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COVID-19Phase 2CPAT-SGNCT05518487

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

A Phase 2 study testing Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine in people with COVID-19 and Kidney Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, Kidney Transplant
What is being tested?
Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
6 sitesUnited States
Study dates
20 Feb 2023to 6 Nov 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • 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
  • OR
  • 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

Who cannot join

  • 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
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  • 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)
  • Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating intramuscular (IM) vaccination based on Investigator's judgment
  • 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
  • Recent (within one year) or ongoing treatment for malignancy, except for definitive surgical treatment of localized skin cancers
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Emory University School of Medicine: Transplantation

    Atlanta, Georgia, 30332

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

    Baltimore, Maryland, 21287

  • University of Illinois Medical Center: Transplantation

    Chicago, Illinois, 60612

  • University of Wisconsin School of Medicine and Public Health: Transplantation

    Madison, Wisconsin, 53706

  • University of California San Diego Medical Center: Transplantation

    San Diego, California, 92093

  • UCSF School of Medicine: Transplantation

    San Francisco, California, 94143

Other trials in United States

About this study

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)

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

Being tested
Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine
Keywords
Kidney transplant, COVID-19, Vaccine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccineBiological

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

Study groups in NCT05518487
Study groupRoleWhat they receive
Kidney transplant recipientsExperimentalThis 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)
Receives: Biological: Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At 30 days following a dose of vaccine

Secondary outcomes (16)

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

    Measured: Within 30 days following the study dose of vaccine

  2. Death

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

  3. Graft Loss

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

  4. Need for Dialysis

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

  5. Acute Rejection

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

  6. Local Vaccine Reactogenicity

    Measured: Collected for 7 days following the study dose of vaccine)

  7. Systemic Vaccine Reactogenicity

    Measured: Collected for 7 days following the study dose of vaccine)

  8. Adverse Events of Special Interest (AESIs), Including Potential Immune Mediated Diseases

    The categories of AESI that required special reporting in this protocol were: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; Potential immune-mediated diseases (pIMDs)

    Measured: 1 year following the study dose of vaccine

  9. Treated Acute Cell-mediated Allograft Rejection (Clinical or Biopsy-proven)

    Measured: Within 60 days following the study dose of vaccine

  10. Treated Antibody-mediated Allograft Rejection (Clinical or Biopsy-proven)

    Measured: Within 60 days following the study dose of vaccine

  11. Development of de Novo Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody

    Measured: Within 90 days of the vaccine and up to 12-months post vaccine

  12. Change in Pre-existing Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody

    Measured: From study entry to 90 days post vaccine and up to 12-months post vaccine

  13. Anti-RBD Antibody Concentration

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

    Measured: At 30 days after the study dose of vaccine

  14. Fold Rise (FR) in Anti-RBD Antibody Concentration

    The Fold Rise is the dimensionless ratio between each participant's day 30 antibody titer (in U/ml) and the participant's baseline antibody titer (in U/ml) antibody is the antibody titers are measured by using the Roche Elecsys(R) anti-RBD assay.

    Measured: From baseline to 30 days after the study dose of vaccine

  15. Monogram Pseudovirus Antibody Titers

    For selected variants of concern (prototype (Wuhan), beta, and omicron BA.1; additional alternative strains to be determined based on assay availability). tests unable to be performed

    Measured: At 14 and 30 days after the study vaccine dose

  16. Median Range of Fold Rise (FR) in Monogram Pseudovirus Antibody Titers

    For selected variants of concern (prototype (Wuhan), beta, and omicron BA.1; additional alternative strains to be determined based on assay availability)

    Measured: From baseline to 14 and 30 days after the study vaccine dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2022
  2. Study start20 Feb 2023
  3. Primary completion28 Feb 2024
  4. Study completion6 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05518487
Sponsor's protocol ID
DAIT COVID19-TB-04
Acronym
CPAT-SG
Status last verified
Jun 2025
First submitted
18 Aug 2022
Last updated
25 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine in people with COVID-19 and Kidney Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05518487.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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