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.
INVESTIGATORS
PRINCIPAL INVESTIGATOR
Mayumi Nakagawa, MD, PhD
Department of Pathology
CO-INVESTIGATOR
William Greenfield, MD
Department of Obstetrics
and Gynecology
FUNDING
National Cancer Institute
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.
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
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
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.
COMPENSATION
Up to $250 if you qualify
Validated parking
CONTACT
Shawna Owens
(501) 526-7657
[email protected]
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 West Markham St., Little Rock, AR
(501) 526-7657