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
- Creators
- Puthanakit, Thanyawee
- Huang, Li Min
- Chiu, Cheng Hsun
- Tang, Ren Bin
- Schwarz, Tino F.
- Esposito, Susanna
- Frenette, Louise
- Giaquinto, Carlo
- Mcneil, Shelly
- Rheault, Paul
- DURANDO, PAOLO
- Horn, Michael
- Klar, Maximilian
- Poncelet, Sylviane
- De Simoni, Stéphanie
- Friel, Damien
- De Muynck, Benoit
- Suryakiran, Pemmaraju V.
- Hezareh, Marjan
- Descamps, Dominique
- Thomas, Florence
- Struyf, Frank
- Others:
- Puthanakit, Thanyawee
- Huang, Li Min
- Chiu, Cheng Hsun
- Tang, Ren Bin
- Schwarz, Tino F.
- Esposito, Susanna
- Frenette, Louise
- Giaquinto, Carlo
- Mcneil, Shelly
- Rheault, Paul
- Durando, Paolo
- Horn, Michael
- Klar, Maximilian
- Poncelet, Sylviane
- De Simoni, Stéphanie
- Friel, Damien
- De Muynck, Benoit
- Suryakiran, Pemmaraju V.
- Hezareh, Marjan
- Descamps, Dominique
- Thomas, Florence
- Struyf, Frank
Description
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.
Additional details
- URL
- http://hdl.handle.net/11567/846766
- URN
- urn:oai:iris.unige.it:11567/846766
- Origin repository
- UNIGE