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Vaccine

mRNA-1273 vaccine (Pfizer/BioNTech) for Kidney Transplant Recipients (CPAT Trial)

Phase 2
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 365 post-vaccination (dose 3)
Awards & highlights

CPAT Trial Summary

This trial is looking for kidney transplant patients who have not had an adequate response to two doses of either the Moderna or Pfizer vaccine to see if a third dose will elicit an antibody response.

Eligible Conditions
  • Kidney Transplant Recipients

CPAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 365 post-vaccination (dose 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 365 post-vaccination (dose 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antibody Response to Third Dose of mRNA COVID-19 Vaccine
Secondary outcome measures
Frequency of Any Serious Adverse Events (SAEs)
Frequency of Any Unsolicited Adverse Events (AEs)
Frequency of Solicited Local Allergic Reaction Adverse Events (AEs) to the mRNA-Based COVID-19 Vaccine
+7 more

Side effects data

From 2023 Phase 2 trial • 81 Patients • NCT04969263
40%
Vaccination complication
22%
Fatigue
11%
Lymphocyte count decreased
11%
Headache
9%
Creatinine urine increased
7%
Hyperkaliemia
7%
Diarrhea
7%
Myalgia
7%
Anemia
6%
White blood cell count decreased
5%
Arthralgia
5%
Urinary tract infection
4%
Chronic kidney disease
4%
Injection site erythema
4%
Dizziness
4%
Hyponatremia
4%
Blood Bicarbonate decreased
2%
Pain
2%
COVID-19
2%
Decreased appetite
2%
Nausea
2%
Pyrexia
2%
Contusion
1%
Oedema peripheral
1%
Death
1%
Diverticulitis
1%
Gastrointestinal disorder
1%
Pneumonia
1%
Pyelonephritis
1%
Hypercalcemia
1%
Urinary retention
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anti-RBD Negative or Low

CPAT Trial Design

2Treatment groups
Experimental Treatment
Group I: mRNA-1273 vaccine (Pfizer/BioNTech)Experimental Treatment1 Intervention
The mRNA-1273 vaccine was developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. Kidney transplant recipients who had a suboptimal antibody response to the standard two doses of vaccination with Pfizer/BioNTech will receive a third dose of the the same vaccine. Administration: One dose administered intramuscularly, upper arm.
Group II: mRNA-1273 vaccine (Moderna)Experimental Treatment1 Intervention
The mRNA-1273 vaccine was developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. Kidney transplant recipients who had a suboptimal antibody response to the standard two doses of vaccination with Moderna will receive a third dose of the same vaccine. Administration: One dose administered intramuscularly, upper arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moderna COVID-19 Vaccine
FDA approved
Moderna COVID-19 Vaccine
FDA approved

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,156 Total Patients Enrolled
PPDIndustry Sponsor
159 Previous Clinical Trials
36,846 Total Patients Enrolled
Dorry L. Segev, MD, PhDStudy ChairDepartment of Surgery, Johns Hopkins University School of Medicine
1 Previous Clinical Trials
400 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Annals of Internal MedicineJournal
Safety and Immunogenicity of a Third Dose of Sars-cov-2 Vaccine in Solid Organ Transplant Recipients: A Case Series
Werbel, William A., Brian J. Boyarsky, Michael T. Ou, Allan B. Massie, Aaron A.R. Tobian, Jacqueline M. Garonzik-Wang, and Dorry L. Segev. 2021. “Safety and Immunogenicity of a Third Dose of Sars-cov-2 Vaccine in Solid Organ Transplant Recipients: A Case Series”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/l21-0282.
Annals of Internal MedicineJournal
Safety and Immunogenicity of a Third Dose of Sars-cov-2 Vaccine in Solid Organ Transplant Recipients: A Case Series
Werbel, William A., Brian J. Boyarsky, Michael T. Ou, Allan B. Massie, Aaron A.R. Tobian, Jacqueline M. Garonzik-Wang, and Dorry L. Segev. 2021. “Safety and Immunogenicity of a Third Dose of Sars-cov-2 Vaccine in Solid Organ Transplant Recipients: A Case Series”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/l21-0282.
clinicaltrials.govStudy
COVID-19 Protection After Transplant Pilot Study
2021. "COVID-19 Protection After Transplant Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04969263.
~22 spots leftby Apr 2025
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