Washington, DC -- An award from the Bill and Melinda Gates Foundation and the National Institutes of Health is backing a Georgetown researcher who is working on an inexpensive, portable vaccine to treat women infected by human papillomavirus (HPV).
The vaccine also would protect others from becoming infected. HPV can cause cervical cancer, which is diagnosed in about 500,000 women each year and is the second leading cause of cancer death in women worldwide. Cervical cancer is especially problematic in developing countries, where 80 percent of the deaths from this malignancy occur.
The $3.5 million grant will be distributed among Dr. Richard Schlegel, professor and chair of pathology at the Lombardi Comprehensive Cancer Center, and researchers at the University of Colorado, the São Paulo Branch of the Ludwig Institute for Cancer Research, and the German Cancer Center in Heidelberg, Germany.
"We are thrilled that the collaborative work we are doing to develop a vaccine that can be easily used in women most at risk is being recognized and supported by this award," Schlegel said. "In many countries, detection and follow-up of HPV infection is nonexistent," he added. "Women around the world need a realistic answer."
The award is part of the Grand Challenges in Global Health initiative, launched by the Gates Foundation in partnership with the NIH. The initiative is designed to support research projects that discover and develop methods to prevent, treat and possibly cure diseases responsible for millions of deaths each year in developing countries. Fourteen Grand Challenges were identified for funding. The five-year grant to Schlegel and his colleagues falls under Grand Challenge #11: "Create immunological methods that can cure latent infection."
Schlegel's work centers on the biology of papillomaviruses and their role in the genesis of cervical cancer, and he has long worked on new
approaches to protecting women in developing countries against HPV. For example, his research into the protein shell that surrounds the HPV particle was developed into a technology that was first licensed to Medimmune and then sublicensed to GlaxoSmithKline (GSK). GSK is now in the final phase of testing a preventative HPV vaccine targeting cervical cancer, which has been shown in phase II clinical trials to provide complete protection against the two high-risk HPV types which are responsible for 70% of cervical cancers globally.
Schlegel and his colleagues are now working on a second-generation vaccine that is protective and therapeutic, which can be converted into powder. This vaccine will be able to be shipped dry, and then, when it reaches clinics, can be reconstituted with water and injected, Schlegel said. This proposed vaccine will be synthesized in bacteria as a fusion protein, making it inexpensive to produce and purify.
The majority of the grant funds will be spent on production of the vaccine, an effort led by the study's principal investigator, Colorado's Dr. Robert Garcea and on patient tests of its effectiveness, which will be conducted by Luisa Villa in Brazil. Schlegel and his group have been awarded $300,000 to verify the quality of the experimental vaccine once it is made, and they also will determine whether vaccinated patients have produced antibodies that indicate the vaccine is protective. Germany's Lutz Gissmann, Ph.D., will also screen cellular immune vaccine responses to determine the ability of the vaccine to treat existing HPV infections.
The first phase of clinical trial testing is expected to begin in two years, according to Schlegel, and will only enroll 25 to 50 women. Eventually thousands of women will be tested, he said, adding that it would likely be at least 10 years before a commercially viable product is produced.
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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.
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