Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: Results from two randomized trials
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- 作者：Pierre Van Dammea ; pierre.vandamme@ua.ac.be" class="auth_mail ; Geert Leroux-Roelsb ; geert.lerouxroels@ugent.be" class="auth_mail ; Philippe Simonc ; philippe.simon@erasme.ulb.ac.be" class="auth_mail ; Jean-Michel Foidartd ; 1 ; jmfoidart@ulg.ac.be" class="auth_mail ; Gilbert Donderse ; 2 ; gilbert.donders@femicare.net" class="auth_mail ; Karel Hoppenbrouwersf ; karel.hoppenbrouwers@med.kuleuven.be" class="auth_mail ; Myron Leving ; Myron.Levin@ucdenver.edu" class="auth_mail ; Fabian Tibaldih ; fabian.s.tibaldi@gsk.com" class="auth_mail ; Sylviane Ponceleth ; sylviane.poncelet@gsk.com" class="auth_mail ; Philippe Morish ; philippe.moris@gsk.com" class="auth_mail ; Francis Dessyi ; francis.dessy@gsk.com" class="auth_mail ; Sandra L. Gianninih ; sandra.giannini@gsk.com" class="auth_mail ; Dominique Descampsi ; dominique.descamps@gsk.com" class="auth_mail ; Gary Dubinj ; Gary.O.Dubin@gsk.com" class="auth_mail
- 关键词：AE ; adverse event ; ANOVA ; analysis of variance ; ATP ; according-to-protocol ; CD40L ; CD40 ligand ; CI ; confidence interval ; CIN ; cervical intraepithelial neoplasia ; Ctrl ; control ; ELISA ; enzyme-linked immunosorbent assay ; EU ; ELISA units ; GMT ; geometric mean antibody titer ; HPV ; human papillomavirus ; IFN ; interferon ; IL ; interleukin ; LU ; Luminex units ; M ; months ; MLIA ; multiplex Luminex immunoassay ; MPL ; 3-O-desacyl-4&prime ; -monophosphoryl lipid A ; No. ; number ; PBNA ; pseudovirion-based neutralizati
- 刊名：Vaccine
- 出版年：17 June 2014
- 年：2014
- 卷：32
- 期：29
- 页码：3694-3705
- 全文大小：901 K
文摘
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We evaluated the immunogenicity and safety of 2 tetravalent HPV vaccines.
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Immune responses were compared to the licensed bivalent HPV-16/18 L1 VLP vaccine.
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HPV-16 and -18 antibody titers were lower when additional HPV L1 VLPs were added.
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Immune interference was not always overcome by changing the VLP dose or adjuvant.
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All vaccine formulations had an acceptable reactogenicity and safety profile.