Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine for COVID19 (disease)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of California San Diego Medical Center: Transplantation, San Diego, CA
COVID19 (disease)+3 More
Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

An open label, non-randomized pilot study in kidney transplant recipients who received a minimum of two doses 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

Eligible Conditions

  • COVID19 (disease)
  • Kidney
  • COVID-19

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for COVID19 (disease)

Study Objectives

1 Primary · 21 Secondary · Reporting Duration: 1 year following the study dose of vaccine

Year 1
Adverse Events of Special Interest (AESIs), including potential immune mediated diseases
Year 1
Serious adverse events
Day 30
Interquartile range of Monogram pseudovirus antibody titers
Median range of Monogram pseudovirus antibody titers
Day 30
Interquartile range of anti-RBD antibody concentration
Median range of anti-RBD antibody concentration
Day 30
The proportion of participants who reach a SARS-CoV-2 S antibody level >5000 U/mL
Day 7
Solicited local and systemic vaccine reactogenicity
Day 30
Median range of fold rise (FR) in Monogram pseudovirus antibody titers
Day 30
Interquartile range of fold rise (FR)
Median of fold rise (FR) in anti-RBD antibody concentration
Day 90
Change in pre-existing donor-specific anti-human leukocyte antigens (HLA) antibody
Day 30
Adverse Events
Day 60
Acute rejection
Death
Graft loss
Need for dialysis
Day 30
Composite that includes death, graft loss, need for dialysis, and acute rejection
Day 60
Treated acute cell-mediated allograft rejection (clinical or biopsy-proven)
Treated antibody-mediated allograft rejection (clinical or biopsy-proven)
Day 90
Development of de novo donor-specific anti-human leukocyte antigens (HLA) antibody
Day 30
Interquartile range of fold rise (FR) in Monogram pseudovirus antibody titers

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for COVID19 (disease)

Trial Design

1 Treatment Group

Kidney transplant recipients
1 of 1
Experimental Treatment

80 Total Participants · 1 Treatment Group

Primary Treatment: Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine · No Placebo Group · Phase 2

Kidney transplant recipients
Biological
Experimental Group · 1 Intervention: Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year following the study dose of vaccine
Closest Location: University of California San Diego Medical Center: Transplantation · San Diego, CA
Photo of san diego 1Photo of san diego 2Photo of san diego 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching COVID19 (disease)
0 CompletedClinical Trials

Who is running the clinical trial?

PPDIndustry Sponsor
144 Previous Clinical Trials
32,019 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,108 Previous Clinical Trials
4,672,364 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,033 Previous Clinical Trials
30,782,295 Total Patients Enrolled
Sanofi Pasteur, a Sanofi CompanyIndustry Sponsor
378 Previous Clinical Trials
5,044,298 Total Patients Enrolled
Peter S Heeger, MDStudy ChairIcahn School of Medicine at Mount Sinai: Transplantation
2 Previous Clinical Trials
205 Total Patients Enrolled
Christian P. Larsen, MD, D.Phil.Study ChairEmory University School of Medicine: Transplantation
Dorry Segev, MD, Ph.D.Study ChairNew York University Langone Health-Transplantation

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have received a minimum of 2 doses of the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine as specified in the respective package inserts with the most recent dose given >30 days before enrollment.
You are of non-childbearing potential.
You are of childbearing potential and agree to use an effective contraceptive method or abstinence for 12 weeks post vaccine and while taking mycophenolate mofetil/mycophenolic acid.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.