GlaxoSmithKline (GSK) has released Phase III trial results of its human papillomavirus (HPV) vaccine Cervarix for the prevention of cervical cancer in girls aged between nine and 14.
In the HPV-070 trial, 1,447 patients (aged nine to 25 years) across five countries were given Cervarix, which showed that two doses of the vaccine in girls aged nine to 14 years provide an immunogenicity matching to the currently licensed three-dose schedule in 15-25-year-olds.
Phase III trial data also confirms the results of an earlier proof of concept study, HPV-048, which also evaluated the immunogenicity of two doses of Cervarix compared with its three-dose schedule.
The HPV-048 study also showed that the immunogenicity of two doses of the vaccine in 9-14 year old girls is comparable to that seen with three doses in 15-25 year olds girls for both the vaccine HPV types 16 and 18 and for non-vaccine types 31 and 45, throughout the four-year study period.
The results suggest that the immune response of the two-dose schedule in girls aged nine to 14 years with Cervarix is in line with the three-dose schedule, as well as the safety profile is similar when compared with the three-dose group.
At present, Cervarix is only approved in the EU for use in females from the age of nine years, administered according to a three-dose schedule for the prevention of cervical, vulvar and vaginal lesions and cervical cancer causally related to certain oncogenic human papillomavirus (HPV) types.
In August, the company submitted a variation to the current marketing authorisation to the European Medicines Agency (EMA) to add administration of the vaccine according to a two-dose schedule in girls aged nine to 14-years-old.
Cervarix, as a two-dose schedule vaccination at months zero and six in girls aged between nine and 14 years old, is approved in nine countries including Guatemala, Honduras, El Salvador, Haiti, Suriname, Chile, Guyana, Nigeria and Ghana.
Image: High-grade dysplasia (carcinoma in situ) in the uterine cervix. Photo: courtesy of Haymanj.