Intralesional HPV Vaccine for Condylomata

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

Detailed Description
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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.

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

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

Intervention / Treatment
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* Biological: nonavalent human papillomavirus vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intralesional injection of nonavalent human papillomavirus vaccine<br>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<br>* Intralesional injection of nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gardasil 9, nonavalent human papillomavirus vaccine, intralesional immunotherapy, condyloma, genital warts