CD2H COVID-19

COVID Protection After Transplant - Sanofi GSK (CPAT-SG) Study

Purpose

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

Conditions

COVID-19
Kidney Transplant

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Kidney transplant recipients	This single-arm trial will administer a single dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine to kidney transplant recipients who demonstrate a persistently low (=< 2500 u/mL) anti-spike antibody response after completion of primary series and bivalent booster of either the Moderna COVID-19 Vaccine or the Pfizer-BioNTech Vaccine, as described in their respective Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs)	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

Recruiting Locations

More Details

NCT ID: NCT05518487
Status: Active, not recruiting
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.