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

Jacqueline Miller³  Dominique Boutriau⁵  Veronique Bianco⁵  Marie Van der Wielen⁵  Ziad A Memish¹  Cecilia Montalban⁴  Charissa Borja-Tabora² 

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

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

Others  :  1171007
DOI  :  10.1186/1471-2334-13-116

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

【 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.

Trial registration

This study is registered at http://www.clinicaltrials.gov/NCT00356369 webcite.

【 授权许可】

   
2013 Borja-Tabora et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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