A Phase I Open Label, Dose Escalation Clinical Trial Assessing the Safety, Tolerability, and Feasibility of pNGVL4aCRTE6E7L2 HPV DNA Vaccine Administration Via Intramuscular TriGridTM Electroporation Delivery System to Patients With HPV16-Positive High-Grade Cervical Intraepithelial Neoplasia

Who is this study for? Adult female patients with HPV16-positive cervical neoplasia
What treatments are being studied? pNGVL4aCRTE6E7L2
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 19
Healthy Volunteers: t
View:

• 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.

⁃ 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) \<1.5 X the upper institutional limit of normal Alanine transaminase (ALT) \<1.5 X the upper institutional limit of normal Creatinine ≤1.5 x upper institutional limit normal

• The effects of pNGVL4aCRTE6E7L2 DNA vaccine on the developing human fetus is unknown. For this reason, women of child-bearing potential must agree to use two forms of acceptable contraception, including one barrier method, prior to study entry and for 3 months after study completion. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.

‣ 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:

• i. Women who are permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) ii. Women who have experienced total cessation of menses for at least 1 year OR who have a previous clinical follicle stimulating hormone (FSH) value \> 40 mIU/mL c. The following are acceptable forms of barrier contraception: i. Male or female condom, ii. Diaphragm, cervical/vault cap, or contraceptive sponge when used with spermicidal foam/gel/cream/suppository.

• d. The following are acceptable forms of secondary contraception, when used with a barrier method and spermicide: i. Placement of an intrauterine device (IUD) ii. Established use of oral, injected, or implanted hormonal methods of contraception

• Ability to understand and the willingness to sign a written informed consent document.

• Participant is able to adhere to the study visit schedule and other protocol requirements.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Contact Information
Primary
Kimberly Levinson, MD
klevins1@jhmi.edu
4109558240
Backup
Ashish Solanki, RN
asolank2@jhmi.edu
410-614-6702
Time Frame
Start Date: 2020-09-14
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 48
Treatments
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
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov