Janssen COVID-19 Vaccine Booster for Kidney Transplant Recipients

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a dose of the Janssen COVID-19 vaccine can boost immune protection in individuals who have had a kidney transplant and previously received two or three doses of the Pfizer or Moderna vaccines. The researchers aim to determine if the Janssen vaccine can enhance the body's response to COVID-19 in these individuals. The study includes different groups based on initial antibody levels and medication changes. Individuals who have had a kidney transplant and received mRNA vaccines might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking advancements in COVID-19 treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get a clear answer based on your specific situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Janssen Ad26.CoV2.S vaccine is generally safe. Safety data indicates that about 97% of reactions after vaccination were not serious, with most people experiencing mild side effects such as a sore arm, fatigue, or mild fever, similar to earlier studies before widespread use.

Researchers are testing this vaccine as a booster for individuals who have had a kidney transplant, a group with special needs. Although the Janssen vaccine is already approved for other groups, this study aims to determine its safety for kidney transplant recipients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Janssen COVID-19 Vaccine Booster for kidney transplant recipients because it offers a tailored approach to boosting immunity in a group that's often more vulnerable to infections. Unlike standard vaccines, which might not elicit a strong response in people with compromised immune systems, this booster is part of a strategy that adjusts according to the individual's antibody levels. For those with low or undetectable spike antibodies, the treatment involves adjusting immunosuppressive medications and providing additional vaccine doses, aiming to optimize the immune response. This personalized strategy could significantly enhance protection against COVID-19 for kidney transplant recipients, making it a promising advancement in their care.

What evidence suggests that the Janssen Ad26.CoV2.S vaccine could be an effective booster for kidney transplant recipients?

Research has shown that the Janssen Ad26.CoV2.S vaccine can enhance the immune system in kidney transplant recipients. In this trial, participants with low antibody levels after receiving the Pfizer or Moderna vaccines will receive the Janssen vaccine to determine if their immune response improves, which is crucial for better protection against COVID-19. Some participants will either maintain or change their immunosuppression medication regimen while receiving the Janssen vaccine to evaluate the impact on antibody levels. Another review found that using the Janssen vaccine alongside mRNA vaccines provided better protection against severe illness and hospital visits. Overall, these findings suggest that the Janssen booster may offer additional benefits for these patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Mark Stegall, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Undetectable Levels (UL) Spike Antibodies: Maintain Immunosuppression Medication Experimental Treatment 2 Interventions

Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to maintain their current immunosuppression medication regimen and then receive a Janssen Ad26.CoV2.S vaccine. 28 days after receiving the first dose of the Janssen Ad26.CoV2.S vaccine, if a subject's spike protein test results were less than 250 U/mL then a second dose of the Janssen Ad26.CoV2.S vaccine was administered. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Maintenance in Immunosuppression Medication: Maintain current immunosuppression medication dosage

Group II: Undetectable Levels (UL) Spike Antibodies: Change Immunosuppression Medication Experimental Treatment 2 Interventions

Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to change their current immunosuppression medication regimen and then receive an additional Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Reduction in Immunosuppression Medication: Reduction in immunosuppression medication dosage

Group III: Low Level (LL) Spike Antibodies: Janssen Vaccine Responders Experimental Treatment 1 Intervention

Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were greater than or equal to 250 U/mL. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle

Group IV: Low Level (LL) Spike Antibodies: Janssen Vaccine Non-Responders Experimental Treatment 1 Intervention

Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were less than 250 U/mL. 28 days following the first dose of the Janssen Ad26.CoV2.S vaccine, subjects were given a second dose of Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle

Group V: Initial Responders Active Control 1 Intervention

Individuals who have previously 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+

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05220397

Janssen Ad26.CoV2.S Vaccine Booster in Kidney ... 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).

2. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(25)00168-5/fulltext

Responses of Kidney Transplant Recipients to Vaccination ... Objective. To assess heterologous booster (HB) with Janssen Ad26.COV2.S in kidney transplant recipients (KTRs) with low antibody levels after ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0025619625001685

Responses of Kidney Transplant Recipients to Vaccination ... This prospective, open-label, randomized trial evaluated the ability of HB with Janssen Ad26.COV2.S vaccine (NCT05220397 ) to increase anti–spike protein ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9992272/

vaccines, timing of transplant after COVID-19 infection and ... CONCLUSION. Vaccination against SARS-CoV-2 is effective in reducing the risk of severe disease and death among transplant patients. Unfortunately, humoral and, ...

5. cdc.gov cdc.gov/mmwr/volumes/71/wr/mm7113e2.htm

Effectiveness of Homologous and Heterologous COVID-19 ... Vaccination with 1 Janssen/1 mRNA dose provided higher protection than did 2 Janssen doses against COVID-19–associated ED/UC visits and was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8259673/

SARS-CoV-2 Vaccines in Kidney Transplant Recipients We provide an overview of SARS-CoV-2 vaccines and highlight key concepts that should be considered in evaluating their safety in solid organ transplant ...

7. cdc.gov cdc.gov/mmwr/volumes/70/wr/mm7018e2.htm

Safety Monitoring of the Janssen (Johnson & ... Review of safety monitoring data found that 97% of reported reactions after vaccine receipt were nonserious, consistent with preauthorization clinical trials ...