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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05518487
Recruitment Status : Not yet recruiting
First Posted : August 26, 2022
Last Update Posted : November 4, 2022
Sponsor:
Collaborators:
PPD
Johns Hopkins University
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

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


Condition or disease Intervention/treatment Phase
COVID-19 Kidney Transplant Biological: Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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)
Estimated Study Start Date : November 10, 2022
Estimated Primary Completion Date : July 15, 2023
Estimated Study Completion Date : July 15, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The proportion of participants who reach a SARS-CoV-2 S antibody level >5000 U/mL [ Time Frame: At 30 days following a dose of vaccine ]
    The antibody is measured by using the Roche Elecsys(R) anti-RBD assay


Secondary Outcome Measures :
  1. Composite that includes death, graft loss, need for dialysis, and acute rejection [ Time Frame: Within 30 days following the study dose of vaccine ]
  2. Death [ Time Frame: Within 30 days and 60 days of the study dose of vaccine ]
  3. Graft loss [ Time Frame: Within 30 days and 60 days of the study dose of vaccine ]
  4. Need for dialysis [ Time Frame: Within 30 days and 60 days of the study dose of vaccine ]
  5. Acute rejection [ Time Frame: Within 30 days and 60 days of the study dose of vaccine ]
  6. Solicited local and systemic vaccine reactogenicity [ Time Frame: Collected for 7 days following the study dose of vaccine) ]
  7. Adverse Events [ Time Frame: Up to 30 days after the study dose of vaccine ]
  8. Serious adverse events [ Time Frame: 1 year following the study dose of vaccine ]
  9. Adverse Events of Special Interest (AESIs), including potential immune mediated diseases [ Time Frame: 1 year following the study dose of vaccine ]
  10. Treated acute cell-mediated allograft rejection (clinical or biopsy-proven) [ Time Frame: Within 60 days following the study dose of vaccine ]
  11. Treated antibody-mediated allograft rejection (clinical or biopsy-proven) [ Time Frame: Within 60 days following the study dose of vaccine ]
  12. Development of de novo donor-specific anti-human leukocyte antigens (HLA) antibody [ Time Frame: Within 90 days of the vaccine and up to 12-months post vaccine ]
  13. Change in pre-existing donor-specific anti-human leukocyte antigens (HLA) antibody [ Time Frame: From study entry to 90 days post vaccine and up to 12-months post vaccine ]
  14. Median range of anti-RBD antibody concentration [ Time Frame: At 30 days after the study dose of vaccine ]
    The antibody is measured by using the Roche Elecsys(R) anti-RBD assay

  15. Interquartile range of anti-RBD antibody concentration [ Time Frame: At 30 days after the study dose of vaccine ]
    The antibody is measured by using the Roche Elecsys(R) anti-RBD assay

  16. Median of fold rise (FR) in anti-RBD antibody concentration [ Time Frame: From baseline to 30 days after the study dose of vaccine ]
    The antibody is measured by using the Roche Elecsys(R) anti-RBD assay

  17. Interquartile range of fold rise (FR) [ Time Frame: From baseline to 30 days after the study dose of vaccine ]
    The antibody is measured by using the Roche Elecsys(R) anti-RBD assay

  18. Median range of Monogram pseudovirus antibody titers [ Time Frame: At 14 and 30 days after the study vaccine dose ]
    For selected variants of concern (prototype (Wuhan), beta, and omicron BA.1; additional alternative strains to be determined based on assay availability)

  19. Interquartile range of Monogram pseudovirus antibody titers [ Time Frame: At 14 and 30 days after the study vaccine dose ]
    For selected variants of concern (prototype (Wuhan), beta, and omicron BA.1; additional alternative strains to be determined based on assay availability)

  20. Median range of fold rise (FR) in Monogram pseudovirus antibody titers [ Time Frame: From baseline to 14 and 30 days after the study vaccine dose ]
    For selected variants of concern (prototype (Wuhan), beta, and omicron BA.1; additional alternative strains to be determined based on assay availability)

  21. Interquartile range of fold rise (FR) in Monogram pseudovirus antibody titers [ Time Frame: from baseline to 14 and 30 days after the study vaccine dose ]
    For selected variants of concern (prototype (Wuhan), beta, and omicron BA.1; additional alternative strains to be determined based on assay availability)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05518487


Locations
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United States, California
University of California San Diego Medical Center: Transplantation
San Diego, California, United States, 92093
UCSF School of Medicine: Transplantation
San Francisco, California, United States, 94143
United States, Georgia
Emory University School of Medicine: Transplantation
Atlanta, Georgia, United States, 30332
United States, Illinois
University of Illinois Medical Center: Transplantation
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit
Baltimore, Maryland, United States, 21287
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health: Transplantation
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
PPD
Johns Hopkins University
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Chair: Dorry Segev, MD, Ph.D. New York University Langone Health-Transplantation
Study Chair: Peter S Heeger, MD Icahn School of Medicine at Mount Sinai: Transplantation
Study Chair: Christian P. Larsen, MD, D.Phil. Emory University School of Medicine: Transplantation
Study Chair: William A. Werbel, MD Johns Hopkins University
Principal Investigator: Christine Durand, MD Johns Hopkins University
Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT05518487    
Other Study ID Numbers: DAIT COVID19-TB-04
First Posted: August 26, 2022    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Time Frame: On average, within 24 months after database lock for the trial.
Access Criteria: Open access.
URL: https://www.immport.org/home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Kidney transplant
COVID-19
Vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases