← Back to Search

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 at 14 and 30 days after the study vaccine dose

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

I have completed 3 doses of either Moderna or Pfizer COVID-19 vaccine.

Select...

I understand the study and agree to participate.

Select...

I am on a specific immune-suppressing medication plan that includes CNI, mycophenolate, and possibly a low dose of prednisone.

Select...

I am 18 years old or older.

Select...

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.

Select...

I have not received any monoclonal antibody treatment or convalescent plasma in the last 30 days.

Select...

I am HIV positive.

Select...

I have not been treated for cancer in the past year, except for surgery on skin cancer.

Select...

My kidney function is severely reduced.

Select...

My daily medication includes specific immune suppressants not exceeding certain doses.

Select...

I do not have any ongoing infections that aren't being treated.

Select...

I received a COVID vaccine that is not Moderna or Pfizer.

Select...

I have received an organ transplant, but it was not a kidney.

Select...

I am taking medication to modulate my immune system, not for a transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 14 and 30 days after the study vaccine dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 14 and 30 days after the study vaccine dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 14 and 30 days after the study vaccine dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of participants who reach a SARS-CoV-2 S antibody level >5000 U/mL

Secondary study objectives

Interquartile range of Monogram pseudovirus antibody titers

Interquartile range of anti-RBD antibody concentration

Interquartile range of fold rise (FR)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 15Eligibility criteria met