Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Petersen, LK, Restrepo, J, Moreira, ED, Iversen, O-E, Pitisuttithum, P, Van Damme, P, Joura, EA, Olsson, S-E, Ferris, D, Block, S, Giuliano, AR, Bosch, X, Pils, S, Cuzick, J, Garland, SM, Huh, W, Kjaer, SK, Bautista, OM, Hyatt, D, Maansson, R, Moeller, E, Qi, H, Roberts, C & Luxembourg, A 2017, 'Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials' Papillomavirus research (Amsterdam, Netherlands), vol. 3, pp. 105-115. https://doi.org/10.1016/j.pvr.2017.03.002

APA

CBE

Petersen LK, Restrepo J, Moreira ED, Iversen O-E, Pitisuttithum P, Van Damme P, Joura EA, Olsson S-E, Ferris D, Block S, Giuliano AR, Bosch X, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Bautista OM, Hyatt D, Maansson R, Moeller E, Qi H, Roberts C, Luxembourg A. 2017. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus research (Amsterdam, Netherlands). 3:105-115. https://doi.org/10.1016/j.pvr.2017.03.002

MLA

Vancouver

Author

Petersen, Lone K ; Restrepo, Jaime ; Moreira, Edson D ; Iversen, Ole-Erik ; Pitisuttithum, Punnee ; Van Damme, Pierre ; Joura, Elmar A ; Olsson, Sven-Erik ; Ferris, Daron ; Block, Stan ; Giuliano, Anna R ; Bosch, Xavier ; Pils, Sophie ; Cuzick, Jack ; Garland, Suzanne M ; Huh, Warner ; Kjaer, Susanne K ; Bautista, Oliver M ; Hyatt, Donna ; Maansson, Roger ; Moeller, Erin ; Qi, Hong ; Roberts, Christine ; Luxembourg, Alain. / Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. In: Papillomavirus research (Amsterdam, Netherlands). 2017 ; Vol. 3. pp. 105-115.

Bibtex

@article{b3be385522c94d0c96f453a825269ec1,
title = "Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials",
abstract = "BACKGROUND: The immunogenicity profile of the 9-valent HPV (9vHPV) vaccine was evaluated across five phase III clinical studies conducted in girls and boys 9-15 years of age and young women 16-26 years of age. The effect of baseline characteristics of subjects on vaccine-induced HPV antibody responses was assessed.METHODS: Immunogenicity data from 11,304 subjects who received ≥1 dose of 9vHPV vaccine in five Phase III studies were analyzed. Vaccine was administered as a 3-dose regimen. HPV antibody titers were assessed 1 month after dose 3 using a competitive Luminex immunoassay and summarized as geometric mean titers (GMTs). Covariates examined were age, gender, race, region of residence, and HPV serostatus and PCR status at day 1.RESULTS: GMTs to all 9 vaccine HPV types decreased with age at vaccination initiation, and were otherwise generally similar among the demographic subgroups defined by gender, race and region of residence. For all subgroups defined by race or region of residence, GMTs were higher in girls and boys than in young women. Vaccination of subjects who were seropositive at day 1 to a vaccine HPV type resulted in higher GMTs to that type, compared with those in subjects who were seronegative for that type at day 1.CONCLUSIONS: 9vHPV vaccine immunogenicity was robust among subjects with differing baseline characteristics. It was generally comparable across subjects of different races and from different regions. Greater immunogenicity in girls and boys versus young women (the population used to establish 9vHPV vaccine efficacy in clinical studies) indicates that the anti-HPV responses generated by the vaccine in adolescents from all races or regions were sufficient to induce high-level protective efficacy. This immunogenicity profile supports a widespread 9vHPV vaccination program and early vaccination.",
keywords = "Journal Article",
author = "Petersen, {Lone K} and Jaime Restrepo and Moreira, {Edson D} and Ole-Erik Iversen and Punnee Pitisuttithum and {Van Damme}, Pierre and Joura, {Elmar A} and Sven-Erik Olsson and Daron Ferris and Stan Block and Giuliano, {Anna R} and Xavier Bosch and Sophie Pils and Jack Cuzick and Garland, {Suzanne M} and Warner Huh and Kjaer, {Susanne K} and Bautista, {Oliver M} and Donna Hyatt and Roger Maansson and Erin Moeller and Hong Qi and Christine Roberts and Alain Luxembourg",
note = "Copyright {\circledC} 2017 The Authors. Published by Elsevier B.V. All rights reserved.",
year = "2017",
month = "6",
doi = "10.1016/j.pvr.2017.03.002",
language = "English",
volume = "3",
pages = "105--115",
journal = "Papillomavirus Research",
issn = "2405-8521",
publisher = "Elsevier BV",

}

RIS

TY - JOUR

T1 - Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials

AU - Petersen, Lone K

AU - Restrepo, Jaime

AU - Moreira, Edson D

AU - Iversen, Ole-Erik

AU - Pitisuttithum, Punnee

AU - Van Damme, Pierre

AU - Joura, Elmar A

AU - Olsson, Sven-Erik

AU - Ferris, Daron

AU - Block, Stan

AU - Giuliano, Anna R

AU - Bosch, Xavier

AU - Pils, Sophie

AU - Cuzick, Jack

AU - Garland, Suzanne M

AU - Huh, Warner

AU - Kjaer, Susanne K

AU - Bautista, Oliver M

AU - Hyatt, Donna

AU - Maansson, Roger

AU - Moeller, Erin

AU - Qi, Hong

AU - Roberts, Christine

AU - Luxembourg, Alain

N1 - Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

PY - 2017/6

Y1 - 2017/6

N2 - BACKGROUND: The immunogenicity profile of the 9-valent HPV (9vHPV) vaccine was evaluated across five phase III clinical studies conducted in girls and boys 9-15 years of age and young women 16-26 years of age. The effect of baseline characteristics of subjects on vaccine-induced HPV antibody responses was assessed.METHODS: Immunogenicity data from 11,304 subjects who received ≥1 dose of 9vHPV vaccine in five Phase III studies were analyzed. Vaccine was administered as a 3-dose regimen. HPV antibody titers were assessed 1 month after dose 3 using a competitive Luminex immunoassay and summarized as geometric mean titers (GMTs). Covariates examined were age, gender, race, region of residence, and HPV serostatus and PCR status at day 1.RESULTS: GMTs to all 9 vaccine HPV types decreased with age at vaccination initiation, and were otherwise generally similar among the demographic subgroups defined by gender, race and region of residence. For all subgroups defined by race or region of residence, GMTs were higher in girls and boys than in young women. Vaccination of subjects who were seropositive at day 1 to a vaccine HPV type resulted in higher GMTs to that type, compared with those in subjects who were seronegative for that type at day 1.CONCLUSIONS: 9vHPV vaccine immunogenicity was robust among subjects with differing baseline characteristics. It was generally comparable across subjects of different races and from different regions. Greater immunogenicity in girls and boys versus young women (the population used to establish 9vHPV vaccine efficacy in clinical studies) indicates that the anti-HPV responses generated by the vaccine in adolescents from all races or regions were sufficient to induce high-level protective efficacy. This immunogenicity profile supports a widespread 9vHPV vaccination program and early vaccination.

AB - BACKGROUND: The immunogenicity profile of the 9-valent HPV (9vHPV) vaccine was evaluated across five phase III clinical studies conducted in girls and boys 9-15 years of age and young women 16-26 years of age. The effect of baseline characteristics of subjects on vaccine-induced HPV antibody responses was assessed.METHODS: Immunogenicity data from 11,304 subjects who received ≥1 dose of 9vHPV vaccine in five Phase III studies were analyzed. Vaccine was administered as a 3-dose regimen. HPV antibody titers were assessed 1 month after dose 3 using a competitive Luminex immunoassay and summarized as geometric mean titers (GMTs). Covariates examined were age, gender, race, region of residence, and HPV serostatus and PCR status at day 1.RESULTS: GMTs to all 9 vaccine HPV types decreased with age at vaccination initiation, and were otherwise generally similar among the demographic subgroups defined by gender, race and region of residence. For all subgroups defined by race or region of residence, GMTs were higher in girls and boys than in young women. Vaccination of subjects who were seropositive at day 1 to a vaccine HPV type resulted in higher GMTs to that type, compared with those in subjects who were seronegative for that type at day 1.CONCLUSIONS: 9vHPV vaccine immunogenicity was robust among subjects with differing baseline characteristics. It was generally comparable across subjects of different races and from different regions. Greater immunogenicity in girls and boys versus young women (the population used to establish 9vHPV vaccine efficacy in clinical studies) indicates that the anti-HPV responses generated by the vaccine in adolescents from all races or regions were sufficient to induce high-level protective efficacy. This immunogenicity profile supports a widespread 9vHPV vaccination program and early vaccination.

KW - Journal Article

U2 - 10.1016/j.pvr.2017.03.002

DO - 10.1016/j.pvr.2017.03.002

M3 - Journal article

VL - 3

SP - 105

EP - 115

JO - Papillomavirus Research

JF - Papillomavirus Research

SN - 2405-8521

ER -

ID: 52206710