We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intralesional HPV Vaccine for Condylomata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05087849
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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

Condition or disease Intervention/treatment Phase
Human Papilloma Virus Warts Warts, Genital Condyloma Condylomata Acuminata Biological: nonavalent human papillomavirus vaccine Phase 1 Phase 2

Detailed Description:
This is a prospective, open-label, proof-of-concept research study to assess the effectiveness of intralesional nonavalent in the treatment of patients with genital condylomata. The study will be conducted at Zuckerberg San Francisco General Hospital. The planned intervention is to provide 10 subjects with at least 3 genital condylomata with intralesional nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for change in wart size and wart number.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is an open-label, single-arm study in which all participants will receive intralesional Gardasil 9 vaccine to their condyloma.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Intralesional Nonavalent HPV Vaccine for Genital Condylomata in Adults: an Open Label Pilot Study
Actual Study Start Date : April 15, 2022
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines Warts

Arm Intervention/treatment
Experimental: Intralesional injection of nonavalent human papillomavirus vaccine
Single-arm, open-label study. Intervention consists of intralesional injection of nonavalent human papillomavirus vaccine at 0 and 4 weeks.
Biological: nonavalent human papillomavirus vaccine
Intralesional injection of nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks




Primary Outcome Measures :
  1. Change in wart number between Week 0 (baseline) and Week 12 [ Time Frame: to be measured at baseline (week 0) and Week 12. ]
    Number of warts in genital area, as counted by study personnel at study visits. Genital area is defined as (1) suprapubic (2) left inguinal (3) right inguinal (4) vulvar (5) perineal (6) perianal in anatomic females, and as (1) suprapubic (2) left inguinal (3) right inguinal (4) dorsal penile (5) ventral penile and scrotal (6) perineal (7) perianal in anatomic males. Warts will be counted by study personnel at in-person evaluations at week 0, week 4 and week 12.

  2. Change in wart number between Week 0 (baseline) and Week 4 [ Time Frame: to be measured at baseline (week 0) and Week 12. ]
    Number of warts in genital area, as counted by study personnel at study visits. Genital area is defined as (1) suprapubic (2) left inguinal (3) right inguinal (4) vulvar (5) perineal (6) perianal in anatomic females, and as (1) suprapubic (2) left inguinal (3) right inguinal (4) dorsal penile (5) ventral penile and scrotal (6) perineal (7) perianal in anatomic males. Warts will be counted by study personnel at in-person evaluations at week 0, week 4 and week 12.

  3. Change in mean size of genital condyloma between Week 0 (baseline) and Week 4 [ Time Frame: to be measured at baseline (week 0) and Week 4 ]
    Mean size of warts in genital area, as measured by study personnel at study visits. Genital area is defined as (1) suprapubic (2) left inguinal (3) right inguinal (4) vulvar (5) perineal (6) perianal in anatomic females, and as (1) suprapubic (2) left inguinal (3) right inguinal (4) dorsal penile (5) ventral penile and scrotal (6) perineal (7) perianal in anatomic males. Warts will be counted by study personnel at in-person evaluations at week 0, week 4 and week 12.

  4. Change in mean size of genital condyloma between Week 0 (baseline) and Week 12 [ Time Frame: to be measured at baseline (week 0) and Week 4. ]
    Mean size of warts in genital area, as measured by study personnel at study visits. Genital area is defined as (1) suprapubic (2) left inguinal (3) right inguinal (4) vulvar (5) perineal (6) perianal in anatomic females, and as (1) suprapubic (2) left inguinal (3) right inguinal (4) dorsal penile (5) ventral penile and scrotal (6) perineal (7) perianal in anatomic males. Warts will be counted by study personnel at in-person evaluations at week 0, week 4 and week 12.


Secondary Outcome Measures :
  1. Change in score of Specific Questionnaire for Condylomata Acuminata (CECA) [ Time Frame: to be measured at baseline (week 0) and week 12 ]
    Established tool to measure quality of life with respect to condyloma. Will be administered at baseline and week 12 by study personnel. It comprises 10 items and 2 dimensions. The emotional dimension includes 6 items and the sexual activity dimension includes 4 items. The questions refer to the past 7 days. The higher the score the better the quality of life. The global scoring range was 10-50, ranging from 6 to 30 in the emotional dimensions and from 4 to 20 in the sexual activity dimension.

  2. Change in score of Dermatology quality of life index (DLQI) [ Time Frame: to be measured at baseline (week 0) and week 12 ]
    Established tool to measure quality of life with any dermatologic disease. Will be administered at baseline and week 12 by study personnel. Consists of 10 questions scored from 0-3. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of all genders aged ≥ 18 years
  • Signed informed consent form
  • Confirmed clinical diagnosis of genital condylomata with minimum of 3 genital condylomata, each measuring >3mm
  • Individuals who are able to become pregnant will be advised on the following:

All individuals who are able to become pregnant will be asked about their reproductive health, sexual activity (partners, practices, prevention of pregnancy) and be advised that administration of vaccine during pregnancy is not recommended while data collection to monitor pregnancy and infant outcomes following exposure to the papillomavirus (9-valent) vaccine is ongoing. However, based on available data, an increased risk of adverse pregnancy outcomes, specifically miscarriage or congenital anomalies, has not been observed following inadvertent administration of the papillomavirus vaccine during pregnancy. Individuals who are able to become pregnant are advised to contact us immediately and will not receive any further intralesional vaccine.

Exclusion Criteria:

  • 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.
  • 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.
  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05087849


Contacts
Layout table for location contacts
Contact: Ayan Kusari, MD 628-206-4777 ayan.kusari@ucsf.edu
Contact: Kieron Leslie, MD 4153537800 kieron.leslie@ucsf.edu

Locations
Layout table for location information
United States, California
Zuckerberg San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Ayan Kusari, MD    628-206-8680    ayan.kusari@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Ayan Kusari, MD University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05087849    
Other Study ID Numbers: 21-35086
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, San Francisco:
Gardasil 9
nonavalent human papillomavirus vaccine
intralesional immunotherapy
condyloma
genital warts
Additional relevant MeSH terms:
Layout table for MeSH terms
Warts
Condylomata Acuminata
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Infections
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases