Human papillomaviruses (HPVs) are one of the most common
sexually transmitted infections and remains a public health problem worldwide. There is strong evidence that HPV causes cervical, vulva and
vaginal cancers,
genital warts and
recurrent respiratory papillomatosis. The current treatments for HPV-induced
infections are ineffective and recurrence is common-place. Therefore, to reduce the burden of HPV-induced
infections, several studies have investigated the effi cacy of different prophylactic
vaccines in clinical human trials directed against HPV types 6, 11, 16, or 18. Notably, these HPV types contribute to a signifi cant proportion of disease worldwide. This review will focus on the published results of Merck & Co's prophylactic quadrivalent
recombinant vaccine targeting HPV types 6, 11, 16, and 18 (referred to as
Gardasil((R))). Data from the Phase III trial demonstrated that
Gardasil was 100% effi cacious in preventing precancerous lesions of the cervix, vulva, and vagina and effective against
genital warts. Due to the success of these human clinical trials, the FDA approved the registration of
Gardasil on the 8 June 2006. In addition, since
Gardasil has been effi cacious for 5 years post vaccination, the longest evaluation of an
HPV vaccine, it is expected to reduce the incidence of these type specifi c HPV-induced diseases in the future.