HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia

Recruiting Phase 1 Interventional Study
Human Papillomavirus Type 16 Cervical Intraepithelial Neoplasia Grade II Cervical Intraepithelial Neoplasia, Grade III
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
19 and older
Sex
Female
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Other
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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+.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 colp…
Contacts

Kimberly Levinson, MD

4109558240

klevins1@jhmi.edu

CONTACT

Ashish Solanki, RN

410-614-6702

asolank2@jhmi.edu

CONTACT