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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
Chinese Univ Hong Kong, Dept Paediat, Shatin, Hong Kong, Peoples R China..
Univ Hong Kong, Li Ka Shing Fac Med, Dept Paediat & Adolescent Med, Hong Kong, Hong Kong, Peoples R China..
Natl Healthcare Grp Polyclin, Singapore, Singapore.;Natl Univ Singapore, Singapore, Singapore..
AFPA, Esseys Les Nancy, France..
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2018 (English)In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 36, no 1, p. 98-106Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
ELSEVIER SCI LTD , 2018. Vol. 36, no 1, p. 98-106
Keywords [en]
Human papillomavirus vaccines, Administration schedule, Female adolescents, Immunogenicity, Safety
National Category
Immunology in the medical area
Identifiers
URN: urn:nbn:se:uu:diva-341304DOI: 10.1016/j.vaccine.2017.11.034ISI: 000419411400015PubMedID: 29174109OAI: oai:DiVA.org:uu-341304DiVA, id: diva2:1181926
Funder
GlaxoSmithKline (GSK)Available from: 2018-02-12 Created: 2018-02-12 Last updated: 2018-02-12Bibliographically approved

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