Intralesional HPV Vaccine for Condylomata

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Oct 8, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring whether injecting a small amount of the Gardasil 9 vaccine directly into genital warts can help treat them. The study aims to see if this method is effective for people who have at least three genital warts that are larger than 3 millimeters. The trial is open to individuals of all genders who are 18 years or older and have signed a consent form. However, if someone is pregnant or planning to become pregnant, they cannot participate, as the vaccine is not recommended during pregnancy.

Participants in this study can expect to receive injections of the vaccine and will be monitored for any effects. It's important to note that those with certain allergies, previous vaccinations for HPV, or conditions that weaken the immune system will not be eligible to join the study. If you think you might be interested in participating, please reach out for more information, especially if you have questions about your health or any concerns regarding pregnancy.

Gender

ALL

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.