Immunogenicity of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease
Condition: IBD; Covid19 Vaccine
MeSH terms: COVID-19; Inflammatory Bowel Diseases
Study type: Observational

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.
    

Detailed description: 
      COVID-19 has a variable spectrum of illness with the majority of infection resulting in
      asymptomatic or mild disease. However certain healthy adults and immunosuppressed populations
      can develop severe or critical symptoms that require hospitalization or intensive care stay.
      Emerging evidence suggest that certain immunosuppressive medications used to treat patients
      with IBD such as anti-tumor necrosis factor (TNF) do not appear to confer an increased risk
      for severe COVID-19, but the risk appears to be higher for other agents such as
      corticosteroids. The efficacy of a candidate COVID-19 may be lower in immunosuppressed
      patients with IBD, since these patient populations may have lower responses to vaccines.
      Multiple studies have shown that patients with IBD have variability in their vaccine
      responses compared to healthy individuals. While many patients have a normal vaccine
      response, those treated with TNF agents or combination therapy (TNF inhibitors and
      immunomodulators) are more likely to mount a poor immune response. Furthermore, preliminary
      data suggest some novel regimens (such as vedolizumab) may not impact the immune response but
      there is insufficient data to know their impact on vaccine response. Thus, there is a
      critical need to determine whether patients with IBD will mount normal immune responses to a
      COVID-19 vaccine.

      This is a single center cross sectional clinical study of 260 patients with IBD who are
      receiving the COVID-19 vaccine as standard of care. After obtaining informed consent,
      individuals who meet the inclusion criteria and none of the exclusion criteria will be
      invited to participate in the study.

      Aim 1. Determine the immunogenicity and safety of a COVID-19 vaccine in patients with IBD. To
      achieve this aim, the investigators will perform a prospective study evaluating the
      immunogenicity of a COVID-19 vaccine in 260 patients with IBD.

        -  Hypothesis: Systemic immunosuppressive regimens such as Anti-TNF in combination with an
           immunomodulator, associated with the lowest vaccine response, or other systemic
           immunosuppressive regimens will blunt the immunogenicity of a COVID-19 vaccine while
           other agents such as vedolizumab or aminosalicylates will not affect the vaccine
           response.

      Aim 2. Determine the impact of systemic immunosuppression on sustained antibody COVID-19
      concentrations in patients with IBD who received the COVID-19 vaccine. To achieve this aim,
      the investigators will evaluate sustained antibody concentrations using a quantitative assay
      from LabCorp that is currently being used by the Centers for Disease Control and Prevention
      (CDC) to evaluate seroprevalence and study immunity at 1, 6, 12, and 18 months after
      completion of vaccination. Labcorp activities are provided as a fee for service. Follow up
      In-Person visit 1 (one month visit) will be optional and participants can enter the study at
      the six months study visit (Follow up In-Person visit 2) or at approximately 1-2 month post
      third dose of the COVID-19 vaccine which has been approved for patients with IBD. The 12
      month visit (Follow up In-Person visit 3) may be replaced by a 6 month post 3rd dose vaccine
      if participants received one booster, or1-2 months post a 4th dose vaccine if participants
      received a second booster. The 18 month visit (Follow up In-Person visit 4) may substitute
      for a 12, 6, or 1-2 months post vaccine, depending on when and how many boosters the
      participant received.

        -  Hypothesis: Vaccine-induced antibody concentrations will wane over the 12 month interval
           faster than the published rate in healthcare workers.

      At the completion of the proposed research, the safety and immunogenicity of a COVID-19
      vaccine in immunosuppressed patients with IBD will be determined.

      Protocol Amendment Approved 2/24/2022 changes time points of data collection to 18 months
      post-2nd dose, 9 month post-3rd dose, or 3-4 months post-4th dose.

      Protocol Amendment Approved 4/19/2022 changes time points of data collection to 18 months
      post-2nd dose, 12 month post-3rd dose, or 6 months post-4th dose.

      Protocol Amendment Approved 6/21/2022 indicates that follow up In-Person Visit 4 (will occur
      from July-October 2022 prior to a Fall 2022 COVID-19 booster. This blood draw can occur at
      any time after completion of any doses of a COVID-19 vaccine series). For participants who
      have not completed Visit 3 prior to July 2022, Visit 3 will be their last blood draw, which
      can occur from July-October 2022 prior to a Fall 2022 COVID-19 booster. This blood draw can
      occur at any time after completion of any doses of a COVID-19 vaccine series).
    

Intervention name(s): Serological Assay for SARS-CoV-2
Intervention type(s): Diagnostic Test
Intervention description(s): 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.
Observational model: Case-Control
Time perspective: Prospective
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.
      
Biospecimen description: 
      blood samples for IBD specific research