Virus Therapy
Janssen Ad26.CoV2.S Vaccine for Kidney Transplant Recipients
Phase 3
Recruiting
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
Hormonal contraception:
Intrauterine device
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up2 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
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.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are using birth control methods that involve hormones.
Select...
You have an intrauterine device (IUD) in place.
Select...
You have a birth control device that releases hormones inside your uterus.
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 moreAwards & 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.
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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
149 Previous Clinical Trials
577,140 Total Patients Enrolled
Mark D Stegall, MDPrincipal Investigator
Mayo ClinicMedia Library
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