Clinical trialNCT05518487CompletedPhase 2Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment15COVID-19Kidney Transplant

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Christian P. Larsen, MD, D.Phil.
Emory University School of Medicine: Transplantation
Study Chair
clinicaltrials.gov ↗
Christine Durand, MD
Johns Hopkins University
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Dorry Segev, MD, Ph.D.
New York University Langone Health-Transplantation
Study Chair
clinicaltrials.gov ↗
Peter S Heeger, MD
Icahn School of Medicine at Mount Sinai: Transplantation
Study Chair
clinicaltrials.gov ↗
William A. Werbel, MD
Johns Hopkins University
Study ChairKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

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

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 20 Feb 2023
Primary completion: 28 Feb 2024
Completion: 6 Nov 2024
Last update posted: 25 Jun 2025
Registered enrollment: 15
Registry id: NCT05518487

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.