New Cervarix two-dose data demonstrate potential for increased flexibility of vaccine administration schedule

The Phase III clinical trial data from the ongoing HPV 070 (NCT01381575) study show that immunogenicity of two doses of Cervarix given at months 0 and 12 is non-inferior to vaccination given at 0 and 6 months, the currently licensed schedule.

This research demonstrates the potential for increased flexibility in timing of the administration of the second dose between month five and month 13, and may offer healthcare providers a more convenient once yearly vaccination option to help protect more girls against cervical cancer.

GSK vaccines medical director Dr Michael England noted that along with ensuring early and regular screening, uptake of HPV vaccination is one of the biggest challenges in safeguarding future generations of women from the disease.

"These data point to the possibility of a second two-dose administration schedule that could offer healthcare providers greater flexibility with the option of vaccinating two age groups at the same time. This could make immunisation programmes even easier to implement and may help to increase vaccination coverage," Dr England added.

The findings presented at ESPID are month 13 results from the ongoing HPV 070 clinical study. Month seven results from HPV 070, as well as findings from the HPV 048 (NCT00541970) study at month 48, formed the basis of the submission on which the recent marketing authorisation of a two-dose schedule of Cervarix was made.

These studies demonstrated that the immunogenicity and safety of two doses (0, six months) of Cervarix in nine to 14 year old girls is comparable to three doses (0, one and six months) in 15 to 25 year old girls and women in Europe.

The HPV 070 month 13 data corroborate the findings and support the opportunity for this additional flexibility within the two-dose schedule in the future. GSK has submitted a proposal for the Cervarix label to be updated to reflect the flexibility in administration of the second dose between five and 13 months after the first.

Additional data presented at ESPID and taken from the HPV 048 study, show that a two-dose (0, six months) schedule of Cervarix elicits an immune response in nine to 14 year old girls for up to five years post-vaccination and mathematical models predict that this could persist for over 20 years.

Further data from the HPV 070 study demonstrated that the quality of the immune response elicited by Cervarix were similar between the individuals who receive two-doses (0, six months) and those who received three doses (0, one, six months).

The quality of immune response was demonstrated using avidity index which can be considered as a marker of long term protection and specificity of the immune response. In summary, the available data for Cervarix is consistent in demonstrating that both the quantity and the quality of the immune response demonstrated with its two-dose schedule is in line with what was observed with its three-dose schedule.