HPV Vaccine for Post-Kidney Transplant Recipients
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using any investigational drugs, you would not be eligible to participate.
What data supports the effectiveness of the HPV vaccine treatment for post-kidney transplant recipients?
The HPV vaccine has been shown to prevent HPV infections and reduce precancerous lesions and cervical cancers in individuals with healthy immune systems. Although kidney transplant recipients may have a lower immune response to the vaccine, it is still considered important for preventing HPV-related diseases in this population.12345
Is the HPV vaccine safe for post-kidney transplant recipients?
The HPV vaccine has been generally well-tolerated in kidney transplant recipients, with no significant adverse events reported in studies. However, there was a non-significant increase in acute rejection (AR) episodes among vaccinated kidney transplant recipients, suggesting the need for further research to confirm safety.13678
How is the HPV vaccine treatment unique for post-kidney transplant recipients?
The HPV vaccine is unique for post-kidney transplant recipients because it helps prevent HPV-related cancers, which are more common in these patients due to their weakened immune systems. Unlike other treatments, this vaccine is used as a preventive measure to reduce the risk of developing HPV-related diseases, and it is important to administer it before transplantation to ensure better immune response.12356
What is the purpose of this trial?
This phase II trial studies whether the nonavalent human papillomavirus vaccine given to adults prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. This study will help inform our scientific understanding about vaccine-induced immune responses among immunosuppressed individuals.
Research Team
Marc T Goodman
Principal Investigator
Northwestern University
Eligibility Criteria
Adults aged 18-49 who are candidates for kidney transplant surgery within the next year, have a good performance status (able to carry out daily activities), and can give informed consent. It's open to both genders, but not for those with active cancer, previous HPV vaccination, prior organ transplants, yeast allergies, or certain uncontrolled illnesses. Pregnant or breastfeeding women and those planning pregnancy are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Vaccination
Participants receive the nonavalent HPV vaccine at least 30 days prior to kidney transplant surgery. The second dose is given at least one month after the first dose, and the third dose is given at least five months after the first dose.
Transplantation and Immediate Post-Transplant Monitoring
Participants undergo kidney transplant surgery and are monitored for immediate post-transplant outcomes.
Follow-up
Participants are monitored for vaccine-induced immune responses and safety at 6 and 12 months post-transplant.
Long-term Follow-up
Participants may receive additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series.
Treatment Details
Interventions
- Recombinant Human Papillomavirus Nonavalent Vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor