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

NCT00988559 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2018-07-09

Study results available
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Summary

This study will test the efficacy and safety of different routes of administration of a DNA vaccine in patients with HPV16+ CIN2/3. Subjects will be enrolled in one of six treatment groups. Subjects enrolled in the first two groups will receive vaccination intradermally with a needle-free delivery device. Subjects enrolled in groups 3 and 4 will receive vaccination intramuscularly. Subjects enrolled in groups 5 and 6 will receive vaccine intralesionally.

Conditions

  • HPV16 Positive
  • Cervical Intraepithelial Neoplasia (CIN 2/3)

Interventions

BIOLOGICAL

DNA vaccination

vaccination with pNGVL4a-CRT/E7(detox)

DEVICE

Gene gun vaccine

8 micrograms (group 1) or 16 micrograms (group 2)

BIOLOGICAL

intramuscular vaccination

1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly

BIOLOGICAL

intra-lesional vaccine administration

1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally

PROCEDURE

therapeutic resection of the lesion

at week 15, all residual lesions will be resected

DRUG

imiquimod

imiquimod applied to the cervix by the physician

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Cornelia L Trimble, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00988559 on ClinicalTrials.gov