Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05087849
Other study ID # 21-35086
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 15, 2022
Est. completion date July 1, 2024

Study information

Verified date February 2023
Source University of California, San Francisco
Contact Ayan Kusari, MD
Phone 628-206-4777
Email ayan.kusari@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Biological:
nonavalent human papillomavirus vaccine
Intralesional injection of nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks

Locations

Country Name City State
United States Zuckerberg San Francisco General Hospital San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in wart number between Week 0 (baseline) 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. to be measured at baseline (week 0) and Week 12.
Primary Change in wart number between Week 0 (baseline) and Week 4 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. to be measured at baseline (week 0) and Week 12.
Primary Change in mean size of genital condyloma between Week 0 (baseline) 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. to be measured at baseline (week 0) and Week 4
Primary Change in mean size of genital condyloma between Week 0 (baseline) and Week 12 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. to be measured at baseline (week 0) and Week 4.
Secondary Change in score of Specific Questionnaire for Condylomata Acuminata (CECA) 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. to be measured at baseline (week 0) and week 12
Secondary Change in score of Dermatology quality of life index (DLQI) 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. to be measured at baseline (week 0) and week 12
See also
  Status Clinical Trial Phase
Recruiting NCT05329961 - Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study Early Phase 1
Completed NCT05862844 - Promise Women Project N/A
Active, not recruiting NCT04199078 - Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions. N/A
Recruiting NCT05566106 - Anal Follow-up of Patients With a Gynecological History of High-grade Lesion and More Induced HPV
Not yet recruiting NCT06229353 - Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department
Not yet recruiting NCT06436274 - Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV. Phase 4
Completed NCT01757392 - Candin Safety & Efficacy Study for the Treatment of Warts Phase 2
Active, not recruiting NCT04716127 - A Proximity-incentive Strategy for Cervical Cancer Screening N/A
Recruiting NCT05210348 - Clinical Evaluation of Detection of High Risk HPV in Urine
Recruiting NCT05835947 - Anal Cancer Risk In Women
Not yet recruiting NCT03947775 - HPV-SAVE_Merck_Sub-Study for Preventing Recurrence of HSIL Phase 2
Terminated NCT03404310 - Zinc Sulfate for Human Papillomavirus (HPV) N/A
Recruiting NCT03302858 - A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRXâ„¢ Anorectal Wand Phase 2
Completed NCT03082950 - HPV Infections, Cancer of the Vulva and Therapeutical Success
Active, not recruiting NCT04950101 - Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis N/A
Recruiting NCT05146895 - A Cohort Study of Hyperthermia and Imiquimod for the Treatment of Flat Warts N/A
Completed NCT04002154 - Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV N/A
Recruiting NCT04232917 - Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections. Phase 4
Active, not recruiting NCT03729518 - TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck N/A
Recruiting NCT05640700 - Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia