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Vaccine

HPV Vaccine for Post-Kidney Transplant Recipients

Phase 2

Waitlist Available

Led By Marc T Goodman

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 and 12 months post-transplant

Awards & highlights

Study Summary

This trial looks at whether a HPV vaccine can help the body build an effective immune response post-kidney transplant when immunosuppressive drugs are given to prevent transplant rejection.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, common reactions to vaccines like Gardasil 9 may include pain at injection site, swelling, redness, headaches, fatigue and nausea. Severe allergic reactions are rare but possible.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ self-collected at baseline (pre-vaccination) and at 6- and 12- months post-vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~self-collected at baseline (pre-vaccination) and at 6- and 12- months post-vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and self-collected at baseline (pre-vaccination) and at 6- and 12- months post-vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Human papillomavirus

Secondary outcome measures

HPV vaccine-type-specific seroconversion rates

Other outcome measures

Cervix Uteri

Probability of seroconversion

Rise in HPV vaccine-type-specific GMT

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (Gardasil 9 HPV vaccine)Experimental Treatment4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HPV Self-Collection

2022

N/A

~20

Biospecimen Collection

2004

Completed Phase 2

~1730

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,101 Total Patients Enrolled

Marc T GoodmanPrincipal InvestigatorNorthwestern University

2 Previous Clinical Trials

88 Total Patients Enrolled

Media Library

Recombinant Human Papillomavirus Nonavalent Vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03036930 — Phase 2

Human Papillomavirus Research Study Groups: Prevention (Gardasil 9 HPV vaccine)

Human Papillomavirus Clinical Trial 2023: Recombinant Human Papillomavirus Nonavalent Vaccine Highlights & Side Effects. Trial Name: NCT03036930 — Phase 2

Recombinant Human Papillomavirus Nonavalent Vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03036930 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be the ideal subjects for this clinical research?

"To qualify for the study, volunteers must have HPV and be between 18-49 years old. At this time, 180 spots are available in total."

Answered by AI

What is the estimated number of participants being recruited to this research study?

"At this moment, enrollment for the clinical trial is on pause. Initially posted in June of 2017 and last edited September 20th 2022; if you are seeking alternative studies, there are 74 trials actively searching for HPV-infected patients and 32 research sites recruiting human papillomavirus nonavalent vaccine recipients."

Answered by AI

Does this trial have an age restriction, and if so, what is it?

"Prospective participants must meet the age criteria of this trial which requires them to be between 18 and 49 years old."

Answered by AI

Can the public trust in the safety of Recombinant Human Papillomavirus Nonavalent Vaccine?

"At Power, we deemed the safety of Recombinant Human Papillomavirus Nonavalent Vaccine to be a 2 due to limited evidence on efficacy but some data attesting to its safety."

Answered by AI

Is this research a pioneering endeavor?

"At present, 32 trials are ongoing for Recombinant Human Papillomavirus Nonavalent Vaccine across 129 cities and countries. The first study of this drug began back in 2002 under the sponsorship of Merck Sharp & Dohme Corp., which included 12167 participants that successfully completed its Phase 3 clinical trial stage. Since then, 817 further investigations have been accomplished."

Answered by AI

How many research locations are actively conducting this trial?

"This research is happening at various hospitals, including the University of Alabama at Birmingham Cancer Center in Birmingham, AL; Mayo Clinic in Rochester, MN; and Cedars Sinai Medical Center in Los Angeles. There are 6 additional medical centres participating as well."

Answered by AI

What precedent has been set by prior studies utilizing Recombinant Human Papillomavirus Nonavalent Vaccine?

"Currently, 32 different clinical trials are underway for Recombinant Human Papillomavirus Nonavalent Vaccine. Of those running studies, 16 have reached Phase 3 of the trial process. While many of these medical trials originate from Bangkok and Chang Wat Nonthaburi, there are also other sites across 244 locations worldwide contributing to this research effort."

Answered by AI

Does this scientific investigation currently have any open enrollment periods?

"At this time, the trial is not enlisting participants. This medical research was first posted on June 23rd 2017 and last updated on September 20th 2022. For those searching for other trials, there are 74 active clinical studies recruiting patients with human papillomavirus infections as well as 32 investigations actively looking for volunteers to test a recombinant version of the nonavalent HPV vaccine."

Answered by AI

What conditions is Recombinant Human Papillomavirus Nonavalent Vaccine most frequently employed to address?

"Recombinant Human Papillomavirus Nonavalent Vaccine is a viable solution to counteract HPV type 58, HPV type 31, and all other strains of human papillomavirus infections."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients

2017. "Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03036930.

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