TY - JOUR
T1 - Sustained immunogenicity of 2-dose human papillomavirus 16/18 AS04-adjuvanted vaccine schedules in girls aged 9-14 years
T2 - A randomized trial
AU - Huang, Li Min
AU - Puthanakit, Thanyawee
AU - Cheng-Hsun, Chiu
AU - Ren-Bin, Tang
AU - Schwarz, Tino
AU - Pellegrino, Angelo
AU - Esposito, Susanna
AU - Frenette, Louise
AU - McNeil, Shelly
AU - Durando, Paolo
AU - Rheault, Paul
AU - Giaquinto, Carlo
AU - Horn, Michael
AU - Petry, Karl Ulrich
AU - Peters, Klaus
AU - Azhar, Toma
AU - Hillemanns, Peter
AU - De Simoni, Stephanie
AU - Friel, Damien
AU - Pemmaraju, Suryakiran
AU - Hezareh, Marjan
AU - Thomas, Florence
AU - Descamps, Dominique
AU - Folschweiller, Nicolas
AU - Struyf, Frank
N1 - Publisher Copyright:
© The Author 2017.
PY - 2017/6/1
Y1 - 2017/6/1
N2 - Background. 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.
AB - Background. 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.
KW - 2-dose schedule
KW - Cervarix
KW - Cervical cancer
KW - Human papillomavirus (HPV)
UR - https://www.scopus.com/pages/publications/85029152634
U2 - 10.1093/infdis/jix154
DO - 10.1093/infdis/jix154
M3 - 文章
C2 - 28591778
AN - SCOPUS:85029152634
SN - 0022-1899
VL - 215
SP - 1711
EP - 1719
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 11
ER -
