Clinical Trials /

HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions

NCT03051516

Description:

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.

Related Conditions:
  • Anal Neoplasm
  • Vulvar Squamous Neoplasm
Recruiting Status:

Recruiting

Phase:

Phase 4

URL:

https://clinicaltrials.gov/show/NCT03051516

Trial Eligibility

Document

Title

  • Brief Title: HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions
  • Official Title: HPV Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia (VIVA) Trial: A Randomized, Double-Blind, Placebo-Controlled Trial

Clinical Trial IDs

  • ORG STUDY ID: 9790
  • SECONDARY ID: NCI-2017-00151
  • SECONDARY ID: 9790
  • SECONDARY ID: P30CA015704
  • SECONDARY ID: R01CA213130
  • SECONDARY ID: RG1001522
  • NCT ID: NCT03051516

Conditions

  • High Grade Anal Canal Intraepithelial Neoplasia
  • Vulvar High Grade Squamous Intraepithelial Lesion

Interventions

DrugSynonymsArms
Recombinant Human Papillomavirus Nonavalent VaccineGardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent VaccineArm I (recombinant human papillomavirus nonavalent vaccine)

Purpose

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.

Detailed Description

      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.

Trial Arms

NameTypeDescriptionInterventions
Arm I (recombinant human papillomavirus nonavalent vaccine)ExperimentalPatients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months.
  • Recombinant Human Papillomavirus Nonavalent Vaccine
Arm II (placebo)Placebo ComparatorPatients receive placebo IM at baseline, 2 months, and 6 months.

    Eligibility Criteria

            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
    Maximum Eligible Age:69 Years
    Minimum Eligible Age:27 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Time to persistent high-risk infection among vaccine compared with placebo recipients
    Time Frame:Up to month 36
    Safety Issue:
    Description:Persistence will be measured as two or more consecutive polymerase chain reaction positive swabs for the same human papillomavirus (HPV) genotype. Will use Cox proportional hazards to compare time start of interval for the persistent infection in the vaccinated to unvaccinated group.

    Secondary Outcome Measures

    Measure:Time to recurrence of anogenital high grade squamous intraepithelial lesion (HSIL)
    Time Frame:Up to month 36
    Safety Issue:
    Description: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.
    Measure:Incidence of adverse events (AEs) graded according to the Food and Drug Administration criteria
    Time Frame:Up to month 36
    Safety Issue:
    Description:Will monitor safety by comparing type and frequency of AEs in the two study arms.
    Measure:HPV antibody level
    Time Frame:Up to month 36
    Safety Issue:
    Description: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.

    Details

    Phase:Phase 4
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Fred Hutchinson Cancer Research Center

    Last Updated

    May 14, 2021