Spots Global Cancer Trial Database for HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
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Trial Identification
Brief Title: HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
Official Title: A Phase I Open Label, Dose Escalation Clinical Trial Assessing the Safety, Tolerability, and Feasibility of pNGVL4aCRTE6E7L2 HPV DNA Vaccine Administration Via Intramuscular TriGridTM Electroporation Delivery System to Patients With HPV16-Positive High-Grade Cervical Intraepithelial Neoplasia
Study ID: NCT04131413
Interventions
Study Description
Brief Summary: The primary goal of this phase I open label study is to determine the safety and tolerability of pNGVL4aCRTE6E7L2 DNA vaccine, as administered by intramuscular (IM) injection with TriGrid™ electroporation to both HIV- or HIV+ adult female subjects (≥ 19 years), with biopsy confirmed cervical intraepithelial (CIN) II or III that is human papillomavirus (HPV) 16+.
Detailed Description:
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Johns Hopkins University, Baltimore, Maryland, United States
Contact Details
Name: Kimberly Levinson, MD
Affiliation: Johns Hopkins University
Role: PRINCIPAL_INVESTIGATOR
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