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

COVID-19 Clinical Trial

— CPAT-SG  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05518487
• Other study ID #: DAIT COVID19-TB-04
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 20, 2023
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 2025
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Kidney Transplant

Intervention

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

Locations

Country	Name	City	State
United States	Emory University School of Medicine: Transplantation	Atlanta	Georgia
United States	Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit	Baltimore	Maryland
United States	University of Illinois Medical Center: Transplantation	Chicago	Illinois
United States	University of Wisconsin School of Medicine and Public Health: Transplantation	Madison	Wisconsin
United States	University of California San Diego Medical Center: Transplantation	San Diego	California
United States	UCSF School of Medicine: Transplantation	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Johns Hopkins University, PPD, Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Composite that includes death, graft loss, need for dialysis, and acute rejection		Within 30 days following the study dose of vaccine
Secondary	Death		Within 30 days and 60 days of the study dose of vaccine
Secondary	Graft loss		Within 30 days and 60 days of the study dose of vaccine
Secondary	Need for dialysis		Within 30 days and 60 days of the study dose of vaccine
Secondary	Acute rejection		Within 30 days and 60 days of the study dose of vaccine
Secondary	Solicited local and systemic vaccine reactogenicity		Collected for 7 days following the study dose of vaccine)
Secondary	Adverse Events		Up to 30 days after the study dose of vaccine
Secondary	Serious adverse events		1 year following the study dose of vaccine
Secondary	Adverse Events of Special Interest (AESIs), including potential immune mediated diseases		1 year following the study dose of vaccine
Secondary	Treated acute cell-mediated allograft rejection (clinical or biopsy-proven)		Within 60 days following the study dose of vaccine
Secondary	Treated antibody-mediated allograft rejection (clinical or biopsy-proven)		Within 60 days following the study dose of vaccine
Secondary	Development of de novo donor-specific anti-human leukocyte antigens (HLA) antibody		Within 90 days of the vaccine and up to 12-months post vaccine
Secondary	Change in pre-existing donor-specific anti-human leukocyte antigens (HLA) antibody		From study entry to 90 days post vaccine and up to 12-months post vaccine
Secondary	Median range of anti-RBD antibody concentration	The antibody is measured by using the Roche Elecsys(R) anti-RBD assay	At 30 days after the study dose of vaccine
Secondary	Interquartile range of anti-RBD antibody concentration	The antibody is measured by using the Roche Elecsys(R) anti-RBD assay	At 30 days after the study dose of vaccine
Secondary	Median of fold rise (FR) in anti-RBD antibody concentration	The antibody is measured by using the Roche Elecsys(R) anti-RBD assay	From baseline to 30 days after the study dose of vaccine
Secondary	Interquartile range of fold rise (FR)	The antibody is measured by using the Roche Elecsys(R) anti-RBD assay	From baseline to 30 days after the study dose of vaccine
Secondary	Median range of 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)	At 14 and 30 days after the study vaccine dose
Secondary	Interquartile range of 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)	At 14 and 30 days after the study vaccine dose
Secondary	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)	From baseline to 14 and 30 days after the study vaccine dose
Secondary	Interquartile 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)	from baseline to 14 and 30 days after the study vaccine dose