Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3) (NCT00988559) | Clinical Trial Compass
CompletedPhase 1
Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)
United States132 participantsStarted 2009-09
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* patients with high grade cervical intraepithelial lesions (CIN2/3)
* patients whose lesions are HPV16+
* patients who are age 18 or older
* patients who are able to give informed consent
* patients who are immunocompetent
* patients who are not pregnant, committed to using adequate contraception if of childbearing age
* patients who have a minimum hemoglobin level of 9
Exclusion Criteria:
* Patients with cytologic evidence of glandular dysplasia
* Patients with cytologic evidence of adenocarcinoma in situ
* Patients who are pregnant
* Patients with an active autoimmune disease
* Patients who are taking immunosuppressive medication
* Patients with concurrent malignancy except for nonmelanoma skin lesions
* Patients who have an allergy to gold.
* Patients with any evidence of damaged skin, or moles, scars, tattoos or marks at the proposed site(s) of administration that might interfere with the interpretation of local skin reactions.
* History or evidence of a physician-diagnosed chronic or recurrent inflammatory skin disease (e.g. psoriasis, eczema, atopic dermatitis, hypersensitivity) at the proposed site of administration in the past 5 years.
* Patients who have an active autoimmune disease or history of autoimmune disease requiring medical treatment with systemic immunosuppressants, including: inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemic, or immune thrombocytopenia, rheumatoid arthritis…
What they're measuring
1
Number of Participants With Related Serious Adverse Events
Timeframe: 9 months
Trial details
NCT IDNCT00988559
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins