RECRUITING

Intralesional HPV Vaccine for Condylomata

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Conditions

Human Papilloma VirusWartsWarts, GenitalCondylomaCondylomata AcuminataGardasil 9nonavalent human papillomavirus vaccineintralesional immunotherapygenital warts

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will investigate whether injecting genital warts with small quantities of the Gardasil 9 vaccine has an effect on the warts.

Official Title

Therapeutic Intralesional Nonavalent HPV Vaccine for Genital Condylomata in Adults: an Open Label Pilot Study

Quick Facts

Study Start:2022-04-15
Study Completion:2024-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05087849

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients of all genders aged ≥ 18 years
  2. * Signed informed consent form
  3. * Confirmed clinical diagnosis of genital condylomata with minimum of 3 genital condylomata, each measuring \>3mm
  4. * Individuals who are able to become pregnant will be advised on the following:
  1. * Participants will be asked about pregnancy at time of recruitments. Individuals who are pregnant or are planning to become pregnant will not be permitted to participate in the study, as ACOG does not recommend Gardasil 9 during pregnancy. Participants will be encouraged not to participate in the study if they believe they may become pregnant during the study.
  2. * Participants will be asked about allergic reaction to yeast and vaccine components at time of recruitment. Subjects with severe allergic reactions to baker's yeast (Saccharomyces cerevisiae, a vaccine component), or other vaccine components (ie polysorbate 80, Merck amorphous aluminum hydroxyphosphate sulfate) will not be permitted to participate in this study.
  3. * Participants' vaccination history will be reviewed at time of recruitment. Patients who have previously received any prior human papillomavirus vaccine will not be permitted to participate in this study.
  4. * Subjects' medical history and current medications will be reviewed at time of recruitment. Subjects taking immune suppressive medications (steroids such as prednisone or dexamethasone, immunosuppressive agents such as methotrexate, azathioprine, cyclosporine, immunomodulatory agents such as apremilast, or immunomodulatory biologic agents such as adalimumab, guselkumab or ustekinumab) will be excluded. Subjects with medical conditions that significantly alter the immune system, such as known HIV infection, leukemia or lymphoma will be excluded from this pilot study.

Contacts and Locations

Study Contact

Ayan Kusari, MD
CONTACT
628-206-4777
ayan.kusari@ucsf.edu
Kieron Leslie, MD
CONTACT
4153537800
kieron.leslie@ucsf.edu

Principal Investigator

Ayan Kusari, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Ayan Kusari, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-15
Study Completion Date2024-07-01

Study Record Updates

Study Start Date2022-04-15
Study Completion Date2024-07-01

Terms related to this study

Keywords Provided by Researchers

  • Gardasil 9
  • nonavalent human papillomavirus vaccine
  • intralesional immunotherapy
  • condyloma
  • genital warts

Additional Relevant MeSH Terms

  • Human Papilloma Virus
  • Warts
  • Warts, Genital
  • Condyloma
  • Condylomata Acuminata