Antibody Persistence and Booster Response of a Quadrivalent Meningococcal Conjugate Vaccine in Adolescents

• Published in: The Journal of pediatrics 2014-06, Vol.164 (6), p.1409-1415.e4
• Main Authors: Baxter, Roger, MD, Reisinger, Keith, MD, Block, Stanley L., MD, Izu, Allen, MS, Odrljin, Tatjana, MD, PhD, Dull, Peter, MD
• Format: Article
• Language: English
• Subjects: Adolescent; Antibodies, Bacterial - blood; Antibodies, Bacterial - immunology; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Humans; Immunization, Secondary - methods; Male; Meningitis, Meningococcal - immunology; Meningitis, Meningococcal - prevention & control; Meningococcal Infections - immunology; Meningococcal Infections - prevention & control; Meningococcal Vaccines - administration & dosage; Meningococcal Vaccines - adverse effects; Neisseria meningitidis - immunology; Patient Safety; Pediatrics; Risk Assessment; Time Factors; Treatment Outcome; Vaccination - methods; Vaccines, Conjugate - administration & dosage; Vaccines, Conjugate - adverse effects
• ISSN: 0022-3476; 1097-6833
• DOI: 10.1016/j.jpeds.2014.02.025

Objective To evaluate the tolerability and immunogenicity of a booster dose of the quadrivalent meningococcal conjugate vaccine MenACWY-CRM (Menveo, Novartis Vaccines and Diagnostics, Siena, Italy) administered 3 years after primary vaccination of adolescents enrolled in a phase 3 study with either MenACWY-CRM or MenACWY-D (Menactra, Sanofi Pasteur, Swiftwater, Pennsylvania). Study design A total of 730 healthy adolescents participated, including 622 initial study participants who received primary vaccination with MenACWY-CRM (n = 367) or MenACWY-D (n = 255) 3 years previously and 108 age-matched vaccine-naïve controls. A subset of MenACWY-CRM (n = 83) and MenACWY-D (n = 77) recipients were administered a MenACWY-CRM booster dose 3 years postprimary vaccination. Immunogenicity prior to and after the booster dose of MenACWY-CRM was measured by serum bactericidal assay with human complement (hSBA). Local and systemic reactions and adverse events were monitored in subjects receiving the booster dose. Results At 3 years postprimary vaccination, 64%, 82%, and 65% of subjects initially vaccinated with MenACWY-CRM (n = 367) showed hSBA titers ≥8 against serogroups C, W-135, and Y, respectively; this was lower for serogroup A (28%). Significantly more MenACWY-CRM recipients had hSBA titers ≥8 for serogroups W-135 and Y than MenACWY-D recipients (n = 255). A MenACWY-CRM booster dose resulted in 99%-100% of subjects demonstrating hSBA titers ≥8 against all serogroups, irrespective of primary vaccination (MenACWY-CRM, n = 83; MenACWY-D, n = 77). The booster dose was well tolerated without significant adverse events. Conclusions MenACWY-CRM can be used to boost adolescents who have received a primary vaccination with either MenACWY-CRM or MenACWY-D.