Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants

被引：85

作者：

Greenberg, David ^{[1
]}

Hoover, Patricia A. ^{[2
]}

Vesikari, Timo ^{[3
]}

Peltier, Christopher ^{[4
]}

Hurley, David C. ^{[5
]}

McFetridge, Richard D. ^{[2
]}

Dallas, Michael ^{[2
]}

Hartzel, Jonathan ^{[2
]}

Marchese, Rocio D. ^{[2
]}

Coller, Beth-Ann G. ^{[2
]}

Stek, Jon E. ^{[2
]}

Abeygunawardana, Chitrananda ^{[2
]}

Winters, Michael A. ^{[2
]}

MacNair, John E. ^{[2
]}

Pujar, Narahari S. ^{[2
]}

Musey, Luwy ^{[2
]}

机构：

[1] Soroka Univ, Med Ctr, Beer Shiva, Israel

[2] Merck & Co Inc, 2000 Galloping Hill Rd,UG3CD-28, Kenilworth, NJ 07033 USA

[3] Univ Tampere, Tampere, Finland

[4] Pediat Associates Mt Carmel, Cincinnati, OH USA

[5] Cottonwood Pediat, Murray, UT USA

来源：

VACCINE | 2018年 / 36卷 / 45期

关键词：

Pneumococcal conjugate vaccine; Safety; Immunogenicity; STREPTOCOCCUS-PNEUMONIAE; HAEMOPHILUS-INFLUENZAE; CHILDREN; DISEASE; 7-VALENT; TODDLERS; ADULTS; EPIDEMIOLOGY; SURVEILLANCE; TOLERABILITY;

D O I：

10.1016/j.vaccine.2018.02.113

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: Pediatric use of pneumococcal conjugate vaccines (PCV) has been associated with significant decrease in disease burden. However, disease caused by non-vaccine serotypes has increased. Safety and immunogenicity of 15-valent PCV (PCV15) containing serotypes included in 13-valent PCV (PCV13) plus serotypes 22F and 33F were evaluated in infants (NCT01215188). Methods: Infants received adjuvanted PCV15, nonadjuvanted PCV15, or PCV13 at 2, 4, 6, and 12-15 months of age. Safety was monitored for 14 days after each dose. Serotype-specific IgG geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured at postdose-3, predose-4, and postdose-4. Results: Safety profiles were comparable across vaccination groups. At postdose-3, both PCV15 formulations were non-inferior to PCV13 for 10 of 13 shared serotypes but failed non-inferiority for 3 serotypes (6A, 6B, and 19A) based on proportion of subjects achieving IgG GMC >= 0.35 mu g/mL. Adjuvanted PCV15 and nonadjuvanted PCV15 were non-inferior to PCV13 for 11 and 8 shared serotypes, respectively, based on postdose 3 comparisons of GMC ratios. PCV15 induced higher antibodies to serotypes 3, 22F, and 33F than PCV13. Conclusions: PCV15 displayed acceptable safety profile and induced IgG and OPA to all 15 vaccine serotypes at levels comparable to PCV13 for 10 of 13 shared serotypes. Study identification: V114-003. (C) 2018 Elsevier Ltd. All rights reserved.

引用

页码：6883 / 6891

页数：9

共 35 条

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