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Cervical high-grade squamous intraepithelial lesion (HSIL) - Healing Genes
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Cervical high-grade squamous intraepithelial lesion (HSIL)

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REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

Reveal 2: A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™-5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix


Phase 2

DESCRIPTION:

Doctors at several research centers seek patients with cervical high-grade squamous intraepithelial lesion (HSIL) to trial a therapeutic DNA vaccine. This vaccine is a loop of selected DNA from the human papilloma virus which is known to cause cervical cancers. The body’s cells uses the genes to produce proteins that prompt the body to attack cervical cancer cells, killing the cancer.

Study participants will receive intramuscular injections 3 times over 12 weeks, along with a therapy that causes the muscle cells to better absorb the vaccine. Half the participants receive a placebo injection, and all will be followed for a total of 36 weeks.


PATIENT MUST:

  • Be female, age 18 or older
  • Not be pregnant or breastfeeding
  • Have confirmed cervical infection with HPV types 16 and/or 18 at screening

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. Intramuscular injection of the therapy or placebo, with CELLECTRA™-5PSP electric muscle stimulation to enhance absorption of the vaccine
  3. Repeat of step (2) at 4 weeks and 12 weeks
  4. Follow up with lab and physical assessments for up to 36 weeks.

LOCATIONS & CONTACTS:

 

Contact: Inovio Call Center  |  267-440-4237  |  [email protected]

 

The following study locations are participating:

Mesa Obstetricians and Gynecologist in  Phoenix, AZ.

Visions Clinical Research- Tucson in  Tucson, AZ

Women’s Medical Research Group in Clearwater, FL

Praetorian Pharmaceutical Research, LLC in Marrero, LA

Saginaw Valley Medical Research Group LLC in Saginaw, MI

Meridian Clinical Research Norfolk in Norfolk, NE

New Jersey Medical School in Newark, NJ

Suffolk Obstetrics and Gynecology in Port Jefferson, NY

Lyndhurst Clinical Research in Winston-Salem, NC

Magnolia Ob/Gyn Research Center, LLC   Recruiting in Myrtle Beach, SC

Group For Women – Tidewater Clinical Research Inc in Norfolk, VA

Puerto Rico Translational Research Center (PRTRC) in San Juan, PR

SPONSORS

Inovio Pharmaceuticals

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03721978

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