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Comparative immunog...
Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and 4vHPV vaccine administered according to two- or three-dose schedules in girls aged 9-14 years Results to month 36 from a randomized trial
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Leung, Ting Fan (författare)
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Liu, Anthony Pak-Yin (författare)
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Lim, Fong Seng (författare)
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visa fler...
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Thollot, Franck (författare)
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Oh, Helen May Lin (författare)
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Lee, Bee Wah (författare)
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Rombo, Lars (författare)
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Tan, Ngiap Chuan (författare)
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Rouzier, Roman (författare)
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De Simoni, Stephanie (författare)
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Suryakiran, Pemmaraju (författare)
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Hezareh, Marjan (författare)
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Thomas, Florence (författare)
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Folschweiller, Nicolas (författare)
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Struyf, Frank (författare)
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visa färre...
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(utgivare)
- ELSEVIER SCI LTD 2018
- 2018
- Engelska.
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Ingår i: Vaccine. - 0264-410X. ; 36:1, 98-106
Abstract
Ämnesord
Stäng
- This observer-blind study (clinicaltrials.gov NCT01462357) compared the immunogenicity and safety of two doses (2D) of the HPV-16/18 AS04-adjuvanted vaccine (2D of AS04-HPV-16/18) vs. two or three doses of the 4vHPV vaccine [2D or 3D of 4vHPV] in 1075 healthy girls aged 9-14 years. Girls were randomized (1:1:1) to receive 2D of AS04-HPV-16/18 at months (M) 0, 6 (N = 359), 2D of 4vHPV at MO, 6 (N = 358) or 3D of 4vHPV at MO, 2, 6 (N = 358). 351, 339 and 346 girls, respectively, returned for the concluding visit at M36. Superiority was demonstrated at M7 and M12; comparison of the immune response to both vaccine antigens was made between 2D of AS04-HPV-16/18 and 2D or 3D of 4vHPV at subsequent time points in the according-to-protocol immunogenicity cohort (ATP-I; N = 958 at M36) and the total vaccinated cohort (TVC: N = 1036 at M36). HPV-16/18-specific T-cell- and B-cell-mediated immune responses and safety were also investigated. At M36, anti-HPV-16/18 ELISA responses in the 2D AS04-HPV-16/18 group remained superior to those of the 2D and 3D 4vHPV groups. In the M36 TVC, geometric mean titers were 2.78-fold (HPV-16) and 6.84-fold (HPV-18) higher for 2D of AS04-HPV-16/18 vs. 2D of 4vHPV and 2.3-fold (HPV-16) and 4.14-fold (HPV-18) higher vs. 3D of 4vHPV. Results were confirmed by vaccine pseudovirion-based neutralisation assay. Numbers of circulating CD4(+) T cells and B cells appeared similar across groups. Safety was in line with the known safety profiles of both vaccines. In conclusion, superior HPV-16/18 antibody responses were elicited by 2D of the AS04-HPV-16/18 compared with 2D or 3D of the 4vHPV vaccine in girls aged 9-14 years.
Ämnesord
- Medical and Health Sciences (hsv)
- Basic Medicine (hsv)
- Immunology in the medical area (hsv)
- Medicin och hälsovetenskap (hsv)
- Medicinska och farmaceutiska grundvetenskaper (hsv)
- Immunologi inom det medicinska området (hsv)
Nyckelord
- Human papillomavirus vaccines
- Administration schedule
- Female adolescents
- Immunogenicity
- Safety
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Leung, Ting Fan
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Liu, Anthony Pak ...
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Lim, Fong Seng
-
Thollot, Franck
-
Oh, Helen May Li ...
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Lee, Bee Wah
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visa fler...
-
Rombo, Lars
-
Tan, Ngiap Chuan
-
Rouzier, Roman
-
De Simoni, Steph ...
-
Suryakiran, Pemm ...
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Hezareh, Marjan
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Thomas, Florence
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Folschweiller, N ...
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Struyf, Frank
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visa färre...
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