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

Lone K. Petersen, Jaime Restrepo, Edson D. Moreira, Ole Erik Iversen, Punnee Pitisuttithum, Pierre Van Damme, Elmar A. Joura, Sven Erik Olsson, Daron Gale Ferris, Stan Block, Anna R. Giuliano, Xavier Bosch, Sophie Pils, Jack Cuzick, Suzanne M. Garland, Warner Huh, Susanne K. Kjaer, Oliver M. Bautista, Donna Hyatt, Roger MaanssonErin Moeller, Hong Qi, Christine Roberts, Alain Luxembourg

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)105-115
Number of pages11
JournalPapillomavirus Research
Volume3
DOIs
StatePublished - Jun 1 2017

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Papillomavirus Vaccines
Phase III Clinical Trials
Vaccination
Vaccines
Immunoassay
Antibody Formation
Demography
Polymerase Chain Reaction
Antibodies
Population

Keywords

  • 9v HPV vaccine
  • Clinical trial
  • Human papillomavirus
  • Immunogenicity

ASJC Scopus subject areas

  • Virology
  • Infectious Diseases

Cite this

Petersen, L. K., Restrepo, J., Moreira, E. D., Iversen, O. E., Pitisuttithum, P., Van Damme, P., ... 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, 3, 105-115. https://doi.org/10.1016/j.pvr.2017.03.002

Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine – A combined analysis of five phase III clinical trials. / Petersen, Lone K.; Restrepo, Jaime; Moreira, Edson D.; Iversen, Ole Erik; Pitisuttithum, Punnee; Van Damme, Pierre; Joura, Elmar A.; Olsson, Sven Erik; Ferris, Daron Gale; 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.

In: Papillomavirus Research, Vol. 3, 01.06.2017, p. 105-115.

Research output: Contribution to journalArticle

Petersen, LK, Restrepo, J, Moreira, ED, Iversen, OE, Pitisuttithum, P, Van Damme, P, Joura, EA, Olsson, SE, Ferris, DG, 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, vol. 3, pp. 105-115. https://doi.org/10.1016/j.pvr.2017.03.002
Petersen, Lone K. ; Restrepo, Jaime ; Moreira, Edson D. ; Iversen, Ole Erik ; Pitisuttithum, Punnee ; Van Damme, Pierre ; Joura, Elmar A. ; Olsson, Sven Erik ; Ferris, Daron Gale ; 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. 2017 ; Vol. 3. pp. 105-115.
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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.",
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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 Gale

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

PY - 2017/6/1

Y1 - 2017/6/1

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 - 9v HPV vaccine

KW - Clinical trial

KW - Human papillomavirus

KW - Immunogenicity

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