HPV Vaccine for Post-Kidney Transplant Recipients

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vaccine for human papillomavirus (HPV) to determine if it helps kidney transplant patients build a strong immune response while on medication to prevent organ rejection. The focus is on whether the vaccine remains effective when patients take immunosuppressive drugs post-transplant. Ideal participants are adults planning to undergo a kidney transplant within the next year. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the HPV vaccine, Gardasil 9, is generally safe. The Centers for Disease Control and Prevention (CDC) confirms that HPV vaccines, including Gardasil 9, have a strong safety record. Most people experience mild side effects, such as soreness at the injection site, dizziness, or headaches. Serious side effects are rare. Some individuals might faint after receiving the shot, a reaction that can occur with any vaccine, especially in teenagers. Overall, the Gardasil 9 vaccine is well-tolerated, and its safety is well-documented. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The HPV vaccine for post-kidney transplant recipients is unique because it specifically targets the prevention of human papillomavirus infections in individuals who have undergone kidney transplants. Unlike typical post-transplant care, which often focuses on managing immunosuppression and preventing organ rejection, this vaccine aims to boost the immune system's ability to fight off HPV, a virus that can lead to serious complications in immunocompromised patients. Researchers are excited about this treatment because it offers a proactive approach to infection prevention, potentially reducing the risk of HPV-related diseases in a vulnerable population. Additionally, the vaccine’s schedule is tailored to fit around the timing of the kidney transplant surgery, ensuring patients can receive the full benefit of immunization while managing their transplant care.

What evidence suggests that this vaccine might be an effective treatment for post-kidney transplant recipients?

Studies have shown that the nonavalent HPV vaccine, known as Gardasil 9, can help prevent cancers caused by HPV. This is particularly important for kidney transplant recipients, who face a higher risk of these cancers due to the drugs used to prevent organ rejection. In this trial, participants will receive the Gardasil 9 vaccine to evaluate its effectiveness in building and maintaining a strong immune response, even in those with weakened immune systems. Research has demonstrated that the vaccine is both safe and effective for individuals with compromised immune systems, such as transplant patients. Overall, the vaccine offers strong protection against HPV-related health issues for those undergoing organ transplants. ^{1 4 6 7 8}

Who Is on the Research Team?

Marc T Goodman

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03036930

Preventive Human Papillomavirus (HPV) Vaccine Trial in ... This phase II trial studies whether the nonavalent human papillomavirus vaccine given to adults prior to kidney transplantation can help the body build and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6817653/

Is there evidence for efficacy of human papillomavirus ... Several studies show an increased risk of HPV-associated cancers in solid organ transplant recipients (SOTR). The aims of this review are to ...

3. withpower.com withpower.com/trial/phase-3-papillomavirus-infections-5-2017-a0ca6

HPV Vaccine for Post-Kidney Transplant Recipients 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 ...

4. lidsen.com lidsen.com/journals/transplantation/transplantation-02-03-017

Acceptance of HPV Vaccination in Kidney Transplant ... The nonavalent HPV vaccine (Gardasil 9) affords transplant recipients the best opportunity for malignancy prevention, but vaccine uptake remains low. Not ...

5. ecdc.europa.eu ecdc.europa.eu/sites/default/files/documents/systematic-review-HPV-vaccination-non-HIV-immunocompromised-individuals-August-2025.pdf

A systematic review and meta-analyses of the efficacy ... - ECDC A systematic review and meta-analyses of the efficacy, effectiveness, immunogenicity and safety of HPV vaccination in non-HIV immunocompromised individuals.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9749905/

Human papillomavirus infection-related cancer risk for ... For HPV vaccine administration in KT recipients it is recommended to wait 3–6 months after transplant, similar to other non-live vaccines except ...

7. cdc.gov cdc.gov/vaccine-safety/vaccines/hpv.html

Human Papillomavirus (HPV) Vaccine Safety A closer look at the safety data · HPV vaccines are safe · Gardasil 9, Gardasil and Cervarix · Fainting and anaphylaxis · Guillain-Barré syndrome (GBS) · Postural ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/petr.14476

Immunogenicity of a quadrivalent human papillomavirus ... Solid-organ transplant recipients are at increased risk of developing human papillomavirus-related diseases.