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Virus Therapy
Sanofi-GSK COVID-19 Vaccine Booster for Low Antibody Levels After Vaccination (CPAT-SG Trial)
Phase 2
Waitlist Available
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
Must not have
Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months
Receipt of a monoclonal antibody product or convalescent plasma within the last 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year following the study dose of vaccine
Awards & highlights
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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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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 18 years old or older.
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I received a kidney transplant over a year ago and haven't had rejection issues in the last 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My transplant medication was changed due to rejection in the last 6 months.
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I have not received any monoclonal antibody treatment or convalescent plasma in the last 30 days.
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I am HIV positive.
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I have not been treated for cancer in the past year, except for surgery on skin cancer.
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My kidney function is severely reduced.
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My daily medication includes specific immune suppressants not exceeding certain doses.
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I do not have any ongoing infections that aren't being treated.
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I received a COVID vaccine that is not Moderna or Pfizer.
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I have received an organ transplant, but it was not a kidney.
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I am taking medication to modulate my immune system, not for a transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year following the study dose of vaccine
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year following the study dose of vaccine
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 moreTrial 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)
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Who is running the clinical trial?
PPDIndustry Sponsor
161 Previous Clinical Trials
36,900 Total Patients Enrolled
4 Trials studying COVID-19
216 Patients Enrolled for COVID-19
Johns Hopkins UniversityOTHER
2,285 Previous Clinical Trials
14,842,985 Total Patients Enrolled
34 Trials studying COVID-19
26,881 Patients Enrolled for COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,283 Previous Clinical Trials
5,498,852 Total Patients Enrolled
80 Trials studying COVID-19
292,388 Patients Enrolled for COVID-19
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Kidney transplant recipients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
COVID-19 Patient Testimony for trial: Trial Name: NCT05518487 — Phase 2
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