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Virus Therapy

Sanofi-GSK COVID-19 Vaccine Booster for Low Antibody Levels After Vaccination (CPAT-SG Trial)

Phase 2
Recruiting
Led By Christine Durand, MD
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received completed primary series (3 doses) of mRNA vaccine (either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine) as specified in the respective package inserts
Able to understand and provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year following the study dose of vaccine
Awards & highlights

CPAT-SG Trial Summary

This trial is testing whether a booster dose of a different COVID-19 vaccine will help people who have already received two doses of a different mRNA-based COVID-19 vaccine and have an antibody concentration that is below 2500 U/mL.

Who is the study for?
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.Check my eligibility
What is being tested?
The study is testing whether a Sanofi-GSK monovalent COVID-19 vaccine can boost the immune response in kidney transplant patients who didn't maintain high enough antibody levels after receiving mRNA vaccines. It's an open-label trial where all participants receive the vaccine without being compared to a control group.See study design
What are the potential side effects?
While specific side effects for this vaccine aren't listed here, common reactions to similar vaccines include soreness at injection site, fatigue, headache, muscle pain, chills, fever and nausea. Severe allergic reactions are rare but possible.

CPAT-SG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have completed 3 doses of either Moderna or Pfizer COVID-19 vaccine.
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I understand the study and agree to participate.
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My COVID-19 antibody levels are within the required range after vaccination and treatment.
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I am on a specific immune-suppressing medication plan that includes CNI, mycophenolate, and possibly a low dose of prednisone.
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I am not pregnant or breastfeeding, and I either cannot have children or will use birth control.
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I am 18 years old or older.
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I received a COVID-19 mRNA booster shot more than 30 days ago.
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I received a kidney transplant over a year ago and haven't had rejection issues in the last 6 months.

CPAT-SG Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year following the study dose of vaccine
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year following the study dose of vaccine for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of participants who reach a SARS-CoV-2 S antibody level >5000 U/mL
Secondary outcome measures
Acute rejection
Adverse Events
Adverse Events of Special Interest (AESIs), including potential immune mediated diseases
+18 more

CPAT-SG Trial Design

1Treatment groups
Experimental Treatment
Group I: Kidney transplant recipientsExperimental Treatment1 Intervention
This 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)

Find a Location

Who is running the clinical trial?

PPDIndustry Sponsor
159 Previous Clinical Trials
36,835 Total Patients Enrolled
4 Trials studying COVID-19
216 Patients Enrolled for COVID-19
Johns Hopkins UniversityOTHER
2,247 Previous Clinical Trials
14,816,738 Total Patients Enrolled
34 Trials studying COVID-19
26,895 Patients Enrolled for COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,620 Total Patients Enrolled
78 Trials studying COVID-19
292,128 Patients Enrolled for COVID-19

Media Library

Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05518487 — Phase 2
COVID-19 Research Study Groups: Kidney transplant recipients
COVID-19 Clinical Trial 2023: Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine Highlights & Side Effects. Trial Name: NCT05518487 — Phase 2
Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05518487 — Phase 2
COVID-19 Patient Testimony for trial: Trial Name: NCT05518487 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the safety measures taken to protect individuals from potential risks of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine?

"There is current research suggesting that Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine has some safety, thus this received a score of 2 on our 1 to 3 scale as the study is currently in Phase 2 and there no efficacy data available yet."

Answered by AI

How many medical institutions are conducting this clinical research in North America?

"This trial is being hosted at the Johns Hopkins Institute for Clinical and Translational Research in Baltimore, Maryland, UCSF School of Medicine: Transplantation in San Francisco, Georgia as well as Emory University School of Medicine: Transplantation located in Atlanta, Wisconsin. Additionally 6 other locations are currently enrolling patients."

Answered by AI

Is this medical experiment recruiting participants currently?

"The clinical trial, which was advertised on November 10th 2022 and last updated on October 31st 2022 is no longer recruiting participants. Nevertheless, there are 1113 other studies actively seeking volunteers to participate in their trials."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Texas
Other
California
What site did they apply to?
University of Illinois Medical Center: Transplantation
Other
University of California San Diego Medical Center: Transplantation
Emory University School of Medicine: Transplantation
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
2
0

What questions have other patients asked about this trial?

Can I do it in the next 10 days?
PatientReceived no prior treatments

Why did patients apply to this trial?

Just try new vaccine. To help myself cov 19. As a science major to help out in the name of research.
PatientReceived 2+ prior treatments
I like to support scientific research especially in covid...such a new area and info is needed.
PatientReceived no prior treatments
~31 spots leftby Feb 2025