LI-MIN HUANGPuthanakit T.Cheng-Hsun C.Ren-Bin T.Schwarz T.Pellegrino A.Esposito S.Frenette L.McNeil S.Durando P.Rheault P.Giaquinto C.Horn M.Petry K.U.Peters K.Azhar T.Hillemanns P.De Simoni S.Friel D.Pemmaraju S.Hezareh M.Thomas F.Descamps D.Folschweiller N.Struyf F.2021-06-242021-06-2420170022-1899https://www.scopus.com/inward/record.uri?eid=2-s2.0-85029152634&doi=10.1093%2finfdis%2fjix154&partnerID=40&md5=35fd27d4f49e650ba6ef2f677ed4822ahttps://scholars.lib.ntu.edu.tw/handle/123456789/566403Background. We previously reported the noninferiority 1 month after the last dose of 2-dose human papillomavirus 16/18 AS04-adjuvanted (AS04-HPV-16/18) vaccine schedules at months 0 and 6 (2D-M0, 6) and months 0 and 12 (2D-M0, 12) in girls aged 9-14 years compared with a 3-dose schedule at months 0, 1, and 6 (3D-M0, 1, 6) in women aged 15-25 years. Here, we report the results at study end (month 36 [M36]). Methods. Girls were randomized 1: 1 and received 2 vaccine doses either 6 months (2D-M0, 6) or 12 months apart (2D-M0, 12); women received 3 doses at months 0, 1, and 6 (3D-M0, 1, 6). Endpoints included noninferiority of HPV-16/18 antibodies for 2D- M0, 6 versus 3D-M0, 1, 6; 2D-M0, 12 versus 3D-M0, 1, 6; and 2D-M0, 12 versus 2D-M0, 6; and assessment of neutralizing antibodies, T cells, B cells, and safety. Results. At M36, the 2D-M0, 6 and 2D-M0, 12 schedules remained noninferior to the 3D-M0, 1, 6 schedule in terms of seroconversion rates and 3D/2D geometric mean titers for anti-HPV-16 and anti-HPV-18. All schedules elicited sustained immune responses up to M36. Conclusions. Both 2-dose schedules in young girls remained noninferior to the 3-dose schedule in women up to study conclusion at M36. The AS04-HPV-16/18 vaccine administered as a 2-dose schedule was immunogenic and well tolerated in young girls. ? The Author 2017.2-dose schedule; Cervarix; Cervical cancer; Human papillomavirus (HPV)[SDGs]SDG3[SDGs]SDG5neutralizing antibody; Wart virus vaccine; aluminum hydroxide; ASO4 mixture; human papillomavirus vaccine, L1 type 16, 18; lipid A; virus antibody; Wart virus vaccine; adolescent; antibody titer; Article; B lymphocyte; child; controlled study; dosage schedule comparison; drug dose regimen; drug safety; drug tolerability; drug withdrawal; female; human; Human papillomavirus type 16; Human papillomavirus type 18; immune response; immunogenicity; major clinical study; multicenter study; open study; papillomavirus infection; phase 3 clinical trial; priority journal; randomized controlled trial; seroconversion; systemic lupus erythematosus; T lymphocyte; vaccination; analogs and derivatives; blood; immunology; Adolescent; Aluminum Hydroxide; Antibodies, Viral; Child; Female; Human papillomavirus 16; Human papillomavirus 18; Humans; Lipid A; Papillomavirus Vaccinesjournal article10.1093/infdis/jix154285917782-s2.0-85029152634