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

NCT03051516 | Terminated Phase 4 Results DMC FDA Drug

• 4 other identifiers: 9790NCI-2017-00151R01CA213130RG1001522
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to Recurrence of Anogenital High Grade Squamous Intraepithelial Lesion (HSIL)

  Up to month 36

• Incidence of Adverse Events (AEs) Via Solicited Vaccine Reactogenicity by Arm

  Up to month 36

• HPV Antibody Level

  Up to month 36

Study Arms (2)

Arm I (recombinant human papillomavirus nonavalent vaccine)

EXPERIMENTAL

Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months.

Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo IM at baseline, 2 months, and 6 months.

Other: Laboratory Biomarker Analysis; Other: Placebo Administration; Other: Questionnaire Administration

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (recombinant human papillomavirus nonavalent vaccine); Arm II (placebo)

Placebo Administration OTHER

Given IM

Arm II (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (recombinant human papillomavirus nonavalent vaccine); Arm II (placebo)

Recombinant Human Papillomavirus Nonavalent Vaccine BIOLOGICAL

Given IM

Also known as: Gardasil 9, Nonavalent HPV Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine

Arm I (recombinant human papillomavirus nonavalent vaccine)

Eligibility Criteria

• Age: 27 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Currently pregnant
• Chemotherapy (current, within the last month, or anticipated in the next 7 months)
• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Stankiewicz Karita HC, Hauge K, Magaret A, Mao C, Schouten J, Grieco V, Xi LF, Galloway DA, Madeleine MM, Wald A. Effect of Human Papillomavirus Vaccine to Interrupt Recurrence of Vulvar and Anal Neoplasia (VIVA): A Trial Protocol. JAMA Netw Open. 2019 Apr 5;2(4):e190819. doi: 10.1001/jamanetworkopen.2019.0819.

  PMID: 30977845 DERIVED

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Limitations and Caveats

An interim analysis found the intervention to be futile. Therefore, the VIVA trial was ended effective July 31st, 2022, for the University of Washington clinic, and December 31st, 2022, for the University of Alabama Birmingham clinic. Participants were offered the choice of continuing any outstanding visits until the end of the study at the respective sites.

Results Point of Contact

• Title: Margaret M. Madeleine, PhD
• Organization: Fred Hutchinson Cancer Center

mmadelei@fredhutch.org

206-667-4630

Study Officials

• Anna Wald

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Study Start: August 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)