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

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Fältnamn	Indikatorer	Metadata
000		04959naa a2200697 4500
001		oai:lup.lub.lu.se:cca9b4e9-38a1-4ccd-9d6a-c4791cf7b46a
003		SwePub
008		160401s2009 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
024	7	a https://lup.lub.lu.se/record/15467662 URI
040		a (SwePub)lu
041		a engb eng
042		9 SwePub
072	7	a art2 swepub-publicationtype
072	7	a ref2 swepub-contenttype
100	1	a Olsson, Sven-Eric4 aut
245	1 0	a 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
264	1	c 2009
520		a Objective: In the quadrivalent (types 6/11/16/18) HPV vaccine (GARDASIL (R)/SILGARD (R)) clinical program, 73% of women aged 16-26 were naive 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.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Mikrobiologi inom det medicinska området0 (SwePub)301092 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Microbiology in the medical area0 (SwePub)301092 hsv//eng
653		a vaccine
653		a HPV
653		a cervical cancer
700	1	a Kjaer, Susanne K.4 aut
700	1	a Sigurdsson, Kristjan4 aut
700	1	a Iversen, Ole-Erik4 aut
700	1	a Hernandez-Avila, Mauricio4 aut
700	1	a Wheeler, Cosette M.4 aut
700	1	a Perez, Gonzalo4 aut
700	1	a Brown, Darron R.4 aut
700	1	a Koutsky, Laura A.4 aut
700	1	a Tay, Eng Hseon4 aut
700	1	a Garcia, Patricia4 aut
700	1	a Ault, Kevin A.4 aut
700	1	a Garland, Suzanne M.4 aut
700	1	a Leodolter, Sepp4 aut
700	1	a Tang, Grace W. K.4 aut
700	1	a Ferris, Daron G.4 aut
700	1	a Paavonen, Jorma4 aut
700	1	a Lehtinen, Matti4 aut
700	1	a Steben, Marc4 aut
700	1	a Bosch, F. Xavier4 aut
700	1	a Dillner, Joakimu Lund University,Lunds universitet,Klinisk mikrobiologi, Malmö,Forskargrupper vid Lunds universitet,Clinical Microbiology, Malmö,Lund University Research Groups4 aut0 (Swepub:lu)mikr-jdi
700	1	a Joura, Elmar A.4 aut
700	1	a Majewski, Slawomir4 aut
700	1	a Munoz, Nubia4 aut
700	1	a Myers, Evan R.4 aut
700	1	a Villa, Luisa L.4 aut
700	1	a Taddeo, Frank J.4 aut
700	1	a Roberts, Christine4 aut
700	1	a Tadesse, Amha4 aut
700	1	a Bryan, Janine4 aut
700	1	a Maansson, Roger4 aut
700	1	a Vuocolo, Scott4 aut
700	1	a Hesley, Teresa M.4 aut
700	1	a Saah, Alfred4 aut
700	1	a Barr, Eliav4 aut
700	1	a Haupt, Richard M.4 aut
710	2	a Klinisk mikrobiologi, Malmöb Forskargrupper vid Lunds universitet4 org
773	0	t Human Vaccinesg 5:10, s. 696-704q 5:10<696-704x 1554-8600
856	4 8	u https://lup.lub.lu.se/record/1546766

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