NCT00988559

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

A Pilot Study of pnGVL4a-CRT/E7 (Detox) for the Treatment of Patients With HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives * To evaluate the feasibility and toxicity of vaccination in women with CIN2/3 caused by HPV16 * To evaluate the effect of vaccination on histology * To compare immunogenicity of three different routes of administration: intradermal (ID), intramuscular (IM), intralesional (IL). Secondary Objectives: * To evaluate changes in HPV viral load * To evaluate the cellular immune response to vaccination * To evaluate the humoral immune response to vaccination * To evaluate local tissue immune response * To correlate measures of immune response with clinical response * To correlate measures of immune response with those observed in the preclinical model

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-09-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2009-10-02
• Last updated: 2018-07-09
• Results posted: 2018-07-09

Locations

3 sites across 1 country: United States