HPVs are the causative agents of genital warts and cervical cancer, the second most common cancer in women worldwide. Most of the work on HPV prophylactic vaccine development has focused on the major virus structural protein L1. This protein has two oligomeric conformations: capsomeres which are L1 pentamers and capsids, which are composed of 72 capsomeres. Recombinant L1 protein will self assemble in vivo into capsid like structures referred to as virus like particles (VLPs). VLPs have a number of production problems that raises concerns whether they will ever represent a good HPV vaccine candidate. One means to circumvent these problems is to use L1 capsomeres which may have many advantages over VLPs related to production and scale-up. L1 capsomeres of HPV type 11 are antigenically similar to VLP's and when immunized with Freund's complete adjuvant neutralizing antibodies were induced in experimental animals. The objectives of this phase I application are to more thoroughly investigate the immunogenicity of capsomeres and to utilize molecular methods to simplify capsomere preparation. Successful completion of this phase I study will allow us to evaluate whether capsomeres are viable and perhaps superior alternatives to VLPs as the basis for HPV vaccines.
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