Janssen COVID-19 Vaccine Booster for Kidney Transplant Recipients

Recruiting at 2 trial locations

Overseen By Maria Xiong

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Mark Stegall

Must not be taking: Live vaccines, Investigational drugs

Disqualifiers: Pregnancy, Cancer, Myocarditis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

468 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Mark Stegall, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I agree not to donate blood or bone marrow for 3 months after my last Janssen vaccine dose.

Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies

Negative highly sensitive serum pregnancy test prior to vaccination

Exclusion Criteria

Received an investigational drug within 30 days or used an invasive investigational medical device within 30 days of the Janssen Ad26.CoV2.S vaccine

Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients

Major psychiatric illness that would compromise the participant's safety or compliance with the study procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment - Segment I

Participants with spike protein test result less than 250 U/mL receive the Janssen Ad26.CoV2.S vaccine

4 weeks

1 visit (in-person)

Treatment - Segment II

Participants from Segment I with spike protein test result less than 250 U/mL after 28 days receive an additional Janssen Ad26.CoV2.S vaccine

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Periodic visits (in-person and virtual)

Treatment Details

Interventions

• Janssen Ad26.CoV2.S Vaccine

Trial Overview 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.

Participant Groups

Group I: Segment II Experimental Treatment 3 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 I Experimental Treatment 3 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 Responders Active Control 1 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.

Who Is Running the Clinical Trial?

Mark Stegall

Lead Sponsor

Trials

4

Recruited

1,700+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD