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

BMC Infectious Diseases

Research Article

Ziad A Memish¹  Jacqueline Miller²  Veronique Bianco³  Marie Van der Wielen³  Dominique Boutriau³  Cecilia Montalban⁴  Charissa Borja-Tabora⁵ 

[1] College of Medicine, Alfaisal University, PO Box 54146, 11514, Riyadh, Saudi Arabia;GlaxoSmithKline Vaccines, King of Prussia, PA, USA;GlaxoSmithKline Vaccines, Wavre, Belgium;Philippine General Hospital Manila, Manila, Philippines;Research Institute for Tropical Medicine, Muntinlupa City, Philippines;

关键词: Quadrivalent meningococcal vaccine;    Conjugate vaccine;    Bactericidal activity;    Persistence;    Safety;    The Philippines;    Saudi Arabia;   

DOI  :  10.1186/1471-2334-13-116

 received in 2012-05-23, accepted in 2013-02-26,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsIn 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.ResultsPre-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.ConclusionsThese results suggest that MenACWY-TT could protect adolescents and adults against meningococcal disease up to three years post-vaccination.Trial registrationThis study is registered at http://www.clinicaltrials.gov/NCT00356369.

【 授权许可】

Unknown   
© Borja-Tabora et al; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.