Protein is >80% pure as determined by 10% PAGE (coomassie staining).
Human Papillomavirus (HPV) is a small, non-enveloped DNA virus that infects epithelial cells, particularly those of the skin and mucous membranes . The virus has a circular, double-stranded genome approximately 8 kilobases in length, encoding six early proteins responsible for viral replication and two late structural proteins, L1 and L2 . There are over 100 known genotypes of HPV, with at least 13 classified as high-risk due to their association with various cancers, including cervical, anogenital, and oropharyngeal cancers .
HPV types are categorized based on their oncogenic potential. High-risk types, such as HPV 16 and 18, are responsible for approximately 70% of cervical cancers worldwide . Low-risk types, including HPV 6 and 11, are primarily associated with benign conditions like genital warts and recurrent respiratory papillomatosis (RRP) . HPV 11, in particular, is known to cause around 90% of genital warts and a significant proportion of RRP cases .
Recombinant technology has been pivotal in developing prophylactic HPV vaccines. These vaccines are composed of virus-like particles (VLPs) formed by the self-assembly of the recombinant L1 capsid protein from various HPV types . The VLPs mimic the structure of the native virus but lack viral genetic material, rendering them non-infectious .
The recombinant L1 protein of HPV 11 is produced using yeast cells or insect cells infected with recombinant baculoviruses . This protein self-assembles into VLPs that resemble the native virions of HPV 11 . These VLPs are then purified and used as the active ingredient in vaccines like Gardasil, which targets HPV types 6, 11, 16, and 18 .
The primary mechanism of action for HPV vaccines involves the induction of a robust immune response against the L1 protein, leading to the production of neutralizing antibodies . These antibodies prevent the virus from infecting epithelial cells, thereby reducing the incidence of HPV-related diseases . Clinical trials have demonstrated that these vaccines are highly effective in preventing infections with the targeted HPV types and the associated diseases .