Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)
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.
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
Study Design
Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
HPV16+
Intervention
DNA vaccination, Gene gun vaccine, intramuscular vaccination, intra-lesional vaccine administration, therapeutic resection of the lesion
Location
University of Alabama at Birmingham
Birmingham
Alabama
United States
35294
Status
Recruiting
Source
Sidney Kimmel Comprehensive Cancer Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00988559
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:18:53-0400
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Medical and Biotech [MESH] Definitions
Mass Vaccination
Administration of a vaccine to large populations in order to elicit IMMUNITY.
Vaccinia
The cutaneous and occasional systemic reactions associated with vaccination using smallpox (variola) vaccine.
Smallpox Vaccine
A live VACCINIA VIRUS vaccine of calf lymph or chick embryo origin, used for immunization against smallpox. It is now recommended only for laboratory workers exposed to smallpox virus. Certain countries continue to vaccinate those in the military service. Complications that result from smallpox vaccination include vaccinia, secondary bacterial infections, and encephalomyelitis. (Dorland, 28th ed)
Anti-vaccination Movement
Group activities directed against VACCINATION.
Diphtheria-tetanus Vaccine
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
