The vaccine's technology was generated by a team of Georgetown University researchers in the early 1990s and licensed for commercial development. On June 8, the Food and Drug Administration approved the vaccine, which scientists say could eliminate most new cases of cervical cancer worldwide. Called Gardasil, the vaccine blocks four strains of HPV, including two that give rise to nearly 75 percent of cervical cancer cases and two other strains that cause about 50 percent of genital warts.
"It's a researcher's dream … to see something that started as a very cerebral idea in the laboratory to advance through animal and clinical trials, gain FDA approval and ultimately have a major global impact," Schlegel said. "It's highly unlikely but extremely gratifying to see it through so far."
Schlegel, professor and chair of Georgetown's Department of Pathology, in the Lombardi Comprehensive Cancer Center, began a research project in the late 1980s studying the molecular biology of the human papillomavirus (HPV), the precursor to most cervical cancers. Looking at the biological makeup of the virus through an advanced microscope, Schlegel said he never imagined he was laying the groundwork for something that could change the face of global medicine.
Instead, he focused on the millions of people worldwide infected with the sexually transmitted disease, particularly those in developing countries where HPV strikes 400,000 women annually. Without access to routine preventative care and annual Pap screening, HPV can develop into cervical cancer, the most common form of cancer and the leading cause of cancer deaths among women in developing nations.
"We realized these deaths were largely preventable … that's really all the motivation we needed," he said.
"For the past two decades, Dr. Schlegel has been a leader in improving public health for men, women and children around the world," said Stuart Bondurant, MD, interim executive vice-president for health sciences at Georgetown University Medical Center. "His important work to develop a preventative cervical cancer vaccine will save millions of lives and is rooted in Georgetown's mission of service to others."
A cell biologist by training, Schlegel came to Georgetown from the National Institutes of Health in 1990 to join forces with immunology and pathology experts A. Bennett Jenson, PhD, and Shin-je Ghim, PhD, who were studying how cervical cancer originates after HPV infection. Together, the researchers based the vaccine on the protein that comprises the virus's outer shell. This protein stimulates an immune response in the body that attacks the virus, disabling it before reproduction and infection can occur.
"At the time, Georgetown had one of the strongest HPV research programs of any institution in the country ... you couldn't have asked for a more capable team of people," Jenson said. "We were the right group of people, at the right time, with the right stars shining in our direction."
Ghim remembers that once the three researchers began working together, they knew they were on to something. "Progress was slow at first, but we sensed it was coming. No one really believed in a vaccine's ability to prevent cancer," she said.
They first tested the vaccine in dogs and found it was 100 percent effective in preventing HPV infection. From there, they licensed the technology to an external company to begin clinical trials, which showed that the vaccine also protected women from contracting the virus.
"Once we were able to grow the virus [in cell cultures], things started happening quickly," he said. "It didn't take long at all for the vaccine to move through trials and into the hands of the pharmaceutical companies."
"The development and approval of this cervical cancer vaccine is a watershed moment in cancer research," said Anatoly Dritschilo, MD, interim director of Georgetown's Lombardi Comprehensive Cancer Center. "This promising work will have a major impact on the incidence of cervical cancer here in the United States and around the world."
Schlegel and another team of colleagues have also been awarded a $3.5 million grant from the Bill and Melinda Gates Foundation and the National Institutes of Health to work on a second-generation vaccine that is protective and may be therapeutic to treat women infected by HPV. For more information on this award: http://explore.georgetown.edu/news/?ID=3013
For more information on Dr. Schlegel: http://gumc.georgetown.edu/lead_story.cfm?ObjectID=883
About Georgetown University Medical Center
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through our partnership with MedStar Health). Our mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis--or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, and the world renowned Lombardi Comprehensive Cancer Center. For more information, go to http://gumc.georgetown.edu.