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