NCT03051516 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Participants were included in this analysis if they had 2 or more HPV DNA PCR results from swabs collected after the baseline swab. Of the 185 participants in the baseline population, 117 were included in this analysis.

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secondary · POSTED

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.

Source null

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secondary · POSTED

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.

There were 173 incidence of reported symptoms among participants in Arm I (Vaccine) and 127 incidence of reported symptoms among participants in Arm II (Placebo). Overall, there were 91 participants in Arm I (Vaccine) and 94 participants in Arm II (Placebo) reported symptoms at least once for any dose received.

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secondary · POSTED

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.

Participants with usable serology samples from at least one timepoint are included in this analysis.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-squamous-cell-neoplasm
nct id: NCT03051516
trial label: HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
outcome key
om-0000
source section id
NCT03051516-om-0000
source outcome index
0
endpoint
Persistent High-risk Infection Among Vaccine Compared With Placebo Recipients
endpoint definition
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.
time origin
Up to month 36
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants were included in this analysis if they had 2 or more HPV DNA PCR results from swabs collected after the baseline swab. Of the 185 participants in the baseline population, 117 were included in this analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
outcome key
om-0001
source section id
NCT03051516-om-0001
source outcome index
1
endpoint
Time to Recurrence of Anogenital High Grade Squamous Intraepithelial Lesion (HSIL)
endpoint definition
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.
time origin
Up to month 36
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
outcome key
om-0002
source section id
NCT03051516-om-0002
source outcome index
2
endpoint
Incidence of Adverse Events (AEs) Via Solicited Vaccine Reactogenicity by Arm
endpoint definition
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.
time origin
Up to month 36
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
There were 173 incidence of reported symptoms among participants in Arm I (Vaccine) and 127 incidence of reported symptoms among participants in Arm II (Placebo). Overall, there were 91 participants in Arm I (Vaccine) and 94 participants in Arm II (Placebo) reported symptoms at least once for any dose received.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
outcome key
om-0003
source section id
NCT03051516-om-0003
source outcome index
3
endpoint
HPV Antibody Level
endpoint definition
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.
time origin
Up to month 36
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants with usable serology samples from at least one timepoint are included in this analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
outcome key
om-0000
arm key
OG000
arm label
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)
regimen
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
analyzed count
53
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03051516-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
outcome key
om-0000
arm key
OG001
arm label
Arm II (Placebo)
regimen
Patients receive placebo IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given IM Questionnaire Administration: Ancillary studies
analyzed count
64
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03051516-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
outcome key
om-0001
arm key
OG000
arm label
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)
regimen
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
analyzed count
91
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03051516-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
outcome key
om-0001
arm key
OG001
arm label
Arm II (Placebo)
regimen
Patients receive placebo IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given IM Questionnaire Administration: Ancillary studies
analyzed count
94
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03051516-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
outcome key
om-0002
arm key
OG000
arm label
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)
regimen
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
analyzed count
91
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03051516-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
outcome key
om-0002
arm key
OG001
arm label
Arm II (Placebo)
regimen
Patients receive placebo IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given IM Questionnaire Administration: Ancillary studies
analyzed count
94
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03051516-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
outcome key
om-0003
arm key
OG000
arm label
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)
regimen
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
analyzed count
68
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03051516-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
outcome key
om-0003
arm key
OG001
arm label
Arm II (Placebo)
regimen
Patients receive placebo IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given IM Questionnaire Administration: Ancillary studies
analyzed count
80
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03051516-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
harm key
EG000
source section id
NCT03051516-ae
event group key
EG000
event group label
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)
serious affected
19
serious at risk
91
other affected
60
other at risk
91
frequency threshold
0
collection period
42 months, from enrollment visit (Month 0) to final follow-up at Month 42.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03051516
harm key
EG001
source section id
NCT03051516-ae
event group key
EG001
event group label
Arm II (Placebo)
serious affected
16
serious at risk
94
other affected
58
other at risk
94
frequency threshold
0
collection period
42 months, from enrollment visit (Month 0) to final follow-up at Month 42.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice