Clinical trial · Interventional
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
NCT03051516CI-TRIAL-00074523terminatedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated early due to futility.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Anal Canal Intraepithelial Neoplasia | High Grade Anal Canal Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| High Grade Vulvar Squamous Intraepithelial Lesion | High Grade Vulvar Squamous Intraepithelial Lesion | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Placebo Administration | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Recombinant Human Papillomavirus Nonavalent Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (recombinant human papillomavirus nonavalent vaccine)
- description
- Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Questionnaire Administration
- Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo IM at baseline, 2 months, and 6 months.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Placebo Administration
- Other: Questionnaire Administration
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 27 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDStankiewicz 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