A Phase I Clinical Trial of an HPV Therapeutic Vaccine

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Arkansas
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01653249
First received: July 26, 2012
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Human Papillomavirus
Biological: Vaccine consisting of four HPV-16 E6 peptides in combination with Candin®
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase I Clinical Trial of an HPV Therapeutic Vaccine

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • safety [ Time Frame: immediately then up to 7 days post vaccinations ] [ Designated as safety issue: Yes ]
    real-time safety measurement of the combined administration of HPV vaccine and Candin® as measured by dose limiting toxicity as defined by adverse events; safety will be assessed at time of vaccination, 30 minutes post-injection, and daily for 7 days post injections.


Secondary Outcome Measures:
  • clinical and virological/immunological response to the HPV vaccine [ Time Frame: within weeks of vaccinations or procedures ] [ Designated as safety issue: No ]
    Clinical response as defined by loop electrical excision procedure (LEEP); virological assessment to assess the clearance of HPV infection after vaccination; immunological assessments of T-Cells and circulating immune cells (regulated T-Cells and myeloid derived suppressor cells); and assessment of cervical immune cells.


Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vaccination
an escalating dose study of a vaccine consisting of four HPV-16 E6 peptides in combination with Candin® to determine the clinically optimum dose (COD), immunologically optimal dose (IOD), and maximum tolerated dose (MTD). An additional 30 subjects will be vaccinated at the final dose (apparent COD) for further assessment of clinical response.
Biological: Vaccine consisting of four HPV-16 E6 peptides in combination with Candin®

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653249

Contacts
Contact: Shawna S Owens, BSB, CCRP 501-526-7657 owensshawnas@uams.edu

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Shawna S Owens, BSB, CCRP    501-526-7657    owensshawnas@uams.edu   
Principal Investigator: Mayumi Nakagawa, MD, PhD         
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Mayumi Nakagawa, MD, PhD University of Arkansas
Principal Investigator: William W Greenfield, MD University of Arkansas
  More Information

Additional Information:
No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01653249     History of Changes
Other Study ID Numbers: 130662, R01CA143130
Study First Received: July 26, 2012
Last Updated: September 16, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Arkansas:
human papillomavirus (HPV)
vaccine
treatment

ClinicalTrials.gov processed this record on September 30, 2014