NCT03051516 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE4
Status at capture: TERMINATED
Registry last update: 2024-02-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Persistent High-risk Infection Among Vaccine Compared With Placebo Recipients

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

HPV Antibody Level

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
maximum Age: 69 Years
minimum Age: 27 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months.
intervention Names
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
label
Arm I (recombinant human papillomavirus nonavalent vaccine)
type
EXPERIMENTAL
description
Patients receive placebo IM at baseline, 2 months, and 6 months.
intervention Names
Other: Laboratory Biomarker Analysis
Other: Placebo Administration
Other: Questionnaire Administration
label
Arm II (placebo)
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Arm I (recombinant human papillomavirus nonavalent vaccine)
Arm II (placebo)
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER
arm Group Labels
Arm II (placebo)
description
Given IM
name
Placebo Administration
type
OTHER
arm Group Labels
Arm I (recombinant human papillomavirus nonavalent vaccine)
Arm II (placebo)
description
Ancillary studies
name
Questionnaire Administration
type
OTHER
arm Group Labels
Arm I (recombinant human papillomavirus nonavalent vaccine)
description
Given IM
name
Recombinant Human Papillomavirus Nonavalent Vaccine
other Names
Gardasil 9
Nonavalent HPV Vaccine
Recombinant HPV Nonavalent Vaccine
Recombinant Human Papillomavirus 9-valent Vaccine
type
BIOLOGICAL

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: TRIPLE
who Masked: PARTICIPANT
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 188
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Persistent High-risk Infection Among Vaccine Compared With Placebo Recipients
time Frame
Up to month 36

secondary Outcomes

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
Time to Recurrence of Anogenital High Grade Squamous Intraepithelial Lesion (HSIL)
time Frame
Up to month 36
description
Will monitor safety by comparing type and frequency of AEs in the two study arms, graded according to the Food and Drug Administration criteria. Symptoms are reported at least once from any dose.
measure
Incidence of Adverse Events (AEs) Via Solicited Vaccine Reactogenicity by Arm
time Frame
Up to month 36
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.
measure
HPV Antibody Level
time Frame
Up to month 36

Full study description

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.
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.

Source references

references

citation
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
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
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requested nct id
NCT03051516
primary nct id
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source kind
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Vulvar+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
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id
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nct id
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occurrences
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exact text
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start
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offset unit
unicode_code_points
query cond
Vulvar Cancer
query disease state id
ds-vulvar-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-vulvar-cancer-000.json
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source kind
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source record id
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source string basis
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Vulvar+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice