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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
15
0.5 mL per dose of the Sanofi-GSK COVID-19 Vaccine will be administered intramuscularly in the deltoid muscle of the upper arm
University of California San Diego Medical Center: Transplantation
San Diego, California, United States
UCSF School of Medicine: Transplantation
San Francisco, California, United States
Emory University School of Medicine: Transplantation
Atlanta, Georgia, United States
University of Illinois Medical Center: Transplantation
Chicago, Illinois, United States
Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit
Baltimore, Maryland, United States
University of Wisconsin School of Medicine and Public Health: Transplantation
Madison, Wisconsin, United States
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
Time frame: At 30 days following a dose of vaccine
Composite That Includes Death, Graft Loss, Need for Dialysis, and Acute Rejection
Time frame: Within 30 days following the study dose of vaccine
Death
Time frame: Within 30 days or within 60 days of the study dose of vaccine
Graft Loss
Time frame: Within 30 days or within 60 days of the study dose of vaccine
Need for Dialysis
Time frame: Within 30 days or within 60 days of the study dose of vaccine
Acute Rejection
Time frame: Within 30 days or within 60 days of the study dose of vaccine
Local Vaccine Reactogenicity
Time frame: Collected for 7 days following the study dose of vaccine)
Systemic Vaccine Reactogenicity
Time frame: Collected for 7 days following the study dose of vaccine)
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)
Time frame: 1 year following the study dose of vaccine
Treated Acute Cell-mediated Allograft Rejection (Clinical or Biopsy-proven)
Time frame: Within 60 days following the study dose of vaccine
Treated Antibody-mediated Allograft Rejection (Clinical or Biopsy-proven)
Time frame: Within 60 days following the study dose of vaccine
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
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
Anti-RBD Antibody Concentration
The antibody is measured by using the Roche Elecsys(R) anti-RBD assay
Time frame: At 30 days after the study dose of vaccine
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.
Time frame: From baseline to 30 days after the study dose of vaccine
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
Time frame: At 14 and 30 days after the study vaccine dose
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)
Time frame: From baseline to 14 and 30 days after the study vaccine dose
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