Condyloma, Condylomata Acuminata, Human Papilloma Virus, Warts, Warts, Genital
Conditions
Keywords
Gardasil 9, nonavalent human papillomavirus vaccine, intralesional immunotherapy, condyloma, genital warts
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.
Interventions
BIOLOGICALnonavalent human papillomavirus vaccine
Intralesional injection of nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label, single-arm study in which all participants will receive intralesional Gardasil 9 vaccine to their condyloma.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wart Number | Baseline (week 0) and Week 12. | Change in number of warts in genital area. |
| Change in Average Size of Genital Warts in mm | to be measured at baseline (week 0) and Week 12 | Mean size of warts in genital area, as measured by study personnel at study visits . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Score of Specific Questionnaire for Condylomata Acuminata (CECA) | 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. |
| Change in Score of Dermatology Quality of Life Index (DLQI) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
nonavalent human papillomavirus vaccine: Intralesional injection of nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Intralesional Injection of Nonavalent Human Papillomavirus Vaccine | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 2 Participants | — |
| Age, Continuous | 38.5 years STANDARD_DEVIATION 3.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 2 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Change in Average Size of Genital Warts in mm
Mean size of warts in genital area, as measured by study personnel at study visits .
Time frame: to be measured at baseline (week 0) and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Change in Average Size of Genital Warts in mm | 0.13 mm | Standard Deviation 0.65 |
Primary
Change in Wart Number
Change in number of warts in genital area.
Time frame: Baseline (week 0) and Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Change in Wart Number | 0.5 warts | Standard Deviation 0.5 |
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.
Time frame: to be measured at baseline (week 0) and week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Change in Score of Dermatology Quality of Life Index (DLQI) | 0 DLQI score | Standard Deviation 2 |
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.
Time frame: to be measured at baseline (week 0) and week 12
Population: All subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Change in Score of Specific Questionnaire for Condylomata Acuminata (CECA) | -18.5 CECA score | Standard Deviation 1.5 |