Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 vaccine and HPV-6/11/16/18 vaccine Follow-up from months 12-24 in a Phase III randomized study of healthy women aged 18-45 years

被引：129

作者：

Einstein, Mark H. ^{[1
]}

Baron, Mira ^{[2
]}

Levin, Myron J. ^{[3
,4
]}

Chatterjee, Archana ^{[5
]}

Fox, Bradley ^{[11
]}

Scholar, Sofia ^{[6
]}

Rosen, Jeffrey ^{[7
]}

Chakhtoura, Nahida ^{[8
]}

Meric, Dorothee ^{[9
]}

Dessy, Francis J. ^{[9
]}

Datta, Sanjoy K. ^{[9
]}

Descamps, Dominique ^{[9
]}

Dubin, Gary ^{[10
]}

机构：

[1] Montefiore Med Ctr, Albert Einstein Coll Med, Dept Obstet & Gynecol & Womens Hlth, Div Gynecol Oncol, Bronx, NY 10467 USA

[2] Rapid Med Res, Cleveland, OH USA

[3] Univ Colorado Denver, Aurora, CO USA

[4] Hlth Sci Ctr, Aurora, CO USA

[5] Creighton Univ, Sch Med, Omaha, NE USA

[6] Walla Walla Clin, Walla Walla, WA USA

[7] CliRes S Florida, Coral Gables, FL USA

[8] Univ Miami, Miami, FL USA

[9] GlaxoSmithKline Biol, Rixensart, Belgium

[10] GlaxoSmithKline Biol, New York, NY USA

[11] Liberty Family Practice, Erie, PA USA

来源：

HUMAN VACCINES | 2011年 / 7卷 / 12期

关键词：

Cervarix (R); Gardasil (R); human papillomavirus; immunogenicity; safety; CD4(+) T-CELLS; PARTICLE VACCINE; YOUNG-WOMEN; SUSTAINED EFFICACY; NATURAL-HISTORY; DOUBLE-BLIND; TYPE-16; INFECTION; IMMUNITY; EPITOPE;

D O I：

10.4161/hv.7.12.18281

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

In this observer-blind study (NCT00423046), women (N = 1,106), stratified by age (18-26, 27-35, 36-45 y), were randomized (1: 1) to receive the HPV-16/18 vaccine (Cervarix (R), GlaxoSmithKline Biologicals, Months 0, 1, 6) or the HPV-6/11/16/18 vaccine (Gardasil (R) Merck and Co., Inc., Months 0, 2, 6). Month 7 results were previously reported; we now report Month 24 results. In the according-to-protocol cohort for immunogenicity (seronegative and DNA-negative at baseline for HPV type analyzed), seropositivity rates of neutralizing antibodies (nAbs) [pseudovirion-based neutralization assay] were, across all age strata, 100% (HPV-16/18 vaccine) and 97.5-100% (HPV-6/11/16/18 vaccine) for HPV-16, and 99.0-100% (HPV-16/18 vaccine) and 72.3-84.4% (HPV-6/11/16/18 vaccine) for HPV-18. Corresponding geometric mean titers (GMTs) were 2.4-5.8-fold higher for HPV-16 and 7.7-9.4-fold higher for HPV-18 with the HPV-16/18 vaccine vs. the HPV-6/11/16/18 vaccine; HPV-16 and HPV-18 GMTs were significantly higher with the HPV-16/18 vaccine than the HPV-6/11/16/18 vaccine (p < 0.0001) in the total vaccinated cohort (received >= 1 vaccine dose, irrespective of baseline sero/DNA-status). Similar results were obtained using enzyme-linked immunosorbent assay (ELISA). Positivity rates and GMTs of antigen-specific IgG antibodies in cervicovaginal secretions (ELISA) were not significantly different between vaccines. At Month 24, CD4(+) T-cell responses for HPV-16 and HPV-18 were higher with the HPV-16/18 vaccine; memory B-cell response was higher for HPV-18 with the HPV-16/18 vaccine and similar between vaccines for HPV-16. Both vaccines were generally well tolerated. Although an immunological correlate of protection has not been defined, differences in the magnitude of immune response between vaccines may represent determinants of duration of protection.

引用

页码：1343 / 1358

页数：16

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