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Article: 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

TitleComparative 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
Authors
KeywordsHuman papillomavirus vaccines
Administration schedule
Female adolescents
Immunogenicity
Safety
Issue Date2018
PublisherElsevier Ltd. The Journal's web site is located at http://www.elsevier.com/locate/vaccine
Citation
Vaccine, 2018, v. 36 n. 1, p. 98-106 How to Cite?
AbstractThis 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 M0, 6 (N = 358) or 3D of 4vHPV at M0, 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. Clinical Trial Registration: NCT0146235.
Persistent Identifierhttp://hdl.handle.net/10722/287697
ISSN
2023 Impact Factor: 4.5
2023 SCImago Journal Rankings: 1.342
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorLeung, TF-
dc.contributor.authorLiu, APY-
dc.contributor.authorLim, FS-
dc.contributor.authorThollot, F-
dc.contributor.authorOh, HML-
dc.contributor.authorLee, BW-
dc.contributor.authorRombo, L-
dc.contributor.authorTan, NC-
dc.contributor.authorRouzier, R-
dc.contributor.authorDe Simon, S-
dc.contributor.authorSuryakiran, P-
dc.contributor.authorHezareh, M-
dc.contributor.authorThomas, F-
dc.contributor.authorFolschweiller, N-
dc.contributor.authorStruyf, F-
dc.date.accessioned2020-10-05T12:01:56Z-
dc.date.available2020-10-05T12:01:56Z-
dc.date.issued2018-
dc.identifier.citationVaccine, 2018, v. 36 n. 1, p. 98-106-
dc.identifier.issn0264-410X-
dc.identifier.urihttp://hdl.handle.net/10722/287697-
dc.description.abstractThis 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 M0, 6 (N = 358) or 3D of 4vHPV at M0, 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. Clinical Trial Registration: NCT0146235.-
dc.languageeng-
dc.publisherElsevier Ltd. The Journal's web site is located at http://www.elsevier.com/locate/vaccine-
dc.relation.ispartofVaccine-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectHuman papillomavirus vaccines-
dc.subjectAdministration schedule-
dc.subjectFemale adolescents-
dc.subjectImmunogenicity-
dc.subjectSafety-
dc.titleComparative 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-
dc.typeArticle-
dc.identifier.emailLiu, APY: apyliu@hku.hk-
dc.identifier.authorityLiu, APY=rp01357-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1016/j.vaccine.2017.11.034-
dc.identifier.pmid29174109-
dc.identifier.scopuseid_2-s2.0-85035014240-
dc.identifier.hkuros315675-
dc.identifier.volume36-
dc.identifier.issue1-
dc.identifier.spage98-
dc.identifier.epage106-
dc.identifier.isiWOS:000419411400015-
dc.publisher.placeUnited Kingdom-
dc.identifier.issnl0264-410X-

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