A Phase I Clinical Trial of an HPV Therapeutic Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01653249
Recruitment Status : Completed
First Posted : July 30, 2012
Last Update Posted : October 12, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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 or disease Intervention/treatment Phase
Human Papillomavirus Biological: Vaccine consisting of four HPV-16 E6 peptides in combination with Candin® Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase I Clinical Trial of an HPV Therapeutic Vaccine
Study Start Date : August 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
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®

Primary Outcome Measures :
  1. safety [ Time Frame: immediately then up to 7 days post vaccinations ]
    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 :
  1. clinical and virological/immunological response to the HPV vaccine [ Time Frame: within weeks of vaccinations or procedures ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01653249

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
National Cancer Institute (NCI)
Principal Investigator: Mayumi Nakagawa, MD, PhD University of Arkansas
Principal Investigator: William W Greenfield, MD University of Arkansas

Additional Information:
Responsible Party: University of Arkansas Identifier: NCT01653249     History of Changes
Other Study ID Numbers: 130662
R01CA143130 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2012    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016

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

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs