Sanofi-GSK COVID-19 Vaccine Booster for Low Antibody Levels After Vaccination
(CPAT-SG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new COVID-19 vaccine booster from Sanofi-GSK to enhance antibody levels in kidney transplant recipients. These individuals, despite receiving other COVID-19 vaccines, still have low antibody levels, increasing their vulnerability to the virus. The trial aims to determine if this booster can enhance their protection. Individuals who have had a kidney transplant, are on specific medications, and have low antibody levels after previous COVID-19 vaccinations might be suitable candidates for this study. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it does require that your immunosuppressive regimen includes specific drugs like CNI and mycophenolate, with or without a small dose of prednisone. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that the Sanofi-GSK monovalent COVID-19 vaccine is generally well-tolerated. Studies are ongoing to assess its safety and effectiveness for kidney transplant recipients, who often have weaker immune responses to vaccines. Early safety data from similar studies suggest that the vaccine does not cause serious side effects. Most people reported only mild reactions, such as sore arms or brief fatigue.
Since this vaccine is in a Phase 2 trial, it has already passed initial safety checks in earlier studies, indicating reasonable safety for people. Additionally, the vaccine includes an ingredient called adjuvant AS03, which has been used safely in other vaccines. Always consult your healthcare provider to understand more about the potential risks and benefits.12345Why do researchers think this study treatment might be promising?
The Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine is unique because it targets the specific B.1.351 variant, which is different from the broader focus of current vaccines like Moderna and Pfizer-BioNTech. This specialized approach could offer enhanced protection for kidney transplant recipients with low antibody levels. Researchers are excited about this treatment because it uses an adjuvant system (AS03) designed to boost the immune response even in individuals who have not responded adequately to previous vaccines.
What evidence suggests that the Sanofi-GSK COVID-19 vaccine booster could be effective for low antibody levels in kidney transplant recipients?
Research has shown that the Sanofi-GSK monovalent COVID-19 vaccine, which participants in this trial will receive, can increase antibody levels in people with weakened immune systems, such as kidney transplant recipients. In earlier studies, this vaccine effectively created a strong immune response, especially against certain COVID-19 strains. The vaccine includes an adjuvant, a substance that helps the body produce more antibodies—proteins that fight viruses. Unpublished data suggest that the antibody response from this vaccine is similar to other approved vaccines, potentially aiding those who didn't respond well to other COVID-19 vaccines.12567
Who Is on the Research Team?
Christine Durand, MD
Principal Investigator
Johns Hopkins University
William A. Werbel, MD
Principal Investigator
Johns Hopkins University
Dorry Segev, MD, Ph.D.
Principal Investigator
New York University Langone Health-Transplantation
Peter S Heeger, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai: Transplantation
Christian P. Larsen, MD, D.Phil.
Principal Investigator
Emory University School of Medicine: Transplantation
Are You a Good Fit for This Trial?
Adult kidney transplant recipients who've had a full primary series and booster of mRNA COVID-19 vaccines but still have low antibody levels. They must be on stable immunosuppressants, not pregnant or breastfeeding, and agree to contraception if necessary. Excluded are those with severe illnesses, other organ transplants, certain infections like HIV, recent receipt of monoclonal antibodies or convalescent plasma, and unstable medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
PPD DEVELOPMENT, LP
Industry Sponsor
David Simmons
PPD DEVELOPMENT, LP
Chief Executive Officer since 2012
BSc in Applied Science from Georgia Institute of Technology
Martina Flammer
PPD DEVELOPMENT, LP
Chief Medical Officer since 2024
MD
PPD Development, LP
Industry Sponsor
PPD
Industry Sponsor
Dr. Austin Smith
PPD
Chief Medical Officer since 2020
Doctor of Medicine from the Royal College of Surgeons in Ireland
David Simmons
PPD
Chief Executive Officer since 2012
Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University
Johns Hopkins University
Collaborator
Sanofi Pasteur, a Sanofi Company
Industry Sponsor
Paul Hudson
Sanofi Pasteur, a Sanofi Company
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Dr. Thomas Triomphe
Sanofi Pasteur, a Sanofi Company
Chief Medical Officer since 2020
MD from Tehran University of Medical Sciences