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Recruiting NCT04131413

HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia

Conditions: Human Papillomavirus Type 16, Cervical Intraepithelial Neoplasia Grade II, Cervical Intraepithelial Neoplasia, Grade III

Sex: Female
Ages: 19 Years – N/A
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 48
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Location: University of Alabama at Birmingham Birmingham Alabama

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+.

Eligibility Criteria

Inclusion Criteria: * For the HIV- patient cohort only: patients with high-grade cervical intraepithelial lesions (CIN2/3) confirmed by colposcopy and biopsy who are HIV negative * For the HIV+ patient cohort only: patients with high-grade cervical intraepithelial lesions (CIN2/3) confirmed by colposcopy and biopsy that are HIV positive 1. HIV-1 infection, as documented by a rapid HIV-1 test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by western blot at any time prior to study entry. 2. Two HIV-1 RNA values ≤200 copies/mL at least 24 hours apart performed by any laboratory that has Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent may be used to document infection. 3. Patients must be willing to comply with effective Antiretroviral Therapy. * Patients whose cervical cytologic samples are HPV16+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test or other FDA-approved HPV genotyping test. Co-infections with HPV types other than HPV16 are permissible for study entry. * Age ≥19 years. Also due to Alabama law the age a person is no longer a minor needing parental consent is 19, so all participants need to be 19 or older. * Life expectancy of greater than 4 months. * Baseline Eastern Cooperative Oncology Group performance status of 0, 1 at the time of multi-modality treatment administration * Participants must have normal organ and marrow function within 45 days of enrollment as defined below: Absolute neutrophil count \> 1,500/mcL Cluster of differentiation (CD) 4 cell count \> 200/mcL Platelets \> 100,000/mcL Hemoglobin \> 10.0 g/dL Total bilirubin \< 1.5 X upper institutional limit of normal (patients with diagnosed Gilbert's Syndrome will not be excluded if direct bilirubin is within normal institutional limits) aspartate aminotransferase (AST) \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04131413). StuddyBuddy aggregates publicly available trial information.