pIMDs)
Number and percentage of patients reporting pIMDs from first vaccination up to study end for all study groups.
Time frame: up to 14 months
Number of Participants with Serious Adverse Events (SAEs)
Number and percentage of patients reporting SAEs and fatal SAEs from first vaccination up to study end for all study groups.
Time frame: up to 14 months
Number of Herpes Zoster Events
Number of cases of suspected HZ from study entry to last follow up date.
Time frame: up to 14 months
Number of Participants Reporting Complications from HZ
Number and percentage of patients reporting any complications of HZ reported as AEs from study entry to last follow up date.
Time frame: up to 14 months
Number of Participants reporting disease flares of IBD
Number and percentage of patients reporting disease flares of IBD in both study groups which will be assessed by monitoring disease activity using the Short Crohn's Activity Index (SCAI) for patients with Crohn's disease or the Simple Clinical Colitis Activity Index (SCCAI) questionnaire for patients with Ulcerative colitis at the baseline visit V1, Follow up 2 (FU2), V2, V3, and V4 visit.
Time frame: baseline, Visit 1 (day 1), Follow-Up 2 (up to 29 days), Visit 2 (up to 90 days), Visit 3 (up to 140 days on study), Visit 4 (up to 360 days)