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

NCT05518487 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: DAIT COVID19-TB-04
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 6

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

Conditions

COVID-19; Kidney Transplant

Keywords

Kidney transplant; COVID-19; Vaccine

Outcome Measures

Primary Outcomes (1)

• The Proportion of Participants Who Reach a SARS-CoV-2 S Antibody Level >5000 U/mL

  The antibody is measured by using the Roche Elecsys(R) anti-RBD assay

  At 30 days following a dose of vaccine

Secondary Outcomes (16)

• Composite That Includes Death, Graft Loss, Need for Dialysis, and Acute Rejection

  Within 30 days following the study dose of vaccine

• Death

  Within 30 days or within 60 days of the study dose of vaccine

• Graft Loss

  Within 30 days or within 60 days of the study dose of vaccine

• Need for Dialysis

  Within 30 days or within 60 days of the study dose of vaccine

• Acute Rejection

  Within 30 days or within 60 days of the study dose of vaccine

Study Arms (1)

Kidney transplant recipients

EXPERIMENTAL

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

Interventions

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

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

Kidney transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and provide informed consent
• Individual ≥ 18 years of age.
• Recipient of kidney transplant ≥12 months prior to enrollment, without treated allograft rejection in the 6 months preceding enrollment
• Maintenance immunosuppressive regimen consisting of CNI and mycophenolate mofetil or mycophenolate, with or without ≤ 5mg/day prednisone or equivalent
• 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
• Receipt a COVID-19 bivalent mRNA booster (Moderna or Pfizer-BioNTech) \>30 days prior to enrollment.
• Serum antibody titer up to 2500 U/mL at ≥ 30 days from the last dose of mRNA COVID-19 vaccine and
• 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
• 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)
• A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
• 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
• 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 may not qualify if:

• 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
• Recipient of any organ other than a kidney
• Known current or prior Donor Specific Antibody (DSA)
• Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months
• Known diagnosis of COVID-19 since last antibody test
• Receipt of a monoclonal antibody product or convalescent plasma within the last 30 days
• 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)
• 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
• Receipt of any vaccine in the 30 days preceding the study vaccine or planned vaccines in the 30 days following the study vaccine
• Estimated Glomerular Filtration Rate \<30mL/min/1.73m\^2
• Receipt of any cellular depleting agent (e.g. Antithymocyte globulin (ATG), Rituximab, Alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment
• Receiving systemic immunomodulatory medication(s) for any condition other than transplant
• Any uncontrolled active infection
• Infection with human immunodeficiency virus (HIV)
• Maintenance immunosuppressive regimen that includes anything other than a CNI, mycophenolate/mycophenolate mofetil, and ≤ 5mg/day prednisone or equivalent

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• PPD Development, LP: collaborator
• Johns Hopkins University: collaborator
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (6)

University of California San Diego Medical Center: Transplantation

San Diego, California, 92093, United States

Location

UCSF School of Medicine: Transplantation

San Francisco, California, 94143, United States

Location

Emory University School of Medicine: Transplantation

Atlanta, Georgia, 30332, United States

Location

University of Illinois Medical Center: Transplantation

Chicago, Illinois, 60612, United States

Location

Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit

Baltimore, Maryland, 21287, United States

Location

University of Wisconsin School of Medicine and Public Health: Transplantation

Madison, Wisconsin, 53706, United States

Location

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsGov@niaid.nih.gov

301-594-7669

Study Officials

• 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

  STUDY CHAIR

• Christine Durand, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 26, 2022
• Study Start: February 20, 2023
• Primary Completion: February 28, 2024
• Study Completion: November 6, 2024
• Last Updated: June 25, 2025
• Results First Posted: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: On average, within 24 months after database lock for the trial.
• Access Criteria: Open access.

Locations

US (6)