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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
vaccination with pNGVL4a-CRT/E7(detox)
8 micrograms (group 1) or 16 micrograms (group 2)
1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly
1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally
at week 15, all residual lesions will be resected
imiquimod applied to the cervix by the physician
University of Alabama at Birmingham
Birmingham, Alabama, United States
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Number of Participants With Related Serious Adverse Events
Presence of intervention-related serious adverse events as defined by CTCAE
Time frame: 9 months
Absence of CIN2/3 Lesion by Week 15
Number of participants with no CIN2/3 lesion at the week 15 visit
Time frame: 15 weeks
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