A Phase I Clinical Trial of an HPV Therapeutic Vaccine



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 50
Updated:7/29/2016
Start Date:August 2012
End Date:July 2015

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This study will consist of 300 women aged 18-50 years. The study will show that a new
therapeutic human papillomavirus (HPV) vaccine designed to regress a precancerous condition
called high-grade squamous intraepithelial neoplasia (HSIL)is safe. HPV is known to cause
cervical, vaginal, oral, and anal cancers. This novel vaccine will consist of a
synthetically made fragment of HPV protein called E6 and yeast extract called Candin®.
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. Volunteers would be eligible to enroll
in the study if they have had a recent Papanicolaou (Pap) smear result indicating HSIL or
"Cannot rule out HSIL", and if they meet the inclusion/exclusion criteria. Subjects will be
eligible to receive vaccinations if biopsy confirms HSIL. A series of four vaccinations will
be given roughly 3 weeks apart, and LEEP will be performed at the end of the study
approximately 12 weeks after the last vaccination.


Inclusion Criteria:

- Aged 18-50 years

- Had recent Pap smear result consistent with HSIL or "cannot rule out HSIL" or HSIL on
biopsy

- Untreated for HSIL or "Cannot rule out HSIL"

- Able to provide informed consent

- Certain physical exam and blood component parameters within acceptable ranges

- Willingness and able to comply with the requirements of the protocol with a good
command of the English language

Exclusion Criteria:

- History of disease or treatment causing immunosuppression (e.g., cancer, HIV, organ
transplant, autoimmune disease)

- Being pregnant or attempting to be pregnant within the period of enrollment

- Breast feeding or planning to breast feed within the period of enrollment

- Allergy to Candida antigen

- History of severe asthma requiring emergency room visit or hospitalization

- Current use of beta-blocker medication (may not respond to epinephrine in case of
anaphylaxis)

- If in the opinion of the Principal Investigator or other Investigators, it is not in
the best interest of the patient to enter this study
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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mi
from
Little Rock, AR
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