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| |  Each year, about a half-million women, 80 percent of them living in low-income countries, develop cancer of the cervix. The disease kills 250,000 women annually, and is the second leading cause of cancer deaths among women living in less developed countries. Nearly all cases of cervical cancer are caused by infection with human papillomavirus (HPV), the most common viral infection of the reproductive tract. Dr. Garcea's team is working to develop an inexpensive therapeutic vaccine against HPV that will not only protect people from developing new infections, but could potentially trigger an immune system response to cure those who are already infected.
Building on the research that led to the current prophylactic vaccines for HPV infection, the project team is working to develop the next generation of vaccines to both prevent and treat HPV infection. The team proposes to use a novel protein composed of a protein that contributes to coating the virus fused to a protein produced after HPV infection to elicit the development of antibodies that protect against the new infections and to trigger an immune response that would destroy cells already infected with the virus.
The project includes plans to identify and develop the optimal vaccine candidate, produce the vaccine for use in humans, and conduct the first trial of the vaccine to evaluate its safety in young women.
Dr. Garcea's team has been working to identify the best protein candidate for a therapeutic vaccine while simultaneously planning for eventual vaccine production and testing.
The project team expects to begin adapting its work in the laboratory to manufacturing after which toxicology testing and clinical trials will follow
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| | | The pre-clinical phase of this project (the selection of the optimal chimeric capsomere candidate for GMP production and clinical trials) is near completion. We have expressed, purified, and tested greater than 20 “chimeric capsomere” constructs. We have narrowed our candidate vaccines based upon multiple factors: a) performance in several immunologic model systems, b) efficiency of expression, purification, and resistance to proteolysis, and c) stability upon precipitation and storage. At present, the candidates best fitting these criteria are undergoing final evaluation. We will initiate the upstream manufacturing development phase with BioSidus within the next few months. The preferred vaccine candidate then will be optimized for biomanufacture. | | | | | Selected BioSidus, a company in Buenos Aires, for production of vaccine. | | | | | Planning for clinical trial at the Ludwig Cancer Institute in Sao Paulo, Brazil. | | |
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| | | Dr. Richard Schlegel, Georgetown University School of Medicine, Washington DC, United States - US | | | | | Dr. Lutz Gissmann, Deutsches Krebsforschungszentrum, Heidelberg, Germany - DE | | | | | Dr. Andres Bercovich, BioSidus, Brazil - BR | | | | | Dr. Luisa Villa, Ludwig Cancer Institute, Brazil - BR | | |
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