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Abnormal Pap Smear Results?

If you were diagnosed with high-grade squamous intraepithelial lesion (HSIL) or “cannot rule out HSIL,” you may be eligible to enroll in a clinical trial being conducted at UAMS for treating HSIL using an HPV therapeutic vaccine.

 

About This Study

You are invited to take part in a research study. This study will consist of 300 study subjects. The study will look at the safety of a new therapeutic human papillomavirus (HPV) vaccine designed to regress precancerous condition called HSIL. HPV is known to cause cervical, vaginal, oral, and anal cancers. This novel vaccine will consist of synthetically made fragments of HPV protein called E6 and yeast extract called Candin® as a novel vaccine adjuvant. Our previous studies have revealed that immune response to E6 is important in fighting HPV. We also know that injecting Candin has anti-HPV effect since it has been used to treat common warts which are caused by different types of HPV. The current standard treatment for HSIL is loop electrical excision procedure (LEEP). The immune system is the part of the body that fights infection and cancer. This research study will also examine the immune response to the vaccine and its effectiveness in regressing HSIL. You would be eligible to enroll in the study if you have had a recent Papanicolaou (Pap) smear results indicating that you have HSIL or “cannot rule out HSIL”, and if you meet all of the inclusion/exclusion criteria. The presence of HSIL will be confirmed by performing a biopsy, and you’ll be eligible to receive vaccination if the diagnosis of HSIL is confirmed. You’ll also be eligible to enroll if you already had a biopsy confirming HSIL but are still untreated.

UAMS HPV Vaccine Trial

Is This Study Right for You?

We are looking for women ages between 18 and 50 who were recently diagnosed with HSIL or “cannot rule out HSIL” on Pap smear. The 1st visit is to confirm the diagnosis of HSIL by biopsy. If HSIL is confirmed and you meet other specific criteria, you’ll be eligible to receive vaccinations which will be given 4 times 3 weeks apart. The last visit will take place 12 weeks later for treatment called LEEP. You may also be eligible for vaccination if you already had a biopsy showing HSIL as long as you have not been treated. Download the brochure on the trial.

Qualifying or Screening Visit

  • Three OB-GYN clinic locations
  • Expected to take 90 min
  • Questionnaire
  • Medical history
  • Physical examination
  • Biopsy to confirm HSIL
  • Blood test

Vaccination Visits 1-4

  • UAMS Clinical Research Services Core Facility
  • Expected to take 60 min
  • Urine pregnancy test
  • Vaccine injection
  • Observation for 30 min
  • Blood test at visits 1 and 3

Treatment or Exit Visit

  • Three OB-GYN clinic locations
  • Expected to take 90 min
  • LEEP for treatment (will also tell us whether the vaccine was effective)
  • Questionnaire
  • Blood test

Vaccine Dose

  • You will receive the same dose of the vaccine throughout the study
  • The first 6 subjects to enroll will receive the lowest dose (50 micrograms)
  • The dose will be increased sequentially as long as safe (100, 250, and 500 micrograms)
  • Thirty additional subjects will receive the dose shown to be most effective

Investigators

Principal Investigator
Mayumi Nakagawa, MD, PhD
Department of Pathology

Co-investigator
William Greenfield, MD
Department of Obstetrics and Gynecology

Compensation

  • Up to $250 if you qualify
  • Validated parking

Funding

National Cancer Institute

Contact

Shawna Owens
(501)526-7657
owensshawnas@uams.edu

Locations

- OB-GYN Clinics
UAMS Women’s Clinic
Pulaski County Health Unit 2nd Floor
3915 West 8th St., Little Rock, AR

University Women’s Health Center
Freeway Medical Tower, 7th Fl, St. 705
5800 West 10th St., Little Rock, AR

UAMS West Little Rock Clinic
Pyramid Place
11300 Financial Center Pkwy, Little Rock, AR
(501)526-7425
1-866-273-3835

- UAMS Clinical Research Services Core
Central Building, Unit 4C, Clinical Research Center
4301 W. Markham St., Little Rock, AR
(501) 526-7657

UAMS HPV Vaccine Trial Brochure