This article was originally Posted by Dave Parks in the Birmingham News on March 30, 2009. Knowing that I follow the HPV-vaccine issue, a friend forwarded the article to me. I usually follow the economic issues around Merck’s HPV vaccine, Gardasil, so I was fascinated by what a low cost entry into the HPV-Vaccine market might mean to both the fight against cervical cancer in low-resourse countries and to Merck’s bottom line. Stay tuned…
UAB will conduct clinical trials for a new, less expensive and more effective HPV vaccine that could revolutionize the worldwide fight against cervical cancer, researchers say.
The University of Alabama at Birmingham is expected to start trials late this year or early next year for the vaccine, which was developed at Johns Hopkins University and is being produced in India.
“You’d wipe it off the face of the Earth, like smallpox,” said Dr. Edward E. Partridge, director of the UAB Comprehensive Cancer Center.
The World Health Organization estimates that cervical cancer kills 286,000 women a year, primarily in undeveloped nations where medical screening and treatment are unavailable.
“Cervical cancer worldwide is the second leading cancer killer of women,” said Partridge, who has spent decades building cervical cancer prevention programs in impoverished areas of Alabama and Mississippi.
In addition to addressing a huge health problem in the developing world, this vaccine could save billions of dollars a year in medical expenses for the U.S. by eliminating the enormous cost of screening for cervical cancer and treating early stages of the disease.
The only existing vaccine for human papillomavirus, Gardasil, is effective against two HPV types, which cause about 70 percent of all cervical cancer. There are 13 additional HPV types that cause the other 30 percent of cervical cancer. Thus, women getting Gardasil must continue with screening through Pap tests.
Moreover, Gardasil is expensive, costing about $120 a shot, with three required for full vaccination.
Richard B.S. Roden, a researcher at Johns Hopkins who was trained at the National Cancer Institute, has spent a decade developing the new vaccine. He said it will protect against a wider range of HPV types than Gardasil and can be produced for perhaps less than $1 a dose.
The difference is in the design, Roden said.
Gardasil contains what are essentially empty HPV viruses, or capsids. These capsids trick the immune system into thinking the body has been invaded by HPV. The result is at least seven years of immunity from the HPV types included in the vaccine, Roden said.
The new vaccine is based on a common protein found in many HPV types. Animal studies have shown that this protein also triggers an immune response, but against all 15 HPV types known to cause cervical cancer, Roden said.
And it would be inexpensive to make, given a much simpler manufacturing process. Roden has already contracted with Shantha Biotechnics Ltd. of India, a company known for making inexpensive vaccines distributed by the World Health Organization. Shantha is now producing the initial batches of vaccine for clinical trials in Birmingham.
“The animal data is very supportive that it will work,” Roden said. “My biggest concern is how long the protection will last.”
The clinical trials should provide that information, he said. “We’ll just have to wait and see.”
Dr. Warner K. Huh, a gynecologic oncologist at UAB who worked on the Gardasil vaccine trials, will lead the new clinical trials.
Huh said the new vaccine will go through toxicology trials before being tested on people in Alabama.
The Gardasil trials have provided a kind of road map for these new trials, he said. As with Gardasil, researchers will be able to quickly gauge the new vaccine’s effectiveness by measuring antibodies in blood.
At best, a new vaccine could be available in five years; at worst, it could take 15, Huh said.
Huh said UAB will be the only testing site anywhere for the vaccine. The medical center is one of the busiest in the nation when it comes to providing care to patients with cervical cancers and pre-cancerous conditions, he said.
UAB serves rural, poverty-stricken areas with many minorities. People living in these areas are at higher risk for cervical cancer than most Americans, Huh said.
People living in poverty seldom get Pap smears. Thus, they don’t get medical procedures to halt the progression of abnormal conditions toward cancer.
And, the region has high rates of smoking, something that contributes greatly to cervical cancer when combined with HPV infection.
“There’s a third factor,” Huh said. “African-American women have a higher proclivity for developing these lesions … We’re not sure why.”
As a result, UAB has contact with large numbers of patients who need cervical cancer prevention services, screening and care, and are willing to participate in clinical trials.
“All these patients get referred to us, and we’ve almost become a clinical and research clearing house,” Huh said. “There was one point in our clinic here that 75 percent of our patients were enrolled in a clinical trial. We’re talking about 1,500 patients. It’s one of the top three largest trials ever at UAB in terms of enrollment.”
About 50 patients will be involved in the first trial, designed to test the vaccine’s safety. The second trial will concentrate on dosing, and if a third trial is warranted, it will likely involve many medical centers.
“If we can prove that the vaccine is effective in Phase 1 and Phase 2 trials, where it goes after that is actually going to be amazing,” Huh said.