RecruitingPhase 1

HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia

United States48 participantsStarted 2020-09-14

Plain-language 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+.

Who can participate

Age range19 Years

SexFEMALE

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Inclusion criteria

✓. 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.
✓. 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.
✓. Patients must be willing to comply with effective Antiretroviral Therapy.
✓. Women of childbearing potential are defined as any female who has experienced menarche and does not meet the criteria for "women not of childbearing potential" defined below.
✓. Women not of childbearing potential are defined as follows:

What they're measuring

Number of participants experiencing dose limiting toxicities at each dosing level

Timeframe: 1 week

Trial details

NCT IDNCT04131413

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Kimberly Levinson, MD

4109558240 klevins1@jhmi.edu

View on ClinicalTrials.gov More Human Papillomavirus Type 16 trials