High Grade Anal Canal Intraepithelial Neoplasia Clinical Trial
Official title:
HPV Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia (VIVA) Trial: A Randomized, Double-Blind, Placebo-Controlled Trial
| Verified date | January 2024 |
| Source | Fred Hutchinson Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 188 |
| Est. completion date | December 31, 2022 |
| Est. primary completion date | December 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 27 Years to 69 Years |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama |
| United States | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Fred Hutchinson Cancer Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Persistent High-risk Infection Among Vaccine Compared With Placebo Recipients | 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. | Up to month 36 | |
| Secondary | Time to Recurrence of Anogenital High Grade Squamous Intraepithelial Lesion (HSIL) | Will compare vaccine and placebo recipients. Will evaluate differences in the hazard of recurrence using Cox proportional hazards in the intention to treat population and the per protocol population. | Up to month 36 | |
| Secondary | Incidence of Adverse Events (AEs) Via Solicited Vaccine Reactogenicity by Arm | Will monitor safety by comparing type and frequency of AEs in the two study arms, graded according to the Food and Drug Administration criteria. Symptoms are reported at least once from any dose. | Up to month 36 | |
| Secondary | HPV Antibody Level | Will evaluate placebo and vaccine recipients separately. Will assess whether presence and amount of HPV antibody, detected at baseline in the placebo arm, is protective against recurrence. For the vaccine arm, will assess whether magnitude of vaccine antibody levels month 1 following the third vaccination in the vaccine arm affects recurrence. | Up to month 36 |