Immune response, antibody persistence, and safety of a single dose of the quadrivalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine in adolescents and adults: results of an open, randomised, controlled study

被引：40

作者：

Borja-Tabora, Charissa ^{[1
]}

Montalban, Cecilia ^{[2
]}

Memish, Ziad A. ^{[3
]}

Van der Wielen, Marie ^{[4
]}

Bianco, Veronique ^{[4
]}

Boutriau, Dominique ^{[4
]}

Miller, Jacqueline ^{[5
]}

机构：

[1] Res Inst Trop Med, Muntinlupa, Philippines

[2] Philippine Gen Hosp Manila, Manila, Philippines

[3] Alfaisal Univ, Coll Med, Riyadh 11514, Saudi Arabia

[4] GlaxoSmithKline Vaccines, Wavre, Belgium

[5] GlaxoSmithKline Vaccines, King Of Prussia, PA USA

来源：

BMC INFECTIOUS DISEASES | 2013年 / 13卷

关键词：

Quadrivalent meningococcal vaccine; Conjugate vaccine; Bactericidal activity; Persistence; Safety; The Philippines; Saudi Arabia; NEISSERIA-MENINGITIDIS SEROGROUP; POLYSACCHARIDE VACCINE; HERD-IMMUNITY; DISEASE; IMMUNOGENICITY; PROTECTION; HAJJ; CARRIAGE; OUTBREAK; IMPACT;

D O I：

10.1186/1471-2334-13-116

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Background: The best strategy to protect individuals against meningococcal disease is to immunize against multiple serogroups. Immunogenicity, antibody persistence, and safety of the EU-licensed meningococcal ACWY-tetanus toxoid conjugate vaccine (MenACWY-TT) were evaluated in healthy participants aged 11-55 years from the Philippines and Saudi Arabia. Methods: In this phase IIb, open, controlled study, 500 participants were randomised (3:1) to receive one dose of MenACWY-TT or a licensed meningococcal polysaccharide vaccine (Men-PS). Functional antibody responses against meningococcal serogroups A, C, W-135, and Y were assessed by a serum bactericidal antibody assay using rabbit complement (rSBA) at Month 0, Month 1, Year 1, Year 2, and Year 3. Vaccine response was defined as an rSBA titre >= 32 at Month 1 in participants who were seronegative (rSBA titre <8) pre-vaccination and as at least a four-fold increase in titre in participants who were seropositive pre-vaccination. Solicited symptoms were recorded up to Day 4, safety outcomes up to Month 6, and serious adverse events related to vaccination up to Year 3. Results: Pre-specified criteria for non-inferiority of MenACWY-TT versus Men-PS were met in terms of rSBA vaccine response and incidence of grade 3 general symptoms. At Month 1, 82.7%-96.3% of MenACWY-TT and 69.7%-91.7% in Men-PS recipients had a vaccine response for each serogroup. At Year 3, >= 99.1% and >= 92.9% of MenACWY-TT recipients retained rSBA titres >= 8 and >= 128, respectively, as compared to >= 86.7% and >= 80.0% in the Men-PS group. Both vaccines had a clinically acceptable safety profile, although injection site redness and swelling were more frequent in MenACWY-TT recipients. Conclusions: These results suggest that MenACWY-TT could protect adolescents and adults against meningococcal disease up to three years post-vaccination.

引用

页数：13