AUGUSTA, Ga. – A new vaccine against nine of the most harmful strains of human papillomavirus is under study at the Medical College of Georgia.
The vaccine, a nine-valent called V503, is being compared with Gardasil, a quadrivalent vaccine already on the market that works against the two most deadly HPV types.
Gardasil, approved by the U.S. Food and Drug Administration in 2006, protects against HPV types 16 and 18, which cause about 70 percent of HPV-related cervical cancer cases, and types 6 and 11, which cause about 90 percent of genital wart cases.
The new drug could prevent infection from those four types and five other cancer-causing types, Dr. Ferris says.
“Women infected with those five types of HPV also have an increased risk of developing severe precancerous cervical disease and cervical cancer,” he says. “While genital warts go away on their own in most cases, cervical precancerous lesions are less likely to disappear without treatment.”
HPV is incurable and Gardasil is the only preventive treatment on the market, Dr. Ferris says. Treatments range from topical creams to surgical removal of precancerous lesions.
Like Gardasil, the new vaccine contains proteins that form virus-like particles that assemble into a hollow sphere resembling HPV’s protective coating.
“Since the sphere lacks the actual viral DNA on the inside, it cannot cause HPV,” Dr. Ferris says. “But the body is tricked into making antibodies to protect against the real thing.”
In the previous Gardasil studies, half of the subjects were given Gardasil while the other half got a placebo (saline water). In this study, the placebo is Gardasil, so both groups get a vaccine.
“Either they’ll be vaccinated against four or nine types of HPV,” Dr. Ferris says. “It’s a win-win situation.”
The initial target group for the new vaccine will be females age 9-26 because most HPV infections occur among 15- to 25-year-olds. Risks associated with the study may include injection site pain and swelling; pelvic discomfort during the exam; and/or vaginal bleeding in cases where a biopsy is needed for further examination.
Study participants will have five to11 office visits over seven months to three-and-a-half years that will include physical and pelvic exams; Pap smears to detect cancerous or precancerous changes of the cervix; and HPV testing.
The study is open to healthy, non-pregnant women age 16 to 26 with no history of abnormal Pap tests.
Contact: For more information, call Dr. Ferris’ office at 706-721-2535.
Source: Medical College of Georgia