Trials / Terminated
TerminatedNCT03051516
HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions
HPV Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia (VIVA) Trial: A Randomized, Double-Blind, Placebo-Controlled Trial
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 188 (actual)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 27 Years – 69 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| OTHER | Placebo Administration | Given IM |
| OTHER | Questionnaire Administration | Ancillary studies |
| BIOLOGICAL | Recombinant Human Papillomavirus Nonavalent Vaccine | Given IM |
Timeline
- Start date
- 2017-08-01
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2017-02-13
- Last updated
- 2024-02-28
- Results posted
- 2024-02-28
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03051516. Inclusion in this directory is not an endorsement.