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Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study

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Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study. / Joura, Elmar A; Ulied, Angels; Vandermeulen, Corinne; Rua Figueroa, Milagrosa; Seppä, Ilkka; Hernandez Aguado, Juan José; Ahonen, Anitta; Reich, Olaf; Virta, Miia; Perino, Antonino; Peris Tuser, Merce; Peters, Klaus; Origoni, Massimo; Raspagliesi, Francesco; Tjalma, Wiebren A A; Tummers, Philippe; Woelber, Linn; Nieminen, Pekka; van Damme, Pierre; Sehouli, Jalid; Fiol Ruiz, Gabriel; Brucker, Sara; Fehm, Tanja; Cheon, Kyeongmi; Rawat, Sonali; Luxembourg, Alain; Wittke, Frederick.

in: VACCINE, Jahrgang 39, Nr. 20, 12.05.2021, S. 2800-2809.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Joura, EA, Ulied, A, Vandermeulen, C, Rua Figueroa, M, Seppä, I, Hernandez Aguado, JJ, Ahonen, A, Reich, O, Virta, M, Perino, A, Peris Tuser, M, Peters, K, Origoni, M, Raspagliesi, F, Tjalma, WAA, Tummers, P, Woelber, L, Nieminen, P, van Damme, P, Sehouli, J, Fiol Ruiz, G, Brucker, S, Fehm, T, Cheon, K, Rawat, S, Luxembourg, A & Wittke, F 2021, 'Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study', VACCINE, Jg. 39, Nr. 20, S. 2800-2809. https://doi.org/10.1016/j.vaccine.2021.01.074

APA

Joura, E. A., Ulied, A., Vandermeulen, C., Rua Figueroa, M., Seppä, I., Hernandez Aguado, J. J., Ahonen, A., Reich, O., Virta, M., Perino, A., Peris Tuser, M., Peters, K., Origoni, M., Raspagliesi, F., Tjalma, W. A. A., Tummers, P., Woelber, L., Nieminen, P., van Damme, P., ... Wittke, F. (2021). Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study. VACCINE, 39(20), 2800-2809. https://doi.org/10.1016/j.vaccine.2021.01.074

Vancouver

Joura EA, Ulied A, Vandermeulen C, Rua Figueroa M, Seppä I, Hernandez Aguado JJ et al. Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study. VACCINE. 2021 Mai 12;39(20):2800-2809. https://doi.org/10.1016/j.vaccine.2021.01.074

Bibtex

@article{0579361254a74dfea0f6de496dea5cad,
title = "Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study",
abstract = "BACKGROUND: Efficacy of the nine-valent human papillomavirus (9vHPV; HPV types 6/11/16/18/31/33/45/52/58) vaccine was demonstrated in a phase 3 study in women 16-26 years of age. We present a phase 3 immunogenicity and safety study of the 9vHPV vaccine in women 27-45 versus 16-26 years of age.METHODS: This international, open-label study (NCT03158220) was conducted in women 16-45 years of age. Participants (16-26 years, n = 570 and 27-45 years, n = 642) received a three-dose 9vHPV vaccination regimen (day 1, month 2, month 6). Month 7 geometric mean titers (GMTs) and seroconversion percentages to anti-HPV 6/11/16/18/31/33/45/52/58 were assessed. Participants were followed for safety throughout the study.RESULTS: At month 7, anti-HPV 6/11/16/18/31/33/45/52/58 GMTs in women 27-45 years were compared to those in women 16-26 years of age. The primary hypothesis of non-inferiority of anti-HPV 16/18/31/33/45/52/58 GMTs in older versus younger women was met. The lower bound of the GMT ratio 95% confidence interval (27-45 years to 16-26 years) was 0.60-0.67 depending on HPV type, exceeding the non-inferiority margin of 0.5 for all HPV types. Month 7 seroconversion percentages in women 27-45 years of age were >99% for all HPV types. Injection-site and vaccine-related systemic adverse events (AEs) were observed in 87.5% and 25.1% of women 16-26 years, and 85.2% and 24.1% of women 27-45 years of age, respectively; no vaccine-related serious AEs were reported and no deaths occurred during the study.CONCLUSIONS: The 9vHPV vaccine elicited non-inferior anti-HPV GMTs in women 27-45 years compared with women 16-26 years of age for HPV 16/18/31/33/45/52/58. The vaccine was generally well tolerated with a similar AE profile across the age groups. These data support bridging 9vHPV vaccine efficacy findings in women 16-26 years to women 27-45 years of age. Clinical trial registration NCT03158220.",
keywords = "Adolescent, Adult, Aged, Antibodies, Viral, Female, Human papillomavirus 16, Human papillomavirus 18, Humans, Immunogenicity, Vaccine, Papillomavirus Infections/prevention & control, Papillomavirus Vaccines/adverse effects, Young Adult",
author = "Joura, {Elmar A} and Angels Ulied and Corinne Vandermeulen and {Rua Figueroa}, Milagrosa and Ilkka Sepp{\"a} and {Hernandez Aguado}, {Juan Jos{\'e}} and Anitta Ahonen and Olaf Reich and Miia Virta and Antonino Perino and {Peris Tuser}, Merce and Klaus Peters and Massimo Origoni and Francesco Raspagliesi and Tjalma, {Wiebren A A} and Philippe Tummers and Linn Woelber and Pekka Nieminen and {van Damme}, Pierre and Jalid Sehouli and {Fiol Ruiz}, Gabriel and Sara Brucker and Tanja Fehm and Kyeongmi Cheon and Sonali Rawat and Alain Luxembourg and Frederick Wittke",
note = "Copyright {\textcopyright} 2021 Elsevier Ltd. All rights reserved.",
year = "2021",
month = may,
day = "12",
doi = "10.1016/j.vaccine.2021.01.074",
language = "English",
volume = "39",
pages = "2800--2809",
journal = "VACCINE",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "20",

}

RIS

TY - JOUR

T1 - Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study

AU - Joura, Elmar A

AU - Ulied, Angels

AU - Vandermeulen, Corinne

AU - Rua Figueroa, Milagrosa

AU - Seppä, Ilkka

AU - Hernandez Aguado, Juan José

AU - Ahonen, Anitta

AU - Reich, Olaf

AU - Virta, Miia

AU - Perino, Antonino

AU - Peris Tuser, Merce

AU - Peters, Klaus

AU - Origoni, Massimo

AU - Raspagliesi, Francesco

AU - Tjalma, Wiebren A A

AU - Tummers, Philippe

AU - Woelber, Linn

AU - Nieminen, Pekka

AU - van Damme, Pierre

AU - Sehouli, Jalid

AU - Fiol Ruiz, Gabriel

AU - Brucker, Sara

AU - Fehm, Tanja

AU - Cheon, Kyeongmi

AU - Rawat, Sonali

AU - Luxembourg, Alain

AU - Wittke, Frederick

N1 - Copyright © 2021 Elsevier Ltd. All rights reserved.

PY - 2021/5/12

Y1 - 2021/5/12

N2 - BACKGROUND: Efficacy of the nine-valent human papillomavirus (9vHPV; HPV types 6/11/16/18/31/33/45/52/58) vaccine was demonstrated in a phase 3 study in women 16-26 years of age. We present a phase 3 immunogenicity and safety study of the 9vHPV vaccine in women 27-45 versus 16-26 years of age.METHODS: This international, open-label study (NCT03158220) was conducted in women 16-45 years of age. Participants (16-26 years, n = 570 and 27-45 years, n = 642) received a three-dose 9vHPV vaccination regimen (day 1, month 2, month 6). Month 7 geometric mean titers (GMTs) and seroconversion percentages to anti-HPV 6/11/16/18/31/33/45/52/58 were assessed. Participants were followed for safety throughout the study.RESULTS: At month 7, anti-HPV 6/11/16/18/31/33/45/52/58 GMTs in women 27-45 years were compared to those in women 16-26 years of age. The primary hypothesis of non-inferiority of anti-HPV 16/18/31/33/45/52/58 GMTs in older versus younger women was met. The lower bound of the GMT ratio 95% confidence interval (27-45 years to 16-26 years) was 0.60-0.67 depending on HPV type, exceeding the non-inferiority margin of 0.5 for all HPV types. Month 7 seroconversion percentages in women 27-45 years of age were >99% for all HPV types. Injection-site and vaccine-related systemic adverse events (AEs) were observed in 87.5% and 25.1% of women 16-26 years, and 85.2% and 24.1% of women 27-45 years of age, respectively; no vaccine-related serious AEs were reported and no deaths occurred during the study.CONCLUSIONS: The 9vHPV vaccine elicited non-inferior anti-HPV GMTs in women 27-45 years compared with women 16-26 years of age for HPV 16/18/31/33/45/52/58. The vaccine was generally well tolerated with a similar AE profile across the age groups. These data support bridging 9vHPV vaccine efficacy findings in women 16-26 years to women 27-45 years of age. Clinical trial registration NCT03158220.

AB - BACKGROUND: Efficacy of the nine-valent human papillomavirus (9vHPV; HPV types 6/11/16/18/31/33/45/52/58) vaccine was demonstrated in a phase 3 study in women 16-26 years of age. We present a phase 3 immunogenicity and safety study of the 9vHPV vaccine in women 27-45 versus 16-26 years of age.METHODS: This international, open-label study (NCT03158220) was conducted in women 16-45 years of age. Participants (16-26 years, n = 570 and 27-45 years, n = 642) received a three-dose 9vHPV vaccination regimen (day 1, month 2, month 6). Month 7 geometric mean titers (GMTs) and seroconversion percentages to anti-HPV 6/11/16/18/31/33/45/52/58 were assessed. Participants were followed for safety throughout the study.RESULTS: At month 7, anti-HPV 6/11/16/18/31/33/45/52/58 GMTs in women 27-45 years were compared to those in women 16-26 years of age. The primary hypothesis of non-inferiority of anti-HPV 16/18/31/33/45/52/58 GMTs in older versus younger women was met. The lower bound of the GMT ratio 95% confidence interval (27-45 years to 16-26 years) was 0.60-0.67 depending on HPV type, exceeding the non-inferiority margin of 0.5 for all HPV types. Month 7 seroconversion percentages in women 27-45 years of age were >99% for all HPV types. Injection-site and vaccine-related systemic adverse events (AEs) were observed in 87.5% and 25.1% of women 16-26 years, and 85.2% and 24.1% of women 27-45 years of age, respectively; no vaccine-related serious AEs were reported and no deaths occurred during the study.CONCLUSIONS: The 9vHPV vaccine elicited non-inferior anti-HPV GMTs in women 27-45 years compared with women 16-26 years of age for HPV 16/18/31/33/45/52/58. The vaccine was generally well tolerated with a similar AE profile across the age groups. These data support bridging 9vHPV vaccine efficacy findings in women 16-26 years to women 27-45 years of age. Clinical trial registration NCT03158220.

KW - Adolescent

KW - Adult

KW - Aged

KW - Antibodies, Viral

KW - Female

KW - Human papillomavirus 16

KW - Human papillomavirus 18

KW - Humans

KW - Immunogenicity, Vaccine

KW - Papillomavirus Infections/prevention & control

KW - Papillomavirus Vaccines/adverse effects

KW - Young Adult

U2 - 10.1016/j.vaccine.2021.01.074

DO - 10.1016/j.vaccine.2021.01.074

M3 - SCORING: Journal article

C2 - 33676783

VL - 39

SP - 2800

EP - 2809

JO - VACCINE

JF - VACCINE

SN - 0264-410X

IS - 20

ER -