Injecting HPV vaccine into genital warts
Therapeutic Intralesional Nonavalent HPV Vaccine for Genital Condylomata in Adults: an Open Label Pilot Study
This study is testing if injecting the Gardasil 9 vaccine directly into genital warts can help reduce their size and number in people who have multiple warts.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | adalimumab, guselkumab, ustekinumab, methotrexate, prednisone |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05087849 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of injecting the Gardasil 9 vaccine directly into genital warts to treat condylomata. It is a prospective, open-label, proof-of-concept study involving 10 participants who have at least three genital condylomata. Participants will receive the vaccine at two intervals, 0 and 4 weeks, and will be monitored for changes in wart size and number over an 8-week follow-up period. The study aims to assess whether this intralesional immunotherapy can provide a beneficial effect on the warts.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 and older with a confirmed diagnosis of genital condylomata and at least three warts larger than 3mm.
Not a fit: Patients who do not have genital condylomata or those with fewer than three warts will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new treatment option for patients suffering from genital warts.
How similar studies have performed: While this approach is novel, similar studies using immunotherapy for HPV-related conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California
- Zuckerberg San Francisco General Hospital — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Ayan Kusari, MD — University of California, San Francisco
- Study coordinator: Ayan Kusari, MD
- Email: ayan.kusari@ucsf.edu
- Phone: 628-206-4777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.