Open Actively Recruiting

COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders


Brief Summary

This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different COVID-19 vaccine booster doses in participants with autoimmune disease requiring immunosuppressive medications. All study participants will have negative serologic or sub-optimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S (RBD) result ≤ 50 U/mL) to initial COVID-19 vaccine regimen with Moderna COVID-19 vaccine, Pfizer-BioNTech COVID-19 vaccine, or Janssen COVID-19 vaccine.

The study will initially focus on 5 autoimmune diseases: - Systemic Lupus Erythematosus (SLE) - Rheumatoid Arthritis (RA) - Multiple Sclerosis (MS) - Systemic Sclerosis (SSc), and - Pemphigus.

Primary Purpose
Study Type
Phase 2


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

Inclusion Criteria:

Individuals who meet all the following criteria are eligible for enrollment as study participants-

  • Individuals that meet classification criteria for:
    • systemic lupus erythematosus (SLE)
    • systemic sclerosis (SSc)
    • rheumatoid arthritis (RA)
    • multiple sclerosis (MS), or
    • pemphigus
  • Participants must meet:
    • the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) or the 2012 Systemic Lupus International Collaborating Clinics Classification Criteria (SLICC) classification criteria for SLE
    • the 2010 ACR/EULAR classification criteria for RA
    • the 2013 EULAR/ACR classification criteria for SSc
    • the 2017 McDonald criteria for MS, and
    • the international consensus criteria for pemphigus Note: If a participant has been diagnosed with more than one autoimmune disease, the participant will be assessed based on the disease that is selected for study entry
  • Willing and able to sign informed consent
  • Documented full COVID-19 vaccination (e.g., Centers for Disease Control and Prevention [CDC] vaccination card or documentation in medical records) that was completed ≥ 4 weeks prior and no more than 36 weeks prior to the Screening visit
  • Negative serologic or suboptimal response to initial COVID-19 vaccine regimen- defined as an Elecsys® Anti-Severe Acute Respiratory Syndrome Coronavirus-2 (anti-SARS-CoV-2-spike (S) protein receptor binding domain (RBD)) result ≤ 50 U/mL at Screening visit -Initial COVID-19 vaccine regimen is defined as either:
    • 2 doses of the Pfizer-BioNTech COVID-19 vaccine
    • 2 doses of the Moderna COVID-19 vaccine, or
    • A single dose of the Janssen COVID-19 vaccine
  • Must be currently taking one of the following immunosuppressive medications with or without additional disease related medications:
    • mycophenolate mofetil (minimum of 1,000 mg per day)/mycophenolic acid (minimum of 720 mg per day)
    • methotrexate (minimum of 7.5mg per week), or
    • B cell depleting agents within the past 12 months (such as rituximab, ocrelizumab, ofatumumab)
      • If taking mycophenolate mofetil (MMF)/mycophenolic acid (MPA) or methotrexate (MTX), the participant should have initiated therapy at least 8 weeks prior to randomization and be taking the same medications (regardless of dose) as at the time of the initial COVID-19 vaccine regimen
      • Participants on B cell depleting therapy may enter the study if they are also taking MMF/MPA or MTX. In this case, the MMF/MPA or MTX would not be withheld for the vaccine booster dose(s)
      • Participants taking both MMF/MPA and MTX will be excluded from the study
  • No changes in background immunosuppressive medications in the 8 weeks prior to Screening, excluding the following:
    • hydroxychloroquine (HCQ)
    • Intraarticular steroids
    • The addition of prednisone at ≤10 mg per day or prednisone at any dose when given for ≤ 3 days, and
    • Corticosteroid bursts for non-autoimmune disease-related conditions, such as asthma or chronic obstructive pulmonary disease (COPD), are permitted

Exclusion Criteria:

Individuals who meet any of these criteria are not eligible for enrollment as study participants-

  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • History of severe allergic reaction to the initial COVID-19 vaccine regimen, or any component of any of the COVID-19 vaccines, or to polyethylene glycol (PEG)
  • Ongoing treatment for a malignancy with chemotherapy or immunotherapy
  • Active disease (per the Investigator's decision) resulting in inability to hold the immunosuppressive therapy in the Mycophenolate Mofetil (MMF)/Mycophenolic Acid (MPA) or Methotrexate (MTX) arms of the study The potential impact of temporarily holding medication for participants with a recent mild disease flare within 4 weeks should be carefully considered
  • Active disease during the Screening period resulting in:
    • an increase/addition of immunosuppressive medications, or
    • a suggestion of multiple sclerosis (MS) relapse per the investigator
  • Recent or current Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection defined as:
    • Documented SARS-CoV-2 infection in the past 30 days (from the day the participant is diagnosed by positive test to Screening), or
    • A positive result on a molecular COVID-19 test at Screening
  • Receipt of a COVID-19 vaccine booster prior to Screening with the Moderna COVID-19 vaccine, Pfizer-BioNTech COVID-19 vaccine, or Janssen COVID-19 vaccine
  • Participants with:
    • a history of autoimmune disease-related myocarditis within 3 years
    • autoimmune disease-related pericarditis within the past year, or
    • inflammatory myocarditis/pericarditis following initial COVID-19 vaccine regimen
  • Participants with active bacterial or viral infections who have received antibiotics within the 14 days prior to Screening, including participants with evidence of:
    • Human Immunodeficiency Virus (HIV)
    • Hepatitis B as indicated by surface antigen or hepatitis B core antibody positivity
    • Hepatitis C as indicated by anti-hepatitis C antibody positivity
      • Note: If a participant is Hepatitis C antibody positive, they will be eligible to participate in the study if he/she is negative for viral load at Screening
  • Participants with common variable immunodeficiency disease, as well as any participants currently receiving immune globulin replacement therapy
  • Participants who received licensed or investigational monoclonal antibodies or plasma products directed against SARS-CoV-2 within 90 days of Screening
  • Participants who have received any live vaccines within 2 months of the anticipated study vaccine dose or who will have need of a live vaccine at any time during the study
  • Participants with history of arterial or venous thrombosis, and/or history of recurrent miscarriages associated with clotting antibodies (anticardiolipin antibodies, anti-beta-2 glycoprotein I antibodies, and positive lupus anticoagulant)
  • Participants with a history of heparin-induced thrombocytopenia (HIT) or thrombotic thrombocytopenic purpura (TTP)
  • Currently pregnant or breastfeeding
  • Participants who are planning a pregnancy during the course of the trial
  • Hemoglobin (Hgb) < 8.0 g/dL (80 g/L)
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator:
    • may pose additional risks from participation in the study
    • may interfere with the participant's ability to comply with study requirements, or
    • that may impact the quality or interpretation of the data obtained from the study
  • Other investigational chemical agent within 30 days or other investigational biologic agent within 8 weeks or 5 half-lives (whichever is longer) of enrollment
  • Concurrent treatment with cyclophosphamide, cladribine, alemtuzumab, or mitoxantrone
  • Any increase in disease activity at Screening that would necessitate a change in medications
  • Participants currently on any type of dialysis, or who have received a solid organ transplant
  • Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Join this Trial

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Study Stats
Protocol No.
Mia Vasquez-Gutierrez
  • UCLA Westwood
For Providers
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