HPV Vaccine for Post-Kidney Transplant Recipients

Recruiting at 5 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Investigational agents

Disqualifiers: Previous HPV vaccination, Prior transplant, Active malignancy, others

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

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

Compensation: Varies

Number of Visits: 5

52 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 2 3 5 6}

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

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

Candidate for renal transplant, expected to undergo transplant surgery >= 30 days and =< 12 months after enrollment

For potential participants expected to undergo a living donor transplant, one or more donor(s) have been identified and is/are in work-up (even though all work-up status may or may not be complete); a study clinician confirms the living donor transplant is likely to be scheduled within the next twelve months after taking into account donor work-up progress, age and medical status, and institutional policies

Exclusion Criteria

You have had a type of cancer called basal/squamous cell skin cancer in the past.

You are currently taking any experimental medications.

Previous prophylactic HPV vaccination

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

5-6 months

3 visits (in-person)

Transplantation and Immediate Post-Transplant Monitoring

Participants undergo kidney transplant surgery and are monitored for immediate post-transplant outcomes.

1 month

Follow-up

Participants are monitored for vaccine-induced immune responses and safety at 6 and 12 months post-transplant.

12 months

2 visits (in-person)

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.

1 year

Treatment Details

Interventions

• Recombinant Human Papillomavirus Nonavalent Vaccine

Trial Overview The trial is testing if the nonavalent HPV vaccine can help adults build a strong immune response before kidney transplantation and maintain it while on immunosuppressive drugs post-transplant. Participants will receive the vaccine along with biospecimen collection, self-collected HPV samples, and questionnaires.

Participant Groups

Group I: Prevention (Gardasil 9 HPV vaccine) Experimental Treatment 4 Interventions

Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine IM at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Patients are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Patients may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series. Patients also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

The post-licensure safety profile of HPV vaccines Gardasil and Cervarix was evaluated using data from three sources, including VigiBase and VAERS, confirming that the reported adverse events align with existing safety data.

The analysis showed that the safety profiles of both vaccines are consistent with the information provided in their Summary of Product Characteristics (SPC), indicating that they are safe for public use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. Labadie, J.[2015]

A comprehensive analysis of adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) identified 3,112 AEs for Cervarix, 31,606 for Gardasil, and 6,872 for Gardasil 9, highlighting the need for ongoing monitoring of vaccine safety.

The study found 46 unique serious adverse events (SAEs) associated with the HPV vaccines, clustered around behavioral, neurological, immune, nervous, and reproductive systems, indicating that while the vaccines are effective, further research is needed to understand the cause-and-effect relationships of these AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. Zi, W., Yang, Q., Su, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity of Human Papillomavirus Recombinant Vaccine in Children with CKD. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Human papillomavirus infection-related cancer risk for kidney transplant recipients during adult life can be reduced by vaccination during childhood and adolescence. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Human Papillomavirus Vaccination in Male and Female Adolescents Before and After Kidney Transplantation: A Pediatric Nephrology Research Consortium Study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity and Safety of the 9-Valent Human Papillomavirus Vaccine in Solid Organ Transplant Recipients and Adults Infected With Human Immunodeficiency Virus (HIV). [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Human Papillomavirus in Kidney Transplant Recipients. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

Immunogenicity of a prophylactic quadrivalent human papillomavirus L1 virus-like particle vaccine in male and female adolescent transplant recipients. [2015]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. [2015]

8. England pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]