Study of Response to Zoster Vaccine in Adults with Inflammatory Bowel Disease Treated with Medications

NCT06224270 | Withdrawn Phase 4 FDA Drug

• 3 other identifiers: 2023-1727A534250Protocol Version 6/14/2024
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; IBD

Keywords

immunosuppressed; Recombinant Zoster Vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  Visit 3 (between 50 and 140 days on study)

Secondary Outcomes (10)

• Vaccine response rate (VRR)

  Visit 3 (between 50 and 140 days on study)

• Seropositivity rate

  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

  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)

  Up to 7 days after Visit 1, up to 7 days after Visit 2

• Number of Participants with Unsolicited Adverse Events

  up to 30 days after Visit 1, up to 30 days after Visit 2

Other Outcomes (5)

• Number of gE-specific CD4 cells expressing at least 2 activation markers

  Visit 1 (day 1), Visit 3 (up to 140 days on study), Visit 4 (up to 360 days)

• Vaccine response rate (VRR) in patients on JAKs

  Visit 3 (up to 140 days on study)

• Seropositivity rate in patients on JAKs

  Visit 1 (day 1), Visit 3 (up to 140 days on study), Visit 4 (up to 360 days)

Study Arms (1)

Adults with IBD

EXPERIMENTAL

Biological: Adjuvanted Recombinant Zoster Vaccine (RZV)

Interventions

Adjuvanted Recombinant Zoster Vaccine (RZV) BIOLOGICAL

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.

Adults with IBD

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is between the ages of 19 and 85 years with a diagnosis of IBD based on standard clinical and histological criteria.
• Can provide appropriate written informed consent.
• Patient has a history of ulcerative colitis or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
• Patient is receiving one of the following treatments for their IBD:
• Anti-TNF therapy (infliximab, adalimumab, certolizumab, or golimumab)
• On anti-TNF monotherapy
• Or anti-TNF therapy in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6-Mercaptopurine (6MP) 0.5mg/kg
• Non-TNF therapy
• On ustekinumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
• On vedolizumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
• On Risankizumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
• On mirikizumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
• Janus Kinase Inhibitor
• On tofacitinib at least 5mg PO twice per day (BID)
• On upadactinib at least 15mg PO BID

You may not qualify if:

• Patient cannot or will not provide written informed consent.
• Patient has been taking any dose of oral or intravenous steroids for more than 3 days within 2 months prior to immunization.
• Any confirmed or suspected HIV, primary immunodeficiency disease, disseminated or untreated malignancy, or systemic infection.
• Previous vaccination against HZ or varicella within the 12M preceding the first dose of RZV.
• Occurrence of varicella or HZ per clinical history, within the 12M preceding the first dose of RZV.
• Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to the use of induction and/or maintenance immunosuppressive therapies.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment.
• Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.
• Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3 (i.e. 2 months after last dose of study V2).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• GlaxoSmithKline: collaborator

Study Sites (6)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

New York University

New York, New York, 10012, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

UW Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Freddy Caldera, DO, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open label, multicenter trial evaluating the safety and immunogenicity of recombinant herpes zoster vaccine in adults with IBD on immunosuppressive therapy.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)