Protocol Title: A Phase I/III Randomized, Double-blind study to evaluate the Safety and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants with Conditions Causing Immune Impairment
Brief Title: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA)

Sponsor: AstraZeneca

Protocol Number: D7000C00001

Key Criteria

  • Solid or hematologic malignancy
  • Solid organ transplant or stem cell transplant
  • Currently taking immunosuppressive therapy
  • B-cell depleting therapies in last year
  • Have a moderate or severe primary or secondary immunodeficiency (eg, for primary: DiGeorge syndrome, Wiskott-Aldrich syndrome, severe combined immunodeficiency, common variable immunodeficiency, agammaglobulinemia; eg, for secondary: hemodialysis)

Talking Points

No current COVID vaccine that was specifically tested in patients with cancer or with immune-compromised condition.

Travel to clinical trial is covered by sponsor.

Variants will continue with COVID – better to establish more protection for immune system.

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