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Virus Therapy
Janssen COVID-19 Vaccine Booster for Kidney Transplant Recipients
Phase 3
Waitlist Available
Led By Mark D Stegall, MD
Research Sponsored by Mark Stegall
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age on the day of consent
Must have a Roche Elecsys® Anti-SARS-CoV-2 S level of <250 U/mL to be eligible for Segment I
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing if one dose of the Janssen vaccine can provide enough immunity for people who have had kidney transplants and have already received two or three doses of another vaccine.
Who is the study for?
This trial is for kidney transplant recipients over 18 who've had two or three doses of an mRNA COVID-19 vaccine and show low immune response. They must not be planning pregnancy, agree to use contraception, and have no history of severe allergies to vaccines or certain medical conditions.Check my eligibility
What is being tested?
The study tests if a Janssen Ad26.CoV2.S vaccine booster enhances immunity in kidney transplant patients previously vaccinated with mRNA vaccines. It also examines the effects of adjusting immunosuppression medications during this process.See study design
What are the potential side effects?
Possible side effects include typical vaccine reactions like soreness at injection site, fever, fatigue, headache, and muscle pain. There's a risk of rare but serious issues such as blood clots (TTS), capillary leak syndrome (CLS), or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My COVID-19 antibody levels are below 250 U/mL.
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It has been over 90 days since I had any organ transplant.
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I have received a kidney transplant, possibly with other organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anti-COVID spike protein antibody after an additional dose with the Janssen Ad26.CoV2.S vaccine in kidney transplant recipients
Secondary outcome measures
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.
Incidence of COVID-19 infection
Response in low-responders to the Janssen Ad26.CoV2.S Vaccine
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Segment IIExperimental Treatment3 Interventions
Segment II: individuals from Segment I who have a spike protein test result less than 250 U/mL 28 days after receiving the Janssen Ad26.CoV2.S vaccine in Segment I. Subjects will be randomized to receive a change or maintain their current immunosuppression medication regimen and then receive an additional Janssen Ad26.CoV2.S vaccine.
Group II: Segment IExperimental Treatment3 Interventions
Segment I: individuals who have a spike protein test result less than 250 U/mL at the screening visit. Subjects will be randomized to receive a change or maintain their current immunosuppression medication regimen and then receive the Janssen Ad26.CoV2.S vaccine.
Group III: Initial RespondersActive Control1 Intervention
Individuals who have received the Pfizer or Moderna vaccines and have high levels of spike antibodies in their blood, will receive standard of care immunosuppressive (IS) medications.
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Who is running the clinical trial?
Mark StegallLead Sponsor
3 Previous Clinical Trials
535 Total Patients Enrolled
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
579,318 Total Patients Enrolled
Mark D Stegall, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to donate blood or bone marrow for 3 months after my last Janssen vaccine dose.I have had capillary leak syndrome in the past.I have had sudden onset of nerve damage.I have not taken COVID-19 prevention drugs that could affect study results.I am 18 years old or older.My COVID-19 antibody levels are below 250 U/mL.I am committed to following the study's requirements and completing all necessary vaccinations and observations.I have had blood clot issues with low platelet counts.It has been over 90 days since I had any organ transplant.I cannot have shots or blood taken from my muscles due to health reasons.I have not and will not receive any live vaccines around the time I get the Janssen shots.I haven't had cancer, except for certain skin cancers or early cervical cancer, in the last year.I have had myocarditis or pericarditis in the past.I have not and will not receive other vaccines 14 days around my Janssen shots.I had a kidney transplant at Mayo Clinic and received my last mRNA vaccine dose over 28 days ago.I haven't received any experimental treatments or COVID-19 convalescent serum recently.I haven't had a fever or serious illness in the last 24 hours.I have received a kidney transplant, possibly with other organs.
Research Study Groups:
This trial has the following groups:- Group 1: Initial Responders
- Group 2: Segment I
- Group 3: Segment II
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the Janssen Ad26.CoV2.S Vaccine have any short-term or long-term side effects?
"Janssen Ad26.CoV2.S Vaccine is currently in Phase 3 of clinical trials. This means that while there is data supporting efficacy, multiple rounds of data also support safety. Power team rates the safety a 3 on a scale of 1 to 3."
Answered by AI
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