Oct 10, 2014 - Roger Baxter, MD1; Yaela Baine, PhD2; Devayani Kolhe, MSc3; Carmen Baccarini,. MD2; Jacqueline M Miller, MD, FAAP2; Marie Van Der ...
1086. 5-year Antibody Persistence and Booster Response to a Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Adolescents and Young Adults Roger Baxter, MD1; Yaela Baine, PhD2; Devayani Kolhe, MSc3; Carmen Baccarini, MD2; Jacqueline M Miller, MD, FAAP2; Marie Van Der Wielen, MD4; 1Kaiser Permanente Vaccine Study Center, Oakland, CA; 2GlaxoSmithKline Vaccines, King of Prussia, PA; 3GlaxoSmithKline Pharmaceuticals India Ltd., Bangalore, India; 4 GlaxoSmithKline Vaccines, Wavre, Belgium Session: 127. Vaccines: Meningococcal Friday, October 10, 2014: 12:30 PM Background. We evaluated antibody persistence 5 years after a single dose of Neisseria meningitidis serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) or MenACWY diphtheria toxoid conjugate vaccine (MenACWY‐ DT) in healthy adolescents and young adults, and subsequent MenACWY-TT booster vaccination in both groups compared to MenACWY-TT primary vaccination in newly enrolled, age-matched subjects. Methods. In this phase II, open, controlled, multicenter study in the United States (NCT00715910), subjects aged 15– < 31 years received a MenACWY-TT booster dose 5 years after MenACWY-TT (N = 183) or MenACWY-DT (N = 38) vaccination in study NCT00454909; naïve subjects aged 15– < 31 years (N = 101) received 1 MenACWY-TT dose. Immunogenicity was assessed pre- and 1 month post-vaccination by serum bactericidal antibody assay using human complement (hSBA; primary endpoint: 1:8 cut-off ). Solicited and unsolicited adverse events (AEs) were recorded for 4 and 31 days post-vaccination, respectively; subjects were followed up for serious AEs (SAEs) and the new onset of chronic diseases (NOCDs) for 6 months postvaccination. Results. Five years after 1 dose of MenACWY-TT or MenACWY-DT, ≥78.6% of subjects had hSBA titers ≥1:8 for MenC, MenW-135 and MenY, and ≥37.9% for MenA (Table). One month post-vaccination, ≥99.1% of previously primed and ≥92.5% (except MenA: 77.2%) of previously naïve subjects had hSBA titers ≥1:8 for each serogroup (Table). Geometric mean titers were higher in previously primed vs naïve subjects, and similar in MenACWY-TT-primed or MenACWY-DT-primed subjects (exploratory analyses). The most commonly reported solicited local and general AEs were pain (≤58.8% of subjects) and headache (≤35.9% of subjects) after booster vaccination compared to pain (60.4%) and fatigue (33.0%) after primary vaccination. No grade 3 vaccine-related unsolicited AEs, and no vaccine-related SAEs or NOCDs were reported.
Conclusion. Antibody persistence for serogroups C, W-135 and Y was observed in most subjects up to 5 years after 1 dose of MenACWY-TT or MenACWY-DT. A MenACWY-TT booster dose at year 5 elicited robust anamnestic responses, irrespective of the meningococcal vaccine used for priming, and was well-tolerated in 15– < 31 year-olds. Disclosures. R. Baxter, GSK: Grant Investigator, Research grant; Novartis: Grant Investigator, Research grant; Sanofi Pasteur: Grant Investigator, Research grant; Merck: Grant Investigator, Research grant Y. Baine, GlaxoSmithKline: Employee, Own stock and Salary D. Kolhe, GlaxoSmithKline: Employee, Salary C. Baccarini, GSK: Employee, Salary and Stock ownership J. M. Miller, GSK: Employee, Restricted Stock Grants and Salary M. Van Der Wielen, GSK Vaccines: Employee, Salary and Shares
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OFID 2014:1 (Suppl 1)
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Poster Abstracts
