TY - JOUR
T1 - Randomized open trial comparing 2-dose regimens of the human papillomavirus 16/18 as04-adjuvanted vaccine in girls aged 9-14 years versus a 3-dose regimen in women aged 15-25 years
AU - Puthanakit, Thanyawee
AU - Huang, Li Min
AU - Chiu, Cheng Hsun
AU - Tang, Ren Bin
AU - Schwarz, Tino F.
AU - Esposito, Susanna
AU - Frenette, Louise
AU - Giaquinto, Carlo
AU - McNeil, Shelly
AU - Rheault, Paul
AU - Durando, Paolo
AU - Horn, Michael
AU - Klar, Maximilian
AU - Poncelet, Sylviane
AU - De Simoni, Stéphanie
AU - Friel, Damien
AU - De Muynck, Benoit
AU - Suryakiran, Pemmaraju V.
AU - Hezareh, Marjan
AU - Descamps, Dominique
AU - Thomas, Florence
AU - Struyf, Frank
N1 - Publisher Copyright:
© The Author 2016.
PY - 2016/8/15
Y1 - 2016/8/15
N2 - Background. This randomized, open trial compared regimens including 2 doses (2D) of human papillomavirus (HPV) 16/18 AS04-adjuvanted vaccine in girls aged 9-14 years with one including 3 doses (3D) in women aged 15-25 years. Methods. Girls aged 9-14 years were randomized to receive 2D at months 0 and 6 (M0,6; (n = 550) or months 0 and 12 (M0,12; n = 415), and women aged 15-25 years received 3D at months 0, 1, and 6 (n = 482). End points included noninferiority of HPV-16/ 18 antibodies by enzyme-linked immunosorbent assay for 2D (M0,6) versus 3D (primary), 2D (M0,12) versus 3D, and 2D (M0,6) versus 2D (M0,12); neutralizing antibodies; cell-mediated immunity; reactogenicity; and safety. Limits of noninferiority were predefined as <5% difference in seroconversion rate and <2-fold difference in geometric mean antibody titer ratio. Results. One month after the last dose, both 2D regimens in girls aged 9-14 years were noninferior to 3D in women aged 15-25 years and 2D (M0,12) was noninferior to 2D (M0,6). Geometric mean antibody titer ratios (3D/2D) for HPV-16 and HPV-18 were 1.09 (95% confidence interval, .97-1.22) and 0.85 (.76-.95) for 2D (M0,6) versus 3D and 0.89 (.79-1.01) and 0.75 (.67-.85) for 2D (M0,12) versus 3D. The safety profile was clinically acceptable in all groups. Conclusions. The 2D regimens for the HPV-16/18 AS04-adjuvanted vaccine in girls aged 9-14 years (M0,6 or M0,12) elicited HPV-16/18 immune responses that were noninferior to 3D in women aged 15-25 years.
AB - Background. This randomized, open trial compared regimens including 2 doses (2D) of human papillomavirus (HPV) 16/18 AS04-adjuvanted vaccine in girls aged 9-14 years with one including 3 doses (3D) in women aged 15-25 years. Methods. Girls aged 9-14 years were randomized to receive 2D at months 0 and 6 (M0,6; (n = 550) or months 0 and 12 (M0,12; n = 415), and women aged 15-25 years received 3D at months 0, 1, and 6 (n = 482). End points included noninferiority of HPV-16/ 18 antibodies by enzyme-linked immunosorbent assay for 2D (M0,6) versus 3D (primary), 2D (M0,12) versus 3D, and 2D (M0,6) versus 2D (M0,12); neutralizing antibodies; cell-mediated immunity; reactogenicity; and safety. Limits of noninferiority were predefined as <5% difference in seroconversion rate and <2-fold difference in geometric mean antibody titer ratio. Results. One month after the last dose, both 2D regimens in girls aged 9-14 years were noninferior to 3D in women aged 15-25 years and 2D (M0,12) was noninferior to 2D (M0,6). Geometric mean antibody titer ratios (3D/2D) for HPV-16 and HPV-18 were 1.09 (95% confidence interval, .97-1.22) and 0.85 (.76-.95) for 2D (M0,6) versus 3D and 0.89 (.79-1.01) and 0.75 (.67-.85) for 2D (M0,12) versus 3D. The safety profile was clinically acceptable in all groups. Conclusions. The 2D regimens for the HPV-16/18 AS04-adjuvanted vaccine in girls aged 9-14 years (M0,6 or M0,12) elicited HPV-16/18 immune responses that were noninferior to 3D in women aged 15-25 years.
KW - 2-dose schedule
KW - AS04
KW - Adjuvant System containing 50 ?g 3-O-desacyl-4?-monophosphoryl lipid A (MPL) adsorbed on aluminum salt (500 ?g Al3+)
KW - CMI
KW - Cell-mediated immunity
KW - Cervical cancer
KW - GMT
KW - Geometric mean antibody titer
KW - HPV
KW - Human papillomavirus
KW - IgG
KW - Immunogenicity
UR - https://www.scopus.com/pages/publications/84988975003
U2 - 10.1093/infdis/jiw036
DO - 10.1093/infdis/jiw036
M3 - 文章
C2 - 26908726
AN - SCOPUS:84988975003
SN - 0022-1899
VL - 214
SP - 525
EP - 536
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 4
ER -
