Although the HPV-16/18 vaccine is licenced in accordance with a three-dose schedule (Months 0, 1 and 6), a two-dose schedule is under evaluation in clinical trials (Month 0 and 6 or 12). In one recent clinical trial, the feasibility of adopting a two-dose (Month 0 and 6) schedule for 9–14 year olds has been supported on the basis of vaccine-specific antibody selleck inhibitor responses, as assessed by ELISA and on the basis of safety during 24 months of follow-up . Furthermore, two doses of the vaccine appeared as protective as three doses over the four years of follow-up, in one clinical trial where some vaccine recipients did not complete the three-dose schedule . The aim of this study was to
compare the quality of antibody responses in clinical trial recipients of two-doses (Months 0 and 6 in 9–14 year olds) or three-doses (Months 0, 1 and 6 in 15–25 year olds) of the HPV-16/18 vaccine by measuring antigen-specific antibody avidities. An initial step in this study was to characterise a modified ELISA for measuring avidity using the chaotropic agent NaSCN together with samples taken from other clinical trials of the HPV-16/18 vaccine using a three-dose (Months 0, 1 and 6) schedule. In Studies 1 and 2, serum samples were collected at 1-month post-Dose 2 (Month 2) and post-Dose ERK inhibitor 3 (Month 7)
from healthy female human subjects who had received three intramuscular injections (Months 0, 1 and 6) of the HPV-16/18 vaccine from clinical trials NCT00196924 (N = 30, 10–14 years old) and NCT00196937 (N = 35, 15–28 years old; N = 21, 29–41 years old; and N = 34, 42–55 years old)  and . In Study 3, serum samples were collected at 1, 18, or 42-months post-last dose (Months 7, 24 and 48) from human why healthy female subjects from clinical trial NCT00541970 who either had received the HPV-16/18 vaccine as two intramuscular injections (Months 0 and 6, N = 30, 9–14 year olds), or three intramuscular injections (Months 0, 1 and 6, N = 30, 15–25 year olds) . The serum samples for the study were randomly selected
from what was available in the clinical trial archives and with respect to the trial participants’ identification numbers. All serum samples were stored at −20 °C. All trials were approved by research ethics committees of the respective participating countries and conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Written informed consent was obtained from each trial participant who was at least the age of consent. Written informed assent was obtained from each trial participant below the age of consent in addition to written informed consent from her parent/guardian. One Cervarix® dose contains 20 μg of HPV16 Ll VLP, 20 μg of HPV18 Ll VLP, 50 μg 3-O-desacyl-4′-monophosphoryl lipid A (MPL) and 500 μg aluminium hydroxide.