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DOI 10.1016/j.jpeds.2014.02.025

Медицинская библиотека · The Journal of pediatrics · 2014

Antibody persistence and booster response of a quadrivalent meningococcal conjugate vaccine in adolescents.

Baxter Roger, Reisinger Keith, Block Stanley L, Izu Allen, Odrljin Tatjana, Dull Peter

Клиническое исследование III фазыСравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

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.

Для цитирования: Baxter Roger, Reisinger Keith, Block Stanley L, Izu Allen, Odrljin Tatjana, Dull Peter. Antibody persistence and booster response of a quadrivalent meningococcal conjugate vaccine in adolescents.. The Journal of pediatrics. 2014. DOI: 10.1016/j.jpeds.2014.02.025.

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