Janssen COVID-19 Vaccine Booster for Kidney Transplant Recipients

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byMark Stegall, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Mark Stegall

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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).

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

I am 18 years old or older.

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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

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Treatment Details

Interventions

Janssen Ad26.CoV2.S Vaccine (Virus Therapy)

Trial OverviewThe 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

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.