CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccinebiological
Likely dose
Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05518487
NCT05518487Phase 2Completed
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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)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 26, 2022·Updated Jun 25, 2025

In Brief

A Phase 2 clinical trial evaluating Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine for COVID-19 and Kidney Transplant. Completed, enrolled 15 participants across 6 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19, Kidney Transplant
CountriesUnited States
CollaboratorsPPD Development, LP, Johns Hopkins University, Sanofi Pasteur, a Sanofi Company

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedAug 26, 2022
Enrollment StartFeb 20, 2023
Primary CompletionFeb 28, 2024
Study CompletionNov 6, 2024
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 3.9 years ago

Interventions

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