for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Principal Investigator
by Monica Fung, MD
Headshot of Monica Fung
Monica Fung



An open label, non-randomized pilot study in kidney transplant recipients who received a completed primary series and bivalent booster of mRNA based COVID-19 vaccine and have =<2500 U/mL SARS-CoV-2 S antibody concentration using the Roche Elecsys(R) anti-RBD assay. Up to 80 participants will be enrolled in this study. Eligible participants will receive a dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine candidate..

The primary objective is to determine whether a booster dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine will elicit an increased SARS-CoV-2 antibody response in participants who have failed to maintain an antibody titer >2500 U/mL (using the Roche Elecsys(R) anti-RBD assay) to 2 or more doses of mRNA based COVID-19 vaccine

Official Title

Safety and Immunogenicity of a Dose of the Sanofi-GSK Monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 Vaccine in Kidney Transplant Recipients With a Persistently Low SARS CoV-2 Antibody Titer (COVID19-TB-04)


COVID-19, Kidney Transplant, Vaccine, Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine, Kidney transplant recipients


You can join if…

Open to people ages 18 years and up

  1. Able to understand and provide informed consent
  2. Individual ≥ 18 years of age.
  3. Recipient of kidney transplant >=12 months prior to enrollment, without treated allograft rejection in the 6 months preceding enrollment
  4. Maintenance immunosuppressive regimen consisting of CNI and mycophenolate mofetil or mycophenolate, with or without <= 5mg/day prednisone or equivalent
  5. Received completed primary series (3 doses) of mRNA vaccine (either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine) as specified in the respective package inserts
  6. Receipt a COVID-19 bivalent mRNA booster (Moderna or Pfizer-BioNTech) >30 days prior to enrollment.
  7. Serum antibody titer up to 2500 U/mL at >=30 days from the last dose of mRNA COVID-19 vaccine and =>30 days following receipt of a monoclonal antibody product or convalescent plasma for COVID-19, measured using the Roche Elecsys(R) anti-SARS-CoV-2 S assay
  8. Platelet count greater than 30,000/cu mm must be confirmed in participants with a known history of bleeding disorder or thrombocytopenia (platelet count <50,000/cu mm)
  9. A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
    1. Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile


    2. Is of childbearing potential and agrees to use an effective contraceptive method or abstinence for 12 weeks post vaccine and while taking mycophenolate mofetil/mycophenolic acid

You CAN'T join if...

  1. Recipient of any number of doses of any COVID vaccine product other than the Moderna COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine
  2. Recipient of any organ other than a kidney
  3. Known current or prior Donor Specific Antibody (DSA)
  4. Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months
  5. Known diagnosis of COVID-19 since last antibody test
  6. Receipt of a monoclonal antibody product or convalescent plasma within the last 30 days
  7. Known history of hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. (components listed in Section 6, and the CoV2 and AS03 Investigator's Brochure)
  8. Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating intramuscular (IM) vaccination based on Investigator's judgment
  9. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >=38.0°C [>=100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided

    10. Receipt of any vaccine in the 30 days preceding the study vaccine or planned vaccines

    in the 30 days following the study vaccine

    11. Estimated Glomerular Filtration Rate <30mL/min/1.73m^2 12. Receipt of any cellular depleting agent (e.g. Antithymocyte globulin (ATG), Rituximab,

    Alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment

    13. Receiving systemic immunomodulatory medication(s) for any condition other than


    14. Any uncontrolled active infection 15. Infection with human immunodeficiency virus (HIV) 16. Maintenance immunosuppressive regimen that includes anything other than a CNI,

    mycophenolate/mycophenolate mofetil, and =< 5mg/day prednisone or equivalent

    17. Recent (within one year) or ongoing treatment for malignancy, except for definitive

    surgical treatment of localized skin cancers

    18. Any unstable acute or chronic illness, treatments, or findings which, in the opinion

    of the investigator, may pose additional risks from participation in the study, may interfere with the c candidate's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study


  • UCSF School of Medicine: Transplantation not yet accepting patients
    San Francisco California 94143 United States
  • University of California San Diego Medical Center: Transplantation not yet accepting patients
    San Diego California 92093 United States

Lead Scientist at UCSF

  • Monica Fung, MD
    Monica Fung specializes in infectious diseases with a focus on patients with compromised immune systems, including those with solid organ or stem cell transplants. She attends on the Immunocompromised and General Infectious Diseases Consult Services, and has clinics in the 360 Wellness Center and Infectious Diseases Faculty Practice at UCSF-Parnassus.


accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID) Division of Allergy, Immunology, and Transplantation (DAIT)
Phase 2 research study
Study Type
Expecting 80 study participants
Last Updated