← Back to Search

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

Must not have

History of capillary leak syndrome (CLS)

History of acute polyneuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

Select...

I am 18 years old or older.

Select...

My COVID-19 antibody levels are below 250 U/mL.

Select...

It has been over 90 days since I had any organ transplant.

Select...

I have received a kidney transplant, possibly with other organs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had capillary leak syndrome in the past.

Select...

I have had sudden onset of nerve damage.

Select...

I have not taken COVID-19 prevention drugs that could affect study results.

Select...

I have had blood clot issues with low platelet counts.

Select...

I cannot have shots or blood taken from my muscles due to health reasons.

Select...

I have had myocarditis or pericarditis in the past.

Select...

I haven't had a fever or serious illness in the last 24 hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Anti-COVID spike protein antibody after an additional dose with the Janssen Ad26.CoV2.S vaccine in kidney transplant recipients

Secondary study objectives

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 more

Awards & Highlights

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.

Trial 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.

0 / 11Eligibility criteria met