Clinical trial NCT05087849: Intralesional HPV Vaccine for Condylomata
Official title: Therapeutic Intralesional Nonavalent HPV Vaccine for Genital Condylomata in Adults: an Open Label Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Human Papilloma Virus
Warts
Warts, Genital
Condyloma
Condylomata Acuminata
Keywords: Gardasil 9
nonavalent human papillomavirus vaccine
intralesional immunotherapy
condyloma
genital warts
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label, single-arm study in which all participants will receive intralesional Gardasil 9 vaccine to their condyloma.
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Change in wart number between Week 0 (baseline) and Week 12
timeFrame: to be measured at baseline (week 0) and Week 12.
measure: Change in wart number between Week 0 (baseline) and Week 4
timeFrame: to be measured at baseline (week 0) and Week 12.
measure: Change in mean size of genital condyloma between Week 0 (baseline) and Week 4
timeFrame: to be measured at baseline (week 0) and Week 4
measure: Change in mean size of genital condyloma between Week 0 (baseline) and Week 12
timeFrame: to be measured at baseline (week 0) and Week 4.
Secondary outcomes:
measure: Change in score of Specific Questionnaire for Condylomata Acuminata (CECA)
timeFrame: to be measured at baseline (week 0) and week 12
measure: Change in score of Dermatology quality of life index (DLQI)
timeFrame: to be measured at baseline (week 0) and week 12
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ayan Kusari, MD
role: PRINCIPAL_INVESTIGATOR
References: