In the early 1980s, Richard Schlegel, a cell biologist, was researching a little-known virus in cows when he heard that a scientist in Germany had found a link between the same virus in humans and cervical cancer.

Inspired, Schlegel turned his research to the human papillomavirus, which led him to join Bennett Jenson and Shin-je Ghim at Georgetown University Hospital. Twenty-five years later, their work has provided the cure that the medical world has been searching for.

“You think, you know, `Why do you want to study that? It’s a cow virus,'” Schlegel said. “I mean, I didn’t start out thinking that our research would have that impact, because we were just studying a little virus, a cow virus.”

The vaccine that Schlegel and his colleagues created, called Gardasil, is the first that can prevent the development of cancer. It targets specific strains of HPV that have been proven to cause nearly every case of cervical cancer.

In the United States, more than 9,700 women contract cervical cancer per year, and 3,700 die from it. Minorities and women in rural areas are much more susceptible to developing cervical cancer because they generally do not have the same access to preventative care measures like the Pap smear.

“Because certain racial and ethnic groups bear a disproportionate burden of cervical cancer, the vaccine has the potential to reduce certain health disparities,” said Georgetown Professor Shelly Nelson, who teaches a class on women’s health issues. “Clearly, this has the potential to save women’s lives.”

Finding the Cure

As in all scientific research, the Georgetown team encountered glimmers of hope and disappointing setbacks as its investigation moved forward.

When the researchers started their work in the late 1980s, they first tried to make antibodies that would react with the structure of the main protein in HPV, but it failed. For their next hypothesis, they looked to see if the shape of the protein affected the reaction of the antibodies. This time, the theory paid off.

“That sort of changed the whole field for us and for everyone else,” Schlegel said.

During the next phase, the researchers tested the antibodies on animals and found that dogs that got injections of the correctly shaped protein were completely protected from the virus. They published their results in 1995 in the Proceedings of the National Academy of Sciences, a top medical journal, to announce their discovery to the world.

Three other research groups had been working on HPV vaccines, however, and they all submitted patent applications around the same time as the Georgetown team. To determine who deserved the U.S. patent, the court called an interference period of 10 years while it investigated each group’s work.

A decade later, the U.S. patent court ruled in Georgetown’s favor, saying that the team’s findings on the importance of the protein’s shape made its research more significant.

The FDA approved Gardasil last June after trials demonstrated that the vaccine was 100 percent effective against the strains of HPV that cause most cervical cancer.

“It really is unique and rare when you can actually make the steps to animal studies and then the steps to human studies and it works all the way,” Schlegel said. “If you look at drug development, the vast majorities of drugs you develop that looked good in animals just fizzle when they go into human trials.”

For now, Gardasil is approved only for women, but it is currently being tested on men. Gardasil proved to be highly effective at preventing genital warts during testing in women, and Schlegel said it could potentially protect men from them as well.

The Student Health Center has already ordered Gardasil, and it should be available to students by early November at a discounted price, depending on health insurance. The FDA recommends that all girls and women ages nine to 26 receive the vaccine.

The Future

Although Jenson and Ghim have since left for the University of Louisville, Schlegel continues to tinker with the vaccine in his lab here.

“I’m hoping that we can integrate with a lot of the international programs and Georgetown’s interest in global health to actually make this work a lot better,” Schlegel said.

Because Gardasil is the most expensive vaccine ever, at a price of $360 for a three-shot course, journalists and scholars have voiced concerns that the vaccine will not get where it is needed most: the developing world.

Worldwide, cervical cancer is a major killer of women because developing countries’ access to treatment is rare, much less to preventative care measures. The most recent statistics from the World Health Organization show that 239,000 women died of cervical cancer in 2002.

To address this problem, Schlegel and fellow researcher Bob Garcia of the University of Colorado received a prestigious $3.5 million grant from the Bill and Melinda Gates Foundation.

The researchers have fine-tuned the process of making the vaccine to cut costs, and they have found a way to make it into a white powder that doctors can mix into liquid onsite, whether they are in dense urban areas of the Indian subcontinent or remote villages in Africa.

Schlegel and Garcia are also working on a therapeutic vaccine with other researchers. This version would be used to treat women who have been diagnosed with cancer so that they would not have to undergo a full hysterectomy, as patients usually do now.

“[For] people who already have infections,” Schlegel said, “we’re hoping we can cure them.”