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)
Brief Summary

An open label, non-randomized pilot study in kidney transplant recipients who received acompleted primary series and bivalent booster of mRNA based COVID-19 vaccine and have=2500U/mL (using the Roche Elecsys(R) anti-RBD assay) to 2 or more doses of mRNA basedCOVID-19 vaccine

Detailed Description

Not Provided

Active, not recruiting
COVID-19
Kidney Transplant

Biological: Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine

0.5 mL per dose of the Sanofi-GSK COVID-19 Vaccine will be administered intramuscularly
in the deltoid muscle of the upper arm

Eligibility Criteria

Inclusion Criteria:

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

OR

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

Exclusion Criteria:

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
transplant

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

University of California San Diego Medical Center: Transplantation
San Diego, California, United States

UCSF School of Medicine: Transplantation
San Francisco, California, United States

Emory University School of Medicine: Transplantation
Atlanta, Georgia, United States

University of Illinois Medical Center: Transplantation
Chicago, Illinois, United States

Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit
Baltimore, Maryland, United States

University of Wisconsin School of Medicine and Public Health: Transplantation
Madison, Wisconsin, United States

National Institute of Allergy and Infectious Diseases (NIAID)
NCT Number
Keywords
kidney transplant
Covid-19
Vaccine
MeSH Terms
COVID-19