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Article: Evaluation of quadrivalent HPV 6/11/16/18 vaccine efficacy against cervical and anogenital disease in subjects with serological evidence of prior vaccine type HPV infection

TitleEvaluation of quadrivalent HPV 6/11/16/18 vaccine efficacy against cervical and anogenital disease in subjects with serological evidence of prior vaccine type HPV infection
Authors
KeywordsCervical cancer
HPV
Vaccine
Issue Date2009
PublisherLandes Bioscience. The Journal's web site is located at http://www.landesbioscience.com/journals/vaccines/
Citation
Human Vaccines, 2009, v. 5 n. 10, p. 696-704 How to Cite?
AbstractObjective: In the quadrivalent (types 6/11/16/18) HPV vaccine (GARDASIL®/SILGARD®) clinical program, 73% of women aged 16-26 were naïve to all vaccine HPV types. In these women, prophylactic administration of the vaccine was highly effective in preventing HPV 6/11/16/18-related cervical disease. Of the remaining women, 15% of had evidence of past infection with one or more vaccine HPV types (seropositive and DNA negative) at the time of enrollment. Here we present an analysis in this group of women to determine the efficacy of the HPV 6/11/16/18 vaccine against new cervical and external anogenital disease related to the same vaccine HPV type which had previously been cleared. Vaccine tolerability in this previously infected population was also assessed. Results: Subjects were followed for an average of 40 months. Seven subjects in the placebo group developed cervical disease, and eight subjects developed external genital disease related to a vaccine HPV type they had previously encountered. No subject receiving HPV 6/11/16/18 vaccine developed disease to a vaccine HPV type to which they were seropositive and DNA negative at enrollment. Methods: 18,174 women were enrolled into three clinical studies. The data presented comprise a subset of these subjects (n = 2,617) who were HPV seropositive and DNA negative at enrollment (for ≥1 vaccine type). In each study, subjects were randomized in a 1:1 ratio to receive HPV 6/11/16/18 vaccine or placebo at day 1, month 2 and month 6 (without knowledge of baseline HPV status). Procedures performed for efficacy data evaluation included detailed genital examination, Pap testing and collection of cervicovaginal and external genital specimens. Analyses of efficacy were carried out in a population stratified by HPV serology and HPV DNA status at enrollment. Conclusions: These results suggest that natural HPV infection-elicited antibodies may not provide complete protection over time, however the immune response to the HPV 6/11/16/18 vaccine appears to prevent reinfection or reactivation of disease with vaccine HPV types. Vaccine-related adverse experiences were higher among subjects receiving vaccine, mostly due to increased injection site adverse experiences. © 2009 Landes Bioscience.
Persistent Identifierhttp://hdl.handle.net/10722/125630
ISSN
2013 Impact Factor: 3.643
2014 SCImago Journal Rankings: 0.974
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorOlsson, SEen_HK
dc.contributor.authorKjaer, SKen_HK
dc.contributor.authorSigurdsson, Ken_HK
dc.contributor.authorIversen, OEen_HK
dc.contributor.authorHernandezAvila, Men_HK
dc.contributor.authorWheeler, CMen_HK
dc.contributor.authorPerez, Gen_HK
dc.contributor.authorBrown, DRen_HK
dc.contributor.authorKoutsky, LAen_HK
dc.contributor.authorTay, EHen_HK
dc.contributor.authorGarcía, Pen_HK
dc.contributor.authorAult, KAen_HK
dc.contributor.authorGarland, SMen_HK
dc.contributor.authorLeodolter, Sen_HK
dc.contributor.authorTang, GWKen_HK
dc.contributor.authorFerris, DGen_HK
dc.contributor.authorPaavonen, Jen_HK
dc.contributor.authorLehtinen, Men_HK
dc.contributor.authorSteben, Men_HK
dc.contributor.authorBosch, FXen_HK
dc.contributor.authorDillner, Jen_HK
dc.contributor.authorJoura, EAen_HK
dc.contributor.authorMajewski, Sen_HK
dc.contributor.authorMuñoz, Nen_HK
dc.contributor.authorMyers, ERen_HK
dc.contributor.authorVilla, LLen_HK
dc.contributor.authorTaddeo, FJen_HK
dc.contributor.authorRoberts, Cen_HK
dc.contributor.authorTadesse, Aen_HK
dc.contributor.authorBryan, Jen_HK
dc.contributor.authorMaansson, Ren_HK
dc.contributor.authorVuocolo, Sen_HK
dc.contributor.authorHesley, TMen_HK
dc.contributor.authorSaah, Aen_HK
dc.contributor.authorBarr, Een_HK
dc.contributor.authorHaupt, RMen_HK
dc.date.accessioned2010-10-31T11:42:32Z-
dc.date.available2010-10-31T11:42:32Z-
dc.date.issued2009en_HK
dc.identifier.citationHuman Vaccines, 2009, v. 5 n. 10, p. 696-704en_HK
dc.identifier.issn1554-8600en_HK
dc.identifier.urihttp://hdl.handle.net/10722/125630-
dc.description.abstractObjective: In the quadrivalent (types 6/11/16/18) HPV vaccine (GARDASIL®/SILGARD®) clinical program, 73% of women aged 16-26 were naïve to all vaccine HPV types. In these women, prophylactic administration of the vaccine was highly effective in preventing HPV 6/11/16/18-related cervical disease. Of the remaining women, 15% of had evidence of past infection with one or more vaccine HPV types (seropositive and DNA negative) at the time of enrollment. Here we present an analysis in this group of women to determine the efficacy of the HPV 6/11/16/18 vaccine against new cervical and external anogenital disease related to the same vaccine HPV type which had previously been cleared. Vaccine tolerability in this previously infected population was also assessed. Results: Subjects were followed for an average of 40 months. Seven subjects in the placebo group developed cervical disease, and eight subjects developed external genital disease related to a vaccine HPV type they had previously encountered. No subject receiving HPV 6/11/16/18 vaccine developed disease to a vaccine HPV type to which they were seropositive and DNA negative at enrollment. Methods: 18,174 women were enrolled into three clinical studies. The data presented comprise a subset of these subjects (n = 2,617) who were HPV seropositive and DNA negative at enrollment (for ≥1 vaccine type). In each study, subjects were randomized in a 1:1 ratio to receive HPV 6/11/16/18 vaccine or placebo at day 1, month 2 and month 6 (without knowledge of baseline HPV status). Procedures performed for efficacy data evaluation included detailed genital examination, Pap testing and collection of cervicovaginal and external genital specimens. Analyses of efficacy were carried out in a population stratified by HPV serology and HPV DNA status at enrollment. Conclusions: These results suggest that natural HPV infection-elicited antibodies may not provide complete protection over time, however the immune response to the HPV 6/11/16/18 vaccine appears to prevent reinfection or reactivation of disease with vaccine HPV types. Vaccine-related adverse experiences were higher among subjects receiving vaccine, mostly due to increased injection site adverse experiences. © 2009 Landes Bioscience.en_HK
dc.languageengen_HK
dc.publisherLandes Bioscience. The Journal's web site is located at http://www.landesbioscience.com/journals/vaccines/en_HK
dc.relation.ispartofHuman Vaccinesen_HK
dc.subjectCervical canceren_HK
dc.subjectHPVen_HK
dc.subjectVaccineen_HK
dc.titleEvaluation of quadrivalent HPV 6/11/16/18 vaccine efficacy against cervical and anogenital disease in subjects with serological evidence of prior vaccine type HPV infectionen_HK
dc.typeArticleen_HK
dc.identifier.emailTang, GWK:gwktang@hkucc.hku.hken_HK
dc.identifier.authorityTang, GWK=rp00328en_HK
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.4161/hv.5.10.9515en_HK
dc.identifier.pmid19855170-
dc.identifier.scopuseid_2-s2.0-74049150705en_HK
dc.identifier.hkuros172094en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-74049150705&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume5en_HK
dc.identifier.issue10en_HK
dc.identifier.spage696en_HK
dc.identifier.epage704en_HK
dc.identifier.isiWOS:000273417500007-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridOlsson, SE=7202623557en_HK
dc.identifier.scopusauthoridKjaer, SK=7004418213en_HK
dc.identifier.scopusauthoridSigurdsson, K=35475355400en_HK
dc.identifier.scopusauthoridIversen, OE=7102966661en_HK
dc.identifier.scopusauthoridHernandezAvila, M=7005968193en_HK
dc.identifier.scopusauthoridWheeler, CM=7202505711en_HK
dc.identifier.scopusauthoridPerez, G=16307983600en_HK
dc.identifier.scopusauthoridBrown, DR=7407095050en_HK
dc.identifier.scopusauthoridKoutsky, LA=7006120337en_HK
dc.identifier.scopusauthoridTay, EH=7004902850en_HK
dc.identifier.scopusauthoridGarcía, P=7201693727en_HK
dc.identifier.scopusauthoridAult, KA=7005241226en_HK
dc.identifier.scopusauthoridGarland, SM=7102220459en_HK
dc.identifier.scopusauthoridLeodolter, S=7005056838en_HK
dc.identifier.scopusauthoridTang, GWK=7401633864en_HK
dc.identifier.scopusauthoridFerris, DG=17634377600en_HK
dc.identifier.scopusauthoridPaavonen, J=7102724434en_HK
dc.identifier.scopusauthoridLehtinen, M=35479268300en_HK
dc.identifier.scopusauthoridSteben, M=6602790643en_HK
dc.identifier.scopusauthoridBosch, FX=7201833375en_HK
dc.identifier.scopusauthoridDillner, J=7007135194en_HK
dc.identifier.scopusauthoridJoura, EA=7004817276en_HK
dc.identifier.scopusauthoridMajewski, S=7103224726en_HK
dc.identifier.scopusauthoridMuñoz, N=7102360543en_HK
dc.identifier.scopusauthoridMyers, ER=35433205900en_HK
dc.identifier.scopusauthoridVilla, LL=7102824355en_HK
dc.identifier.scopusauthoridTaddeo, FJ=6603004214en_HK
dc.identifier.scopusauthoridRoberts, C=35474924800en_HK
dc.identifier.scopusauthoridTadesse, A=6602812727en_HK
dc.identifier.scopusauthoridBryan, J=7202481712en_HK
dc.identifier.scopusauthoridMaansson, R=35146242700en_HK
dc.identifier.scopusauthoridVuocolo, S=16403558200en_HK
dc.identifier.scopusauthoridHesley, TM=6603486789en_HK
dc.identifier.scopusauthoridSaah, A=7006464069en_HK
dc.identifier.scopusauthoridBarr, E=7005643832en_HK
dc.identifier.scopusauthoridHaupt, RM=11940557600en_HK

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