University of Alabama Developing New HPV-Vaccine

Cervical cancer fight lands at UAB
Birmingham trials slated for more effective HPV vaccine

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.

If successful, the vaccine’s impact on cer­vical cancer could be enormous.

“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.

In development

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.


Aimee Holland, a nurse practitioner at UAB Student Health Services, prepares a syringe filled with Gardasil, a vaccine that protects women from HPV infections. It takes three shots of the vaccine to stimulate immunity against types of HPV that cause cervical cancer and genital warts.

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.”

Birmingham trials
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.


Young women coming into UAB Student Health Services are met with marketing materials for Gardasil, including this pamphlet with a built-in MP3 player.

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.

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.