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Sanofi-GSK monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Phase 2

COVID-19 | Vaccines | Infectious Disease |Sanofi|Trials Updated: Jun 25, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Sanofi-GSK monovalent CoV2 preS dTM-AS03 COVID-19 vaccine clinical trials

Sanofi-GSK monovalent CoV2 preS dTM-AS03 COVID-19 vaccine · 1 trial · 2 indications

Phase 2 1
NCT05518487COVID Protection After Transplant - Sanofi GSK (CPAT-SG) StudyCOVID-19
COMPLETED15 Analytics
PHASE2COMPLETED
COVID Protection After Transplant - Sanofi GSK (CPAT-SG) Study
COVID-19
NCT0551848715
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Study Endpoints

Primary Endpoints

The Proportion of Participants Who Reach a SARS-CoV-2 S Antibody Level >5000 U/mL
At 30 days following a dose of vaccine

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

Secondary Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
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)

Interventions

NameTypeDescription
Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccineBIOLOGICAL0.5 mL per dose of the Sanofi-GSK COVID-19 Vaccine will be administered intramuscularly in the deltoid muscle of the upper arm
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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 C...

Countries:United States
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Competitive Landscape -COVID-19 55 trials

Top 8 of 10 competitors

CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE8PHASE3ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV
Merck & Co., Inc.MRK2PHASE3Molnupiravir
Invivyd, Inc.IVVD3PHASE3VYD2311
Vanda Pharmaceuticals Inc.VNDA1PHASE3Tradipitant
Moderna, Inc.MRNA2PHASE2mRNA-1283, mRNA-1273
GeoVax Labs, Inc.GOVX1PHASE2GEO-CM04S1
ImmunityBio IncIBRX2PHASE2Nogapendekin alfa inbakicept
Gilead Sciences, Inc.GILD1PHASE2Remdesivir
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