UofL evaluates safety of new therapeutic vaccine in women with HPV 16, 18 infections

Cervical cancer is the fourth most frequently occurring cancer in women. Human papillomavirus (HPV) is present in 99 percent of cervical cancers and is considered to be their cause. While most HPV infections will clear naturally within a few years, there has been no treatment available to hasten or improve the chance of natural eradication.

A new therapeutic vaccine, GTL001, developed by Genticel to clear HPV strains 16 and 18 - the types most likely to cause cancer - is being evaluated for safety in a Phase I clinical trial at the University of Louisville. Unlike prophylactic vaccines, which prevent diseases, therapeutic vaccines fight diseases after an individual is infected in a process known as immunotherapy. Physicians at UofL are seeking women with these infections to participate.

Although HPV infections are detected in a Pap smear, there has been no standard treatment to eradicate an infection other than hoping it will clear naturally and monitoring for the development of precancerous lesions. Thus, finding a treatment for HPV will be an important step in preventing cancer. Prophylactic vaccines can prevent some HPV infections, but they are not effective against existing infections.

"While prophylactic vaccines such as Gardasil® are available for those who choose to use them, many women are not choosing to be vaccinated. In addition, most of the women in our population are older than the vaccine movement, so they may not have had the vaccine and may have acquired HPV infections," said Diane Harper, M.D., M.P.H., M.S., chair of the Department of Family and Geriatric Medicine at UofL and a professor of obstetrics and gynecology.

Women age 25-65 who have been diagnosed with HPV 16 or HPV 18 are needed to participate in a small Phase I tolerability clinical trial of GTL001 with only a three-month follow-up period. Participants must not have high-grade lesions (HSIL) as determined by Pap smear. In addition, participants must not have received an HPV vaccine and must not be pregnant or breastfeeding.

Participants in the study will receive two injections at six-week intervals, as well as various tests and assessments. All study-related visits, tests and medications will be provided at no cost. In addition, participants may be reimbursed for travel expenses.

Participants will be enrolled through early 2016. Current trial locations include Louisville, Philadelphia and Columbus, Ohio.