Immunogenicity of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease

NCT04818892 | Completed

• 6 other identifiers: 2021-0043A534250SMPH/MEDICINE/GASTROENTProtocol Version 6/6/2022MSN252947MSN253788
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this proposal is to evaluate the safety and immunogenicity of a COVID-19 vaccine in patients with Inflammatory Bowel Disease (IBD). This will help determine if immunosuppressive regimens impact COVID-19 vaccine response. The investigators will determine if certain groups may need more doses of a vaccine, with future adjuvanted vaccines or require a booster to maintain immunity. 260 participants with IBD and scheduled to get a COVID-19 vaccine will be recruited and can expect to be on study for 18 months.

Conditions

IBD; Covid19 Vaccine

Outcome Measures

Primary Outcomes (6)

• Change in Geometric Mean Titers (GMT) of SARS-CoV-2 Antibody Concentrations following mRNA COVID-19 vaccine series

  The primary endpoint will be evaluating the change in humoral immunity between the immunosuppressive and non-immunosuppressive IBD treatment regimens following the recommended doses mRNA COVID-19 vaccine series.

  baseline to 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose

• Sustained antibody concentrations of mRNA COVID-19 vaccines

  The investigators will evaluate sustained antibody concentrations of mRNA COVID-19 vaccines by using a quantitative assay from LabCorp that is currently being used by the CDC to evaluate seroprevalence.

  18 months post-2nd dose

• Sustained antibody concentrations of mRNA COVID-19 vaccines

  The investigators will evaluate sustained antibody concentrations of mRNA COVID-19 vaccines by using a quantitative assay from LabCorp that is currently being used by the CDC to evaluate seroprevalence.

  12 months post-3rd dose

• Sustained antibody concentrations of mRNA COVID-19 vaccines

  The investigators will evaluate sustained antibody concentrations of mRNA COVID-19 vaccines by using a quantitative assay from LabCorp that is currently being used by the CDC to evaluate seroprevalence.

  6 months post-4th dose

• Change in level of T-cell response after mRNA COVID-19 vaccine

  Investigators will evaluate sustained cell mediated immunity against Covid-spike proteins after completing the vaccine schedule of a mRNA COVID-19 vaccine.

  18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose

• Percentage of participants with detectable level of T-cell response after mRNA COVID-19 vaccine

  For each patient, peripheral blood monocytes (PBMCs) will be isolated. IFN-ϒ ELISpot, which detects both CD4 and CD8 T cell effectors, will be used to detect T-cell immunity to the Covid-spike protein or peptides. The plates will be read on an AID ELISpot reader (Cell Technology, Inc., Columbia MD, reader software v.3.1.1.). A positive response to antigen will be defined as a frequency that was significantly (p \< 0.05, two-tailed t test) greater than the mean of control no-antigen wells and detectable (i.e., \>1:100,000). T cell responses will be correlated to Covid-19 neutralizing antibody responses.

  18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose

Secondary Outcomes (9)

• Incidence of Adverse Events

  up to 1 month post final immunization

• Patient reported outcome 3 (PRO3) score

  baseline, 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose

• Simple Colitis Activity Index (SCAI) Questionnaire Score

  baseline, 18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose

• Seroconversion: assessed by percentages of participants with ≥4-fold rise in antibody titer

  1 month post-immunization

• Change in Geometric Mean Titers (GMT) of SARS-CoV-2 Antibody Concentrations following two doses of viral vector COVID-19 vaccine series

  baseline,18 months post-2nd dose, 12 months post-3rd dose, or 6 months post-4th dose

Study Arms (2)

IBD and Non-Immunosuppressive Group

Clinical diagnosis of IBD, non-systemic immunosuppressive therapies, and scheduled to take an mRNA vaccine for COVID-19

Diagnostic Test: Serological Assay for SARS-CoV-2

IBD and Immunosuppressive Group

Clinical diagnosis of IBD, treated with systemic immunosuppressive therapies, and scheduled to take an mRNA vaccine for COVID-19

Diagnostic Test: Serological Assay for SARS-CoV-2

Interventions

Serological Assay for SARS-CoV-2 DIAGNOSTIC_TEST

LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2.

IBD and Immunosuppressive Group; IBD and Non-Immunosuppressive Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with IBD and scheduled to receive a COVID-19 vaccine will be recruited from the University of Wisconsin Hospital and Clinics if they meet the inclusion and exclusion criteria. * Group A IBD patients on non-systemic immunosuppressive therapy: no therapy or aminosalicylates or vedolizumab therapy * Group B IBD patients on systemic immunosuppression Patients in both groups will have been on stable treatment for IBD for at least two months.

You may qualify if:

• For mRNA cohort:
• Participant has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
• On one of the following treatment regimens:
• Group A: Non-systemic immunosuppressive Group at least 75 participants
• Mesalamine monotherapy or no therapy for IBD
• Vedolizumab Therapy Group: on either vedolizumab monotherapy or combination therapy with methotrexate or azathioprine
• Group B: Systemic immunosuppressive Group at least 75 participants
• Thiopurine Therapy Group: on azathioprine at least 2.0mg/kg or 6MP 1.0mg/kg
• Anti-TNF Therapy Group: on maintenance therapy infliximab (at least 8 every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
• Anti-TNF Combination Therapy Group: on anti-TNF therapy as described above along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
• Ustekinumab Therapy Group: on either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
• Tofacitinib Therapy Group: on tofacitinib at least 5mg PO BID
• Corticosteroid Therapy Group: on any one of the systemic immunosuppressive groups and any dose of corticosteroids
• Participant has been on the same IBD treatment for at least two months.
• Participant is receiving an mRNA COVID-19 vaccine per standard of care recommended by their clinical provider or has started the COVID-19 series or finished the mRNA COVID-19 vaccine series within the past six months and would qualify for six month study visits or has received a third dose of the vaccine as standard of care.

You may not qualify if:

• For mRNA cohort:
• Allergy to COVID-19 vaccine or a component of it
• Participant cannot or will not provide written informed consent
• Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity
• For Viral vector cohort:
• Allergy to COVID-19 vaccine or a component of it
• Participant cannot or will not provide written informed consent.
• Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples for IBD specific research

Study Officials

• Freddy Caldera, DO, MS

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 26, 2021
• Study Start: March 26, 2021
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)