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Sanofi-GSK COVID-19 Vaccine Booster for Low Antibody Levels After Vaccination (CPAT-SG Trial)
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.
CPAT-SG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCPAT-SG Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CPAT-SG Trial Design
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Who is running the clinical trial?
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- You have had a severe allergic reaction to any of the ingredients in the vaccine before.I have completed 3 doses of either Moderna or Pfizer COVID-19 vaccine.I have a bleeding disorder or have taken blood thinners in the last 21 days.You have been diagnosed with COVID-19 since your last antibody test.I haven't received any vaccines in the last 30 days and don't plan to in the next 30 days.My transplant medication was changed due to rejection in the last 6 months.I have not received any monoclonal antibody treatment or convalescent plasma in the last 30 days.I understand the study and agree to participate.I am HIV positive.My COVID-19 antibody levels are within the required range after vaccination and treatment.My kidney function is severely reduced.I am on a specific immune-suppressing medication plan that includes CNI, mycophenolate, and possibly a low dose of prednisone.I am not pregnant or breastfeeding, and I either cannot have children or will use birth control.I have not been treated for cancer in the past year, except for surgery on skin cancer.My daily medication includes specific immune suppressants not exceeding certain doses.I do not have any ongoing infections that aren't being treated.I received a COVID vaccine that is not Moderna or Pfizer.I am 18 years old or older.I have received an organ transplant, but it was not a kidney.I do not have any health conditions that could make this study riskier for me or affect the results.I received a COVID-19 mRNA booster shot more than 30 days ago.You have or had specific antibodies from a donor.I haven't taken any cell-depleting drugs in the last year.I received a kidney transplant over a year ago and haven't had rejection issues in the last 6 months.I am taking medication to modulate my immune system, not for a transplant.If you have a history of bleeding disorder or low platelet count, your platelet count needs to be higher than 30,000/cu mm.
- Group 1: Kidney transplant recipients
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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