Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial

BMC Infectious Diseases

Research Article

Ziad A. Memish¹  Devayani Kolhe²  Jacqueline M. Miller³  Marie Van der Wielen⁴  Dominique Boutriau⁴  Cecilia Montalban⁵  Charissa Fay Corazon Borja-Tabora⁶ 

[1] College of Medicine, Alfaisal University, Al Zahrawi Street, Al Maather, Al Takhassusi Rd, 11533, Riyadh, Saudi Arabia;GSK Pharmaceuticals Limited, Embassy Links, #5, SRT Road, 560052, Bangalore, India;GSK Vaccines, 2301 Renaissance Blvd, 19406, King of Prussia, PA, USA;GSK Vaccines, Avenue Fleming 20, B- 1300, Wavre, Belgium;Philippine General Hospital Manila, Taft Avenue, Ermita, 1000, Manila, Metro Manila, Philippines;Research Institute for Tropical Medicine, Corporate Ave, 1781, Muntinlupa City, Metro Manila, Philippines;

关键词: Quadrivalent meningococcal conjugate vaccine;    Bactericidal antibody;    Antibody persistence;    Safety;   

DOI  :  10.1186/s12879-015-1138-y

 received in 2015-02-12, accepted in 2015-09-21,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundLong-term protection against meningococcal disease is associated with persistence of post-vaccination antibodies at protective levels. We evaluated the bactericidal antibody persistence and safety of the quadrivalent meningococcal serogroups A, C, W and Y tetanus-toxoid conjugate vaccine (MenACWY-TT) and the meningococcal polysaccharide serogroups A, C, W, and Y vaccine (MenACWY-PS) up to 5 years post-vaccination.MethodsThis phase IIb, open, randomized, controlled study conducted in the Philippines and Saudi Arabia consisted of a vaccination phase and a long-term persistence phase. Healthy adolescents and adults aged 11–55 years were randomized (3:1) to receive a single dose of MenACWY-TT (ACWY-TT group) or MenACWY-PS (Men-PS group). Primary and persistence results up to 3 years post-vaccination have been previously reported. Antibody responses against meningococcal serogroups A, C, W, and Y were assessed by a serum bactericidal antibody assay using rabbit complement (rSBA, cut-off titers 1:8 and 1:128) at Year 4 and Year 5 post-vaccination. Vaccine-related serious adverse events (SAEs) and cases of meningococcal disease were assessed up to Year 5.ResultsOf the 500 vaccinated participants, 404 returned for the Year 5 study visit (Total Cohort Year 5). For the Total Cohort Year 5, 71.6–90.0 and 64.9–86.3 % of MenACWY-TT recipients had rSBA titers ≥1:8 and ≥1:128, respectively, compared to 24.8–74.3 and 21.0–68.6 % of MenACWY-PS recipients. The rSBA geometric mean titers (GMTs) remained above the pre-vaccination levels in both treatment groups. Exploratory analyses suggested that both rSBA GMTs as well as the percentages of participants with rSBA titers above the cut-offs were higher in the ACWY-TT than in the Men-PS group for serogroups A, W and Y, with no apparent difference for MenC. No SAEs related to vaccination or cases of meningococcal disease were reported up to Year 5.ConclusionThese results suggest that a single dose of MenACWY-TT could protect at least 72 % of vaccinated adolescents and adults against meningococcal disease at least 5 years post-vaccination.Trial registrationClinicalTrials.gov NCT00356369

【 授权许可】

CC BY   
© Borja-Tabora et al. 2015