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

被引：32

作者：

Joura, Elmar A. ^{[1
]}

Ulied, Angels ^{[2
]}

Vandermeulen, Corinne ^{[3
]}

Rua Figueroa, Milagrosa ^{[4
]}

Seppa, Ilkka ^{[5
]}

Hernandez Aguado, Juan Jose ^{[6
]}

Ahonen, Anitta ^{[5
]}

Reich, Olaf ^{[7
]}

Virta, Miia ^{[5
]}

Perino, Antonino ^{[8
]}

Peris Tuser, Merce ^{[9
]}

Peters, Klaus ^{[10
]}

Origoni, Massimo ^{[11
,12
]}

Raspagliesi, Francesco ^{[13
]}

Tjalma, Wiebren A. A. ^{[14
,15
]}

Tummers, Philippe ^{[16
]}

Woelber, Linn ^{[17
]}

Nieminen, Pekka ^{[18
,19
]}

van Damme, Pierre ^{[20
]}

Sehouli, Jalid ^{[21
]}

Fiol Ruiz, Gabriel ^{[22
]}

Brucker, Sara ^{[23
]}

Fehm, Tanja ^{[24
,25
]}

Cheon, Kyeongmi ^{[26
]}

Rawat, Sonali ^{[26
]}

Luxembourg, Alain ^{[26
]}

Wittke, Frederick ^{[26
]}

机构：

[1] Med Univ Vienna, Comprehens Canc Ctr, Dept Gynecol & Obstet, Vienna, Austria

[2] EBA Centelles, Ctr Atencio Primaria, Barcelona, Spain

[3] Leuven Univ, Dept Publ Hlth & Primary Care, KU Leuven, Vaccinol Ctr, Ku Leuven, Belgium

[4] Hosp Univ Sanitas La Moraleja, Madrid, Spain

[5] Tampere Univ, Vaccine Res Ctr, Tampere, Finland

[6] Hosp Univ Infanta Leonor, Dept Obstet & Gynecol, Unit Lower Genital Tract Pathol, Madrid, Spain

[7] Med Univ Graz, Dept Obstet & Gynecol, Graz, Austria

[8] Univ Palermo, Villa Sofia Cervello Hosp, Gynecol & Obstet, Palermo, Italy

[9] Catalan Inst Oncol, Lhospitalet De Llobregat, Spain

[10] Praxis Gynecol Obstet & Clin Res, Berner Heerweg 157, Hamburg, Germany

[11] Univ Vita Salute San Raffaele, Dept Gynecol & Obstet, Sch Med, Milan, Italy

[12] IRCCS Osped San Raffaele, Milan, Italy

[13] Fdn IRCCS Natl Canc Inst, Dept Gynecol Oncol, Milan, Italy

[14] Antwerp Univ Hosp UZA, Dept Obstet & Gynaecol, Gynaecol Oncol Unit, Multidisciplinary Breast Clin, Antwerp, Belgium

[15] Univ Antwerp, Fac Med & Hlth Sci, Mol Imaging Pathol Radiotherapy & Oncol MIPRO, Antwerp, Belgium

[16] Ghent Univ Hosp UZ Ghent, Dept Obstet & Gynaecol, Gynaecol Oncol Unit, Ghent, Belgium

[17] Univ Med Ctr Hamburg Eppendorf, Dept Gynecol, Hamburg, Germany

[18] Helsinki Univ Hosp, Dept Obstet & Gynaecol, Helsinki, Finland

[19] Univ Helsinki, Helsinki, Finland

[20] Antwerp Univ, Ctr Evaluat Vaccinat, Vaccine & Infect Dis Inst, Antwerp, Belgium

[21] Charite, Competence Ctr Ovarian Canc EKZE, Dept Gynecol, D-13353 Berlin, Germany

[22] Torrecardenas Univ Hosp, Dept Obstet & Gynecol, Unit Gynecol Oncol & Lower Genital Tract, Almeria, Spain

[23] Eberhard Karls Univ Tuebingen, Univ Hosp Obstet & Gynecol, Dept Womens Hlth, Tubingen, Germany

[24] Heinrich Heine Univ Duesseldorf, Dept Obstet & Gynecol, Univ Hosp, D-40225 Dusseldorf, Germany

[25] Heinrich Heine Univ Duesseldorf, Med Fac, D-40225 Dusseldorf, Germany

[26] Merck & Co Inc, 2000 Galloping Hill Rd, Kenilworth, NJ 07033 USA

来源：

VACCINE | 2021年 / 39卷 / 20期

关键词：

Adult vaccination; Cervical cancer; HPV prophylaxis; Human papillomavirus; Nine-valent human papillomavirus vaccine; Precancer; 16/18 AS04-ADJUVANTED VACCINE; DOUBLE-BLIND; INTRAEPITHELIAL NEOPLASIA; CERVICAL LESIONS; POOLED ANALYSIS; GLOBAL BURDEN; YOUNG-WOMEN; HPV VACCINE; FOLLOW-UP; EFFICACY;

D O I：

10.1016/j.vaccine.2021.01.074

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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. (c) 2021 Elsevier Ltd. All rights reserved.

引用

页码：2800 / 2809

页数：10

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