Sustained Immunogenicity of 2-dose Human Papillomavirus 16/18 AS04-adjuvanted Vaccine Schedules in Girls Aged 9-14 Years: A Randomized Trial

Li Min Huang, Thanyawee Puthanakit, Chiu Cheng-Hsun, Tang Ren-Bin, Tino Schwarz, Angelo Pellegrino, Susanna Esposito, Louise Frenette, Shelly McNeil, Paolo Durando, Paul Rheault, Carlo Giaquinto, Michael Horn, Karl Ulrich Petry, Klaus Peters, Toma Azhar, Peter Hillemanns, Stephanie De Simoni, Damien Friel, Suryakiran PemmarajuMarjan Hezareh, Florence Thomas, Dominique Descamps, Nicolas Folschweiller, Frank Struyf

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1711-1719
Number of pages9
JournalThe Journal of infectious diseases
Volume215
Issue number11
DOIs
Publication statusPublished - Jun 1 2017

Keywords

  • 2-dose schedule
  • Cervarix
  • cervical cancer
  • human papillomavirus (HPV)

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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