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

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• 作者：Roger Baxter ; MD¹ ; ^{roger.baxter@kp.org" class="auth_mail} ; Keith Reisinger ; MD² ; Stanley L. Block ; MD³ ; Allen Izu ; MS⁴ ; Tatjana Odrljin ; MD ; PhD⁴ ; Peter Dull ; MD⁴
• 关键词：AE ; Adverse event ; GMT ; Geometric mean titer ; hSBA ; Serum bactericidal assay with human complement ; PP ; Per-protocol ; rSBA ; Serum bactericidal assay with rabbit complement
• 刊名：The Journal of Pediatrics
• 出版年：June 2014
• 年：2014
• 卷：164
• 期：6
• 页码：1409-1415.e4
• 全文大小：557 K

文摘

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.