Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 80 for:    "Cervix Disease" | "Vaccines"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051516
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Brief Summary:
This randomized 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.

Condition or disease Intervention/treatment Phase
High Grade Anal Canal Squamous Intraepithelial Neoplasia Vulvar High Grade Squamous Intraepithelial Lesion Other: Laboratory Biomarker Analysis Other: Placebo Other: Questionnaire Administration Biological: Recombinant Human Papillomavirus Nonavalent Vaccine Phase 4

Detailed Description:

PRIMARY OBJECTIVES:

I. Test if the recombinant human papillomavirus nonavalent vaccine (9vHPV vaccine) delivered after treatment for high grade squamous intraepithelial lesion (HSIL) reduces the risk of histologically confirmed recurrent neoplastic lesions (HSIL) by 50% in the vaccinated versus (vs.) placebo arms.

II. Evaluate safety of the HPV vaccine in HSIL participants.

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HPV Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia (VIVA) Trial: A Randomized, Double-Blind, Placebo-Controlled Trial
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : December 21, 2021
Estimated Study Completion Date : December 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (recombinant human papillomavirus nonavalent vaccine)
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies

Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
Given IM
Other Names:
  • Gardasil 9
  • Nonavalent HPV VLP Vaccine
  • Recombinant HPV Nonavalent Vaccine
  • Recombinant Human Papillomavirus 9-valent Vaccine

Placebo Comparator: Arm II (placebo)
Patients receive placebo IM at baseline, 2 months, and 6 months.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Placebo
Given IM
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Time to recurrence of anogenital high grade squamous intraepithelial lesion (HSIL) [ Time Frame: Up to month 36 ]
    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.


Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) graded according to the Food and Drug Administration criteria [ Time Frame: Up to month 36 ]
    Will monitor safety by comparing type and frequency of AEs in the two study arms.

  2. Human papillomavirus (HPV) persistence [ Time Frame: Up to month 36 ]
    Will evaluate whether risk of recurrence is more frequent among those with HPV persistence. Persistence will be measured by HPV genotype or HPV16 variant lineage from swab samples collected at months 0, 18, and 36. Will use Cox proportional hazards, but including a time-dependent covariate of HPV persistence by deoxyribonucleic acid detection from swab samples.

  3. HPV antibody level [ Time Frame: Up to month 36 ]
    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.

  4. Frequency of HSIL recurrence [ Time Frame: Up to month 36 ]
    Will compare the rate of recurrence in each arm of the study. Will include all recurrences, not just first recurrences using Poisson regression with a robust variance estimate, comparing the total number of recurrences for each arm over the total follow-up per arm.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   27 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 27- 69 at enrollment
  • Histologically confirmed diagnosis of initial or recurrent anal or vulvar high-grade squamous intraepithelial lesion 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 area and willing to attend up to 7 clinic visits for a 36-month period at the Virology Research Clinic (VRC)
  • Sexually active women of child-bearing potential must be willing to use effective contraception through month 7 of the study
  • If 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051516


Contacts
Layout table for location contacts
Contact: UW Virology Research Clinic 206-520-4340 vrc@uw.edu
Contact: Sarah Taylor 206-667-4493 sataylor@fredhutch.org

Locations
Layout table for location information
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: UW Virology Research Clinic    206-520-4340    vrc@uw.edu   
Contact: Sarah Taylor    206-667-4493    sataylor@fredhutch.org   
Principal Investigator: Anna Wald         
Principal Investigator: Margaret Madeleine         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Anna Wald Fred Hutch/University of Washington Cancer Consortium

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03051516     History of Changes
Other Study ID Numbers: 9790
NCI-2017-00151 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9790 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
R01CA213130 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Squamous Intraepithelial Lesions of the Cervix
Neoplasms
Uterine Cervical Dysplasia
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vaccines
Immunologic Factors
Physiological Effects of Drugs