A Phase I Clinical Trial of an HPV Therapeutic Vaccine

Human Papillomavirus Clinical Trial

Official title:

A Phase I Clinical Trial of an HPV Therapeutic Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653249
• Other study ID #: 130662
• Secondary ID: R01CA143130
• Status: Completed
• Phase: Phase 1
• First received: July 26, 2012
• Last updated: October 11, 2016
• Start date: August 2012
• Est. completion date: July 2015

Study information

• Verified date: October 2016
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

Biological:
• Vaccine consisting of four HPV-16 E6 peptides in combination with Candin®

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	clinical and virological/immunological response to the HPV vaccine	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.	within weeks of vaccinations or procedures	No

External Links

•   Homepage- The University of Arkansas for Medical Sciences