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

Mari Rose Aplasca-De Los Reyes, Efren Dimaano, Noel Macalalad, Ghassan Dbaibo, Veronique Bianco, Yaela Baine, Jacqueline Miller, Mari Rose Aplasca-De Los Reyes, Efren Dimaano, Noel Macalalad, Ghassan Dbaibo, Veronique Bianco, Yaela Baine, Jacqueline Miller

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.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3495724/bin/hvi-8-881-g1.jpg
Figure 1. rSBA GMTs in each group one month after vaccination (ATP Influenza cohort for immunogenicity). *statistically significant difference between the indicated group and the Coad group: differences between groups were done on GMT values adjusted for pre-vaccination measurements and age strata, exploratory analysis, whereas the GMTs displayed are unadjusted.
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3495724/bin/hvi-8-881-g2.jpg
Figure 2. Reverse cumulative curves showing rSBA titers for N. meningitidis serogroups A, C, W-135 and Y. ACWY+F, Coad group; ACWY_F, ACWY-TT group; MenPS_F, MenPS group
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3495724/bin/hvi-8-881-g3.jpg
Figure 3. Percentage of subjects reporting solicited local and general symptoms during the 4-day post-vaccination period (total vaccinated Influenza cohort). Note: For the Co-ad group, local symptoms refer to the percentage of subjects with at least one local symptom at either injection site. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Grade 3: Redness and swelling > 50mm, fever > 39.5°C, Preventing normal everyday activity for all other symptoms.

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Source: PubMed

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