A Phase I Clinical Trial of an HPV Therapeutic Vaccine

NCT01653249 | Completed Phase 1 DMC

• 2 other identifiers: 130662R01CA143130
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus

Keywords

human papillomavirus (HPV); vaccine; treatment

Outcome Measures

Primary Outcomes (1)

• safety

  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.

  immediately then up to 7 days post vaccinations

Secondary Outcomes (1)

• clinical and virological/immunological response to the HPV vaccine

  within weeks of vaccinations or procedures

Study Arms (1)

vaccination

EXPERIMENTAL

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®

Interventions

Vaccine consisting of four HPV-16 E6 peptides in combination with Candin® BIOLOGICAL

vaccination

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Study Officials

• Mayumi Nakagawa, MD, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

• William W Greenfield, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: July 30, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 12, 2016

Record last verified: 2016-10

Locations

US (1)