Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine

"The primary objective of this report is to describe the detection of adenocarcinoma in situ (AIS) and associated human papillomavirus (HPV) type distribution that was observed in the context of two phase 3 clinical trials of a quadrivalent HPV6/11/16/18 vaccine. In this intention-to-treat anal...

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Autores Principales: Ault K.A., Joura E.A., Kjaer S.K., Iversen O.-E., Wheeler C.M., Perez G., Brown D.R., Koutsky L.A., Garland S.M., Olsson S.-E., Tang G.W.K., Ferris D.G., Paavonen J., Steben M., Bosch F.X., Majewski S., Muñoz N., Sings H.L., Harkins K., Rutkowski M.A., Haupt R.M., Garner E.I.O.
Formato: Artículo (Article)
Lenguaje:Inglés (English)
Publicado: 2011
Materias:
Acceso en línea:https://repository.urosario.edu.co/handle/10336/24337
https://doi.org/10.1002/ijc.25723
id ir-10336-24337
recordtype dspace
spelling ir-10336-243372020-06-03T22:15:18Z Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine Ault K.A. Joura E.A. Kjaer S.K. Iversen O.-E. Wheeler C.M. Perez G. Brown D.R. Koutsky L.A. Garland S.M. Olsson S.-E. Tang G.W.K. Ferris D.G. Paavonen J. Steben M. Bosch F.X. Majewski S. Muñoz N. Sings H.L. Harkins K. Rutkowski M.A. Haupt R.M. Garner E.I.O. "Placebo Wart virus vaccine Adenocarcinoma in situ Adolescent Adult Article Carcinoma in situ Colposcopy Cytology Disease association Double blind procedure Drug efficacy Drug safety Ethnicity Female Human Human papillomavirus type 11 Human papillomavirus type 16 Human papillomavirus type 18 Human papillomavirus type 6 Human tissue Major clinical study Multicenter study Nonhuman Papillomavirus infection Phase 3 clinical trial Polymerase chain reaction Priority journal Randomized controlled trial Uterine cervix biopsy Uterine cervix carcinoma in situ Adenocarcinoma Adolescent Adult Cervical intraepithelial neoplasia Colposcopy Dna, viral Double-blind method Female Follow-up studies Humans Papillomaviridae Papillomavirus infections Papillomavirus vaccines Prognosis Uterine cervical neoplasms Vaginal smears Young adult Adenocarcinoma in situ (ais) Human papillomavirus (hpv) Natural history Vaccine" "The primary objective of this report is to describe the detection of adenocarcinoma in situ (AIS) and associated human papillomavirus (HPV) type distribution that was observed in the context of two phase 3 clinical trials of a quadrivalent HPV6/11/16/18 vaccine. In this intention-to-treat analysis, we include all women who had at least one follow-up visit postenrollment. Healthy women (17,622) aged 15-26 with no history of HPV disease and a lifetime number of less than five sex partners (average follow-up of 3.6 years) were randomized (1:1) to receive vaccine or placebo at day 1, months 2, and 6. Women underwent colposcopy and biopsy according to a Papanicolaou triage algorithm. All tissue specimens were tested for 14 HPV types and were adjudicated by a pathology panel. During the trials, 22 women were diagnosed with AIS (six vaccine and 16 placebo). There were 25 AIS lesions in total, with HPV16/18 present in 96% (24 of 25 with 15 of 25 as single infections). Only two of 22 women had concomitant cytology results suggesting glandular abnormality. Colposcopic impressions (25 total) were either negative or indicated squamous lesions only. Of women with AIS, all six in the vaccine cohort and seven of 16 in the placebo cohort were infected at baseline with the same HPV type that was detected in the AIS lesion. Concurrent squamous lesions were detected in 20 of these 22 women. In summary, our findings show that AIS evades colposcopic and cervical cytologic detection. As most AIS lesions were HPV16/18-related, prophylactic HPV vaccination should reduce the incidence of invasive adenocarcinoma. Copyright © 2011 UICC." 2011 2020-05-26T00:11:51Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion 00207136 10970215 https://repository.urosario.edu.co/handle/10336/24337 https://doi.org/10.1002/ijc.25723 eng info:eu-repo/semantics/openAccess application/pdf instname:Universidad del Rosario reponame:Repositorio Institucional EdocUR
institution EdocUR - Universidad del Rosario
collection DSpace
language Inglés (English)
topic "Placebo
Wart virus vaccine
Adenocarcinoma in situ
Adolescent
Adult
Article
Carcinoma in situ
Colposcopy
Cytology
Disease association
Double blind procedure
Drug efficacy
Drug safety
Ethnicity
Female
Human
Human papillomavirus type 11
Human papillomavirus type 16
Human papillomavirus type 18
Human papillomavirus type 6
Human tissue
Major clinical study
Multicenter study
Nonhuman
Papillomavirus infection
Phase 3 clinical trial
Polymerase chain reaction
Priority journal
Randomized controlled trial
Uterine cervix biopsy
Uterine cervix carcinoma in situ
Adenocarcinoma
Adolescent
Adult
Cervical intraepithelial neoplasia
Colposcopy
Dna, viral
Double-blind method
Female
Follow-up studies
Humans
Papillomaviridae
Papillomavirus infections
Papillomavirus vaccines
Prognosis
Uterine cervical neoplasms
Vaginal smears
Young adult
Adenocarcinoma in situ (ais)
Human papillomavirus (hpv)
Natural history
Vaccine"
spellingShingle "Placebo
Wart virus vaccine
Adenocarcinoma in situ
Adolescent
Adult
Article
Carcinoma in situ
Colposcopy
Cytology
Disease association
Double blind procedure
Drug efficacy
Drug safety
Ethnicity
Female
Human
Human papillomavirus type 11
Human papillomavirus type 16
Human papillomavirus type 18
Human papillomavirus type 6
Human tissue
Major clinical study
Multicenter study
Nonhuman
Papillomavirus infection
Phase 3 clinical trial
Polymerase chain reaction
Priority journal
Randomized controlled trial
Uterine cervix biopsy
Uterine cervix carcinoma in situ
Adenocarcinoma
Adolescent
Adult
Cervical intraepithelial neoplasia
Colposcopy
Dna, viral
Double-blind method
Female
Follow-up studies
Humans
Papillomaviridae
Papillomavirus infections
Papillomavirus vaccines
Prognosis
Uterine cervical neoplasms
Vaginal smears
Young adult
Adenocarcinoma in situ (ais)
Human papillomavirus (hpv)
Natural history
Vaccine"
Ault K.A.
Joura E.A.
Kjaer S.K.
Iversen O.-E.
Wheeler C.M.
Perez G.
Brown D.R.
Koutsky L.A.
Garland S.M.
Olsson S.-E.
Tang G.W.K.
Ferris D.G.
Paavonen J.
Steben M.
Bosch F.X.
Majewski S.
Muñoz N.
Sings H.L.
Harkins K.
Rutkowski M.A.
Haupt R.M.
Garner E.I.O.
Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine
description "The primary objective of this report is to describe the detection of adenocarcinoma in situ (AIS) and associated human papillomavirus (HPV) type distribution that was observed in the context of two phase 3 clinical trials of a quadrivalent HPV6/11/16/18 vaccine. In this intention-to-treat analysis, we include all women who had at least one follow-up visit postenrollment. Healthy women (17,622) aged 15-26 with no history of HPV disease and a lifetime number of less than five sex partners (average follow-up of 3.6 years) were randomized (1:1) to receive vaccine or placebo at day 1, months 2, and 6. Women underwent colposcopy and biopsy according to a Papanicolaou triage algorithm. All tissue specimens were tested for 14 HPV types and were adjudicated by a pathology panel. During the trials, 22 women were diagnosed with AIS (six vaccine and 16 placebo). There were 25 AIS lesions in total, with HPV16/18 present in 96% (24 of 25 with 15 of 25 as single infections). Only two of 22 women had concomitant cytology results suggesting glandular abnormality. Colposcopic impressions (25 total) were either negative or indicated squamous lesions only. Of women with AIS, all six in the vaccine cohort and seven of 16 in the placebo cohort were infected at baseline with the same HPV type that was detected in the AIS lesion. Concurrent squamous lesions were detected in 20 of these 22 women. In summary, our findings show that AIS evades colposcopic and cervical cytologic detection. As most AIS lesions were HPV16/18-related, prophylactic HPV vaccination should reduce the incidence of invasive adenocarcinoma. Copyright © 2011 UICC."
format Artículo (Article)
author Ault K.A.
Joura E.A.
Kjaer S.K.
Iversen O.-E.
Wheeler C.M.
Perez G.
Brown D.R.
Koutsky L.A.
Garland S.M.
Olsson S.-E.
Tang G.W.K.
Ferris D.G.
Paavonen J.
Steben M.
Bosch F.X.
Majewski S.
Muñoz N.
Sings H.L.
Harkins K.
Rutkowski M.A.
Haupt R.M.
Garner E.I.O.
author_facet Ault K.A.
Joura E.A.
Kjaer S.K.
Iversen O.-E.
Wheeler C.M.
Perez G.
Brown D.R.
Koutsky L.A.
Garland S.M.
Olsson S.-E.
Tang G.W.K.
Ferris D.G.
Paavonen J.
Steben M.
Bosch F.X.
Majewski S.
Muñoz N.
Sings H.L.
Harkins K.
Rutkowski M.A.
Haupt R.M.
Garner E.I.O.
author_sort Ault K.A.
title Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine
title_short Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine
title_full Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine
title_fullStr Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine
title_full_unstemmed Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine
title_sort adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine
publishDate 2011
url https://repository.urosario.edu.co/handle/10336/24337
https://doi.org/10.1002/ijc.25723
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