A randomised open trial comparing 2-dose regimens of the HPV-16/18 AS04-adjuvanted vaccine in girls aged 9-14 years versus 3 doses in women aged 15-25 years
Articolo
Data di Pubblicazione:
2016
Citazione:
A randomised open trial comparing 2-dose regimens of the HPV-16/18 AS04-adjuvanted vaccine in girls aged 9-14 years versus 3 doses in women aged 15-25 years / T. Puthanakit, L. Huang, C. Chiu, R. Tang, T.F. Schwarz, S. Esposito, L. Frenette, C. Giaquinto, S. Mcneil, P. Rheault, P. Durando, M. Horn, M. Klar, S. Poncelet, S. De Simoni, D. Friel, B. De Muynck, P.V. Suryakiran, M. Hezareh, D. Descamps, F. Thomas, F. Struyf. - In: THE JOURNAL OF INFECTIOUS DISEASES. - ISSN 0022-1899. - 214:4(2016 Aug 15), pp. 525-536. [10.1093/infdis/jiw036]
Abstract:
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.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
2-dose schedule; AS04; Adjuvant System containing 50 µg 3-O-desacyl-4′-monophosphoryl lipid A (MPL) adsorbed on aluminum salt (500 µg Al3+); CMI; GMT; HPV; IgG; cell-mediated immunity; cervical cancer; geometric mean antibody titer; human papillomavirus; immunogenicity
Elenco autori:
T. Puthanakit, L. Huang, C. Chiu, R. Tang, T.F. Schwarz, S. Esposito, L. Frenette, C. Giaquinto, S. Mcneil, P. Rheault, P. Durando, M. Horn, M. Klar, S. Poncelet, S. De Simoni, D. Friel, B. De Muynck, P.V. Suryakiran, M. Hezareh, D. Descamps, F. Thomas, F. Struyf
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