Therapeutic Intralesional Nonavalent HPV Vaccine for Genital Condylomata in Adults: an Open Label Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Wart Number
研究概览
简要总结
This study will investigate whether injecting genital warts with small quantities of the Gardasil 9 vaccine has an effect on the warts.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: nonavalent human papillomavirus vaccine (Biological)
结局指标
主要结局
Change in Wart Number
时间窗: Baseline (week 0) and Week 12.
Change in number of warts in genital area.
Change in Average Size of Genital Warts in mm
时间窗: 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 .
次要结局
- Change in Score of Specific Questionnaire for Condylomata Acuminata (CECA)(to be measured at baseline (week 0) and week 12)
- Change in Score of Dermatology Quality of Life Index (DLQI)(to be measured at baseline (week 0) and week 12)