Evidence for immunogenicity and safety of a fourth dose of vaccine in young adult females
STUDY DETAILS					SUMMARY
Study	Vaccine	Study Design	Participants	Summary of Key Findings	Level of Evidence	Quality
HPV024	Cervarix™	Open, multicentric study with 2 treatment groups (4 dose – HPV-4D vs 3 dose—HPV-3D) To assess the immunogenicity and safety of a 4th HPV dose in young adult women	Females 10 years of age and older Mean age: 27years n=115	6.8 years after the initial 3-dose vaccination course, all subjects in the HPV-4D Group were seropositive for both HPV-16 (GMT value = 720.7) and HPV-18 antibodies (GMT value = 502.9). In the HPV-3D Group, prior to the first vaccination, 28.9% and 26.7% of subjects were seropositive for antibodies against HPV 16 (GMT value = 8.6) and HPV-18 (GMT value =5.9), respectively (natural infection). Seven days after the fourth dose, all subjects in the HPV 4D Group were seropositive for antibodies against HPV-16 (GMT value = 5894.9) and HPV-18 (GMT value = 3916.2). One month after receiving a 4th dose of the HPV vaccine, all subjects in the HPV-4D Group were seropositive for antibodies against HPV-16 (GMT value = 15410.7) and HPV-18 (GMT value = 8362.7). Seven days after the first dose, 66.7% and 57.8% of subjects in the HPV 3D were seropositive for antibodies against HPV-16 (GMT value = 67.9) and HPV-18 (GMT value = 20.7), respectively. One month after the first dose, all subjects in that group were seropositive for antibodies against both antigens (GMT value for HPV-16 = 1231.1 and for HPV-18 = 442.0). During the post vaccination follow-up period, 24 (36.9%) subjects in HPV-4D Group and 25 (50.0%) subjects in HPV-3D Group reported unsolicited AEs.	Level II-1	Assessment pending peer-reviewed publication