Trial · NCT00988559

Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)

NCT00988559, Phase 1, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2018-07-09

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3). Trials, record NCT00988559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00988559

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)
NCT number: NCT00988559
Status: Completed
Phases: Phase 1
Enrollment: 132 participants, actual
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions: HPV16 Positive, Cervical Intraepithelial Neoplasia (CIN 2/3)
Interventions: DNA vaccination, Gene gun vaccine, intramuscular vaccination, intra-lesional vaccine administration, therapeutic resection of the lesion, imiquimod
First posted: 2009-10-02
Last updated: 2018-07-09
Results first posted: 2018-07-09

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Related Serious Adverse Events	9 months	Presence of intervention-related serious adverse events as defined by CTCAE
Secondary	Absence of CIN2/3 Lesion by Week 15	15 weeks	Number of participants with no CIN2/3 lesion at the week 15 visit

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Related Serious Adverse Events	9 months	Related Serious Adverse Events	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Absence of CIN2/3 Lesion by Week 15	15 weeks	Number of participants who had no CIN2/3 at the week 15 resection	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Related Serious Adverse Events	PMED Delivery - Groups 1 and 2	0	Participants
Number of Participants With Related Serious Adverse Events	IM Injections - Groups 5 and 6	0	Participants
Number of Participants With Related Serious Adverse Events	Intralesional Delivery - Group 3 and 4	0	Participants
Number of Participants With Related Serious Adverse Events	Intralesional Delivery + Imiquimod - Group 7	0	Participants
Absence of CIN2/3 Lesion by Week 15	PMED Delivery - Groups 1 and 2	2	Participants
Absence of CIN2/3 Lesion by Week 15	IM Injections - Groups 5 and 6	3	Participants
Absence of CIN2/3 Lesion by Week 15	Intralesional Delivery - Group 3 and 4	3	Participants
Absence of CIN2/3 Lesion by Week 15	Intralesional Delivery + Imiquimod - Group 7	1	Participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PMED Delivery - Groups 1 and 2	10
Overall Study	STARTED	IM Injections - Groups 5 and 6	11
Overall Study	STARTED	Intralesional Delivery - Group 3 and 4	11
Overall Study	STARTED	Intralesional Delivery + Imiquimod - Group 7	7
Overall Study	COMPLETED	PMED Delivery - Groups 1 and 2	9
Overall Study	COMPLETED	IM Injections - Groups 5 and 6	9
Overall Study	COMPLETED	Intralesional Delivery - Group 3 and 4	9
Overall Study	COMPLETED	Intralesional Delivery + Imiquimod - Group 7	6
Overall Study	NOT COMPLETED	PMED Delivery - Groups 1 and 2	1
Overall Study	NOT COMPLETED	IM Injections - Groups 5 and 6	2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Injection site reactions	General disorders	PMED Delivery - Groups 1 and 2	8	10	43
other	Injection site reactions	General disorders	IM Injections - Groups 5 and 6	6	11	10
other	Injection site reactions	General disorders	Intralesional Delivery - Group 3 and 4	1	11	1
other	Injection site reactions	General disorders	Intralesional Delivery + Imiquimod - Group 7	0	7	0
other	General pain, fever, malaise/fatigue	General disorders	PMED Delivery - Groups 1 and 2	8	10	44
other	General pain, fever, malaise/fatigue	General disorders	IM Injections - Groups 5 and 6	8	11	38
other	General pain, fever, malaise/fatigue	General disorders	Intralesional Delivery - Group 3 and 4	8	11	41
other	General pain, fever, malaise/fatigue	General disorders	Intralesional Delivery + Imiquimod - Group 7	7	7	37
other	Depression	Psychiatric disorders	PMED Delivery - Groups 1 and 2	1	10	2
other	Depression	Psychiatric disorders	IM Injections - Groups 5 and 6	0	11	0

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PMED Delivery - Groups 1 and 2
Total, all-cause mortality	IM Injections - Groups 5 and 6
Total, all-cause mortality	Intralesional Delivery - Group 3 and 4
Total, all-cause mortality	Intralesional Delivery + Imiquimod - Group 7
Total, other adverse events	PMED Delivery - Groups 1 and 2	10	10
Total, other adverse events	IM Injections - Groups 5 and 6	11	11
Total, other adverse events	Intralesional Delivery - Group 3 and 4	10	11
Total, other adverse events	Intralesional Delivery + Imiquimod - Group 7	7	7
Total, serious adverse events	PMED Delivery - Groups 1 and 2	0	10
Total, serious adverse events	IM Injections - Groups 5 and 6	0	11

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
P50CA098252	SPORE in Cervical Cancer	WU, TZYY-CHOOU; HUH, WARNER KING	JOHNS HOPKINS UNIVERSITY	NATIONAL CANCER INSTITUTE	2003 to 2025	NIH RePORTER
R21CA128232	Therapeutic HPV vaccination for stage IB1 cervical cancer	TRIMBLE, CORNELIA L	JOHNS HOPKINS UNIVERSITY	NATIONAL CANCER INSTITUTE	2008 to 2009	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00988559

GET https://conductscience.org/api/trials/v1/NCT00988559/events?page=2

API reference For AI assistants