Table 1.

Exclusion criteria on autoimmune disease and immunosuppression for each vaccine RCT.

Vaccine (ClinicalTrials.gov Identifier)Autoimmune Disease Exclusion Criteria
AstraZeneca1 (NCT04400838)
  • Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days)

  • Phase I/II: any autoimmune conditions, except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy

Moderna20 (NCT04470427)
  • Immunosuppressive or immunodeficient state, including HIV infection, asplenia, and recurrent severe infections

  • Has received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to screening (for corticosteroids ≥ 20 mg/d of prednisone equivalent)

  • Phase I only: individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention

Pfizer-BioNTech11 (NCT04368728)
  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination

  • Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, for an autoimmune disease, or planned receipt throughout the study

  • Phase I only: individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention

Novovax (NCT04583995)
  • Any autoimmune disease/condition (iatrogenic or congenital)

  • Any confirmed or suspected immunosuppressive or immunodeficient state

  • Chronic administration (defined as > 14 continuous days) of immunosuppressant medication within the past 3 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days; for corticosteroids ≥ 10 mg/d of prednisone equivalent)

  • RCT: randomized controlled trial.