HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia

Conditions

• Cervical Intraepithelial Neoplasia Grade II
• Cervical Intraepithelial Neoplasia, Grade III
• Human Papillomavirus Type 16

Eligibility Criteria

Sex

FEMALE

Age

19 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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).

Study Details

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+.

Key Dates

Start date

Sep 14, 2020

Status verified

Aug 2025

Primary completion

Dec 1, 2026

Completion

Jun 1, 2028

Study Design

Enrollment

48 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Other: Vaccination Arm Level 1
  The dose escalation of pNGVL4aCRTE6E7L2 will be conducted to evaluate the safety of three escalating doses; Level 1 dose of 0.3 mg
• Other: Vaccination Arm Level 2
  The dose escalation of pNGVL4aCRTE6E7L2 will be conducted to evaluate the safety of three escalating doses; level 2 at dose 1.0 mg
• Other: Vaccination Arm Level 3
  The dose escalation of pNGVL4aCRTE6E7L2 will be conducted to evaluate the safety of three escalating doses; level 3 dose of 3.0 mg

Primary Outcome Measure

Number of participants experiencing dose limiting toxicities at each dosing level [ Time Frame: 1 week ]

Central Contacts

• Kimberly Levinson, MD
  4109558240
  [email protected]
• Ashish Solanki, RN
  410-614-6702
  [email protected]

Locations (2)

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