Sustained immunogenicity of 2-dose human papillomavirus 16/18 AS04-adjuvanted vaccine schedules in girls aged 9-14 years: A randomized trial
Journal
Journal of Infectious Diseases
Journal Volume
215
Journal Issue
11
Pages
1711-1719
Date Issued
2017
Author(s)
Puthanakit 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.
Abstract
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. ? The Author 2017.
Subjects
2-dose schedule; Cervarix; Cervical cancer; Human papillomavirus (HPV)
Other Subjects
neutralizing 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 Vaccines
Publisher
Oxford University Press
Type
journal article