HPV Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia (VIVA) Trial: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 188
- 试验地点
- 4
- 主要终点
- Persistent High-risk Infection Among Vaccine Compared With Placebo Recipients
研究概览
简要总结
This phase IV trial studies how well human papillomavirus (HPV) vaccine therapy works in interrupting progression in patients with high-grade vulvar or anal lesions. Vaccines made from HPV peptides or antigens may help the body build an effective immune response to kill tumor cells and decrease the chance of vulvar or anal lesions to progress or come back.
详细描述
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline, 2 months, and 6 months.
ARM II: Patients receive placebo IM at baseline, 2 months, and 6 months.
After completion of study treatment, patients are followed up at months 7, 12, 18, 24, 36, and 42.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 27 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of initial or recurrent anal or vulvar high-grade squamous intraepithelial lesion (AIN2/3 or VIN2/3) diagnosed on or after 1/1/2014; study pathologist will use p16 staining as needed to rule out low-grade squamous intraepithelial lesion (LSIL) disease
- •>= 2 months since last therapy for HSIL
- •No clinical evidence of HSIL on screening examination; if HSIL is suspected, a biopsy will be done to exclude HSIL; patients whose screening visit reveals HSIL on biopsy, may be re-screened >= 2 months after therapy
- •Resident in the catchment area of the clinics and willing to attend up to 8 clinic visits for a 36-month period
- •Sexually active women of child-bearing potential must be willing to use effective contraception through month 7 of the study
- •If human immunodeficiency virus (HIV) positive, receipt of anti-retroviral therapy continuously for at least 6 months prior to enrollment
- •Ability to give informed consent
- •Willingness to sign medical records release form and tissue release form
排除标准
- •Currently pregnant
- •Chemotherapy (current, within the last month, or anticipated in the next 7 months)
- •Prior history of invasive HPV-related anogenital cancer (cervical, vaginal, vulvar, penile, or anal cancer), or oropharyngeal cancer (base of tongue, tonsil); prior cancer at other sites (including most of oral cavity) or larynx are not exclusions
- •Unstable medical condition (e.g., another malignancy requiring treatment, malignant hypertension, poorly controlled diabetes, another cancer except for fully excised non-melanoma skin cancer)
- •Prior HPV vaccination
- •Known allergy or intolerance to lidocaine
- •Currently participating in an interventional research study related to HPV, except the Anal Cancer HSIL Outcomes Research (ANCHOR) study (NCT02135419)
- •Any other condition which, in the opinion of the investigator, may compromise the subject's ability to follow study procedures and safely complete the study
结局指标
主要结局
Persistent High-risk Infection Among Vaccine Compared With Placebo Recipients
时间窗: Up to month 36
Persistence will be measured as two or more consecutive polymerase chain reaction (PCR) positive swabs for the same human papillomavirus (HPV) genotype. Will use Chi-Square test to compare the number of participants with the persistent infection in the vaccinated to unvaccinated group.
次要结局
- Time to Recurrence of Anogenital High Grade Squamous Intraepithelial Lesion (HSIL)(Up to month 36)
- HPV Antibody Level(Up to month 36)
- Incidence of Adverse Events (AEs) Via Solicited Vaccine Reactogenicity by Arm(Up to month 36)
研究者
Margaret M. Madeleine, PhD
Professor
Fred Hutchinson Cancer Center