The purpose of this research is to see if a dose of the Janssen Ad26.CoV2.S vaccine effects the immune protection in individuals who have had a kidney transplant and two or three doses of mRNA vaccine (Pfizer and/or Moderna vaccines).
Early after receiving an messenger ribonucleic acid (mRNA) COVID-19 vaccination, most of the general population achieves an anti-COVID spike protein antibody \>250 U/ml. A large percentage of transplant patients form no anti-COVID spike protein antibody or have levels \<250U/ml even early after vaccination. While a direct correlation between any specific anti-COVID spike protein antibody has not been studied extensively, transplant patients do appear to have higher rates of COVID infections and possibly higher mortality rates. Thus, 250 U/ml (the saturation level of the assay below which does not require dilutions) is the target level of anti-COVID spike protein antibody, as that will be considered a "normal" response to the vaccine in this clinical trial. There is no data for intermediate levels of antibody (likely the higher the better the protection). In the absence of any intermediate level data, this study aims to achieve a normal response in transplant recipients receiving the Janssen Ad26.COV2.S vaccine. This study is a phase III, prospective, open label clinical trial with one randomized arm. Its goal is to meet the unmet clinical need to provide vaccine induced immunity for immunocompromised kidney transplant patients after receiving two or three doses of the Pfizer or Moderna COVID-19 vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
468
Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle
Reduction in immunosuppression medication dosage
Maintain current immunosuppression medication dosage
Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Response to the Janssen Ad26.CoV2.S Vaccine in Subjects With Low Level Anti-COVID Spike Protein at Enrollment
Number of patients with initial anti-COVID spike protein antibody levels \>0 but \<250U/ml at enrollment who receive the Janssen Ad26.CoV2.S vaccine who develop anti-COVID spike protein antibody levels greater than or equal to 250 U/mL at 28 days.
Time frame: 28 days following first dose of Janssen Ad26.CoV2.S vaccine
Response to the Janssen Ad26.CoV2.S Vaccine in Subjects With Undetectable Anti-COVID Spike Protein at Enrollment
Number of patients with undetectable anti-COVID spike protein antibody level at enrollment who receive the Janssen Ad26.CoV2.S vaccine who develop anti-COVID spike protein antibody levels greater than or equal to 250 U/mL at 28 days.
Time frame: 28 days following first dose of Janssen Ad26.CoV2.S vaccine
Response to the Janssen Ad26.CoV2.S Vaccine in Subjects Who Had Low or Undetectable Levels of Anti-COVID Spike Protein After the First Dose of the Janssen Vaccine
Number of subjects to achieve an anti-COVID spike protein antibody level greater than or equal to 250 U/mL 28 days after a second dose with the Janssen Ad26.CoV2.S vaccine.
Time frame: 28 days after second dose of Janssen Ad26.CoV2.S vaccine, up to 2 months
Durability of Anti-COVID Spike Protein Antibody Levels in Patients Who Developed Any Level of Antibody Response After Receiving the Janssen Ad26.CoV2.S Vaccine.
As measured by antibody levels from anti-COVID spike protein antibody tests.
Time frame: 2 years
Incidence of COVID-19 Infection
Number of subject infected with COVID-19 after enrollment. Criteria for suspected COVID includes: positive reverse transcription-polymerase chain reaction (RT-PCR) result for SARS-CoV-2 OR New onset or worsening of any one of the following symptoms, which lasts for at least 24 hours, not otherwise explained: headache, malaise, myalgia, chest congestion, cough, runny nose, shortness of breath or difficulty breathing (resting or on exertion), sore throat, wheezing, eye irritation or discharge, chills, fever (≥ 38.0°C or ≥ 100.4°F), pulse oximetry value ≤95% (which is a decrease from baseline), heart rate ≥90 bpm at rest (which is an increase from baseline), GI symptoms, neurologic symptoms, red or bruised looking toes, skin rash, taste loss or new/changing sense of smell, symptoms of blood clots, confusion, bluish lips or face, clinical suspicion or judgement by sponsor-investigator of symptoms suggestive for COVID-19.
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Time frame: 2 years