HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia

ConditionsHuman Papillomavirus Type 16 Cervical Intraepithelial Neoplasia Grade II Cervical Intraepithelial Neoplasia, Grade III

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexFemale

Age19+

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

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.

Disqualifiers

Patients with high-grade cervical intraepithelial lesions (CIN2/3) that are HPV16 negative

For the HIV+ cohort only: patients with AIDS related symptoms comprising an active AIDS-associated infectious process that, in the view of the investigator, would limit the subject's ability to comply with study procedures.

For the HIV+ cohort only: patients with an HIV viral load >200 cp/mL.

Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within 6 months of study entry; For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day; inhaled and topical steroids are allowed.

Trial design

Design model

Sequential

Treatments tested in this trial

pNGVL4aCRTE6E7L2
Drug
The dose escalation will start from the lowest dose level of 0.3 mg. This dose cohort will consist of 3 participants and a monitoring period of one week after the final dose mandated. If there are 0 participants in the 0.3 dose level cohort that experience dose limiting toxicities (DLT), a new cohort of 3 participants will be vaccinated at the 1.0 mg dose level. If there are 0 participants in the 1.0 mg dose level that experience DLT, then a new cohort of 3 participants will be vaccinated at the 3.0 mg dose level. If there is 1 participant experiencing DLTs, an additional cohort of 3 subjects will be enrolled and treated at the current dose level. If there are 2 or more participants experiencing DLTs in the 3 or additional cohort of 3 vaccinated at the current dose level, then the next lower dose level will be determined as the Maximum Tolerated Dose (MTD).

Treatment groups

48 Participants

are divided into 3 treatment groups

Group A: Vaccination Arm Level 1Other 1 intervention

Group B: Vaccination Arm Level 2Other 1 intervention

Group C: Vaccination Arm Level 3Other 1 intervention

Trial outcomes

Primary outcomes

Number of participants experiencing dose limiting toxicities at each dosing level

The safety and tolerability of pNGVL4aCRTE6E7L2 DNA vaccine will be determined using the number of participants experiencing dose limiting toxicities at each dosing level.

Time frame

1 week

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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