HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia

PHASE1RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

September 14, 2020

Primary Completion Date

December 1, 2026

Study Completion Date

June 1, 2028

Conditions
Human Papillomavirus Type 16Cervical Intraepithelial Neoplasia Grade IICervical Intraepithelial Neoplasia, Grade III
Interventions
DRUG

pNGVL4aCRTE6E7L2

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).

Trial Locations (2)

21231

RECRUITING

Johns Hopkins University, Baltimore

35233

RECRUITING

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT04131413 - HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia | Biotech Hunter | Biotech Hunter