Open Access Research article

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

Charissa Borja-Tabora1, Cecilia Montalban2, Ziad A Memish3*, Marie Van der Wielen4, Veronique Bianco4, Dominique Boutriau4 and Jacqueline Miller5

Author affiliations

1 Research Institute for Tropical Medicine, Muntinlupa City, Philippines

2 Philippine General Hospital Manila, Manila, Philippines

3 College of Medicine, Alfaisal University, PO Box 54146, Riyadh, 11514, Saudi Arabia

4 GlaxoSmithKline Vaccines, Wavre, Belgium

5 GlaxoSmithKline Vaccines, King of Prussia, PA, USA

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Citation and License

BMC Infectious Diseases 2013, 13:116  doi:10.1186/1471-2334-13-116

Published: 5 March 2013

Abstract

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.

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