The investigational meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (ACWY-TT) and the seasonal influenza virus vaccine are immunogenic and well-tolerated when co-administered in adults

Abstract

Co-administration of meningococcal serogroups A, C, W-135 and Y conjugate vaccine (ACWY-TT) with seasonal influenza vaccine was investigated in a subset of adults enrolled in a larger study evaluating lot-to-lot consistency of ACWY-TT and non-inferiority to licensed tetravalent meningococcal polysaccharide vaccine (MenPS). Subjects in this sub-study were randomized (3:1:1) to receive ACWY-TT alone (ACWY-TT group) or with seasonal influenza vaccine (Coad), or licensed MenPS alone. Serum bactericidal antibodies (rSBA) and serum haemagglutination-inhibition (HI) antibody titers were measured pre- and 1 mo post-vaccination. Non-inferiority of the Coad group compared with ACWY-TT group was demonstrated in terms of rSBA geometric mean antibody titers (GMTs) to serogroups A, W-135 and Y. For serogroup C the pre-defined non-inferiority limit was marginally exceeded. Post-vaccination rSBA GMTs were significantly higher (exploratory analysis) in the Coad group compared with the MenPS group for serogroups A, W-135, and Y and were similar to the MenPS group for serogroup C. Overall, > 97% of subjects achieved rSBA titers ≥ 1:128 for all serogroups. The Coad group met all criteria defined by the Committee on Human Medicinal Products (CHMP) for seroprotection, seroconversion and seroconversion factor for HI antibodies for all three influenza strains. Grade 3 solicited local/general symptoms were reported by ≤ 1.9% of subjects in any group. These data support the co-administration of ACWY-TT with seasonal influenza vaccine when protection is needed against both diseases.

 

This study is registered at clinicaltrials.gov NCT00453986

Keywords: :

• ACWY vaccine
• Neisseria meningitidis
• adult
• co-administration
• immunogenicity
• influenza vaccine
• polysaccharide vaccine
• vaccine

Sources of Support

GlaxoSmithKline Biologicals was the funding source and was involved in all stages of the study conduct and analysis. GSK Biologicals also funded all costs associated with the development and the publishing of the present manuscript. The corresponding author had full access to the data.

Disclosure of Potential Conflicts of Interest

MRADLR, GD and ED have received consulting fees and honoraria from GSK within the past three years. NM declares no conflict of interest. VB, YB and JM are employees of GSK Biologicals. YB and JM report ownership of GSK Biologicals stocks and stock options.

Acknowledgments

The authors thank the individuals who participated in the study, and all investigators involved in conducting the study. The authors also thank Sally Gatchalian, Sameh Anis, Aline Stukkens and Jane Nappa for their assistance in coordination of the study; Dr. Fotios Vikas (GSK) for assistance in preparation of study reports; Laurence Fissette (GSK) for performing the statistical analysis and Dr. Brigitte Cheuvart (GSK) for statistical input in the protocol and study set-up; Dr. Dominique Boutriau and Dr. Peter Vink for input into protocol development; Dr. Pascal Lestrate and Koen Maleux for conducting the laboratory assays; Dr. Joanne Wolter (on behalf of GSK) for preparation of the first draft of the manuscript and Virginie Durbecq and Juliette Gray (Xpe Pharma and Science) for coordination and editorial assistance.