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Antibody persistence and booster response of a quadrivalent meningococcal conjugate vaccine in adolescents.
J Pediatr. 2014 Jun; 164(6):1409-15.e4.JPed

Abstract

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.

Authors+Show Affiliations

Kaiser Permanente Vaccine Study Center, Oakland, CA. Electronic address: roger.baxter@kp.org.Primary Physicians Research, Pittsburgh, PA.Kentucky Pediatric and Adult Research, Bardstown, KY.Novartis Vaccines and Diagnostics, Inc, Cambridge, MA.Novartis Vaccines and Diagnostics, Inc, Cambridge, MA.Novartis Vaccines and Diagnostics, Inc, Cambridge, MA.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24657122

Citation

Baxter, Roger, et al. "Antibody Persistence and Booster Response of a Quadrivalent Meningococcal Conjugate Vaccine in Adolescents." The Journal of Pediatrics, vol. 164, no. 6, 2014, pp. 1409-15.e4.
Baxter R, Reisinger K, Block SL, et al. Antibody persistence and booster response of a quadrivalent meningococcal conjugate vaccine in adolescents. J Pediatr. 2014;164(6):1409-15.e4.
Baxter, R., Reisinger, K., Block, S. L., Izu, A., Odrljin, T., & Dull, P. (2014). Antibody persistence and booster response of a quadrivalent meningococcal conjugate vaccine in adolescents. The Journal of Pediatrics, 164(6), 1409-e4. https://doi.org/10.1016/j.jpeds.2014.02.025
Baxter R, et al. Antibody Persistence and Booster Response of a Quadrivalent Meningococcal Conjugate Vaccine in Adolescents. J Pediatr. 2014;164(6):1409-15.e4. PubMed PMID: 24657122.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antibody persistence and booster response of a quadrivalent meningococcal conjugate vaccine in adolescents. AU - Baxter,Roger, AU - Reisinger,Keith, AU - Block,Stanley L, AU - Izu,Allen, AU - Odrljin,Tatjana, AU - Dull,Peter, Y1 - 2014/03/20/ PY - 2012/06/14/received PY - 2013/12/16/revised PY - 2014/02/11/accepted PY - 2014/3/25/entrez PY - 2014/3/25/pubmed PY - 2014/8/19/medline SP - 1409 EP - 15.e4 JF - The Journal of pediatrics JO - J Pediatr VL - 164 IS - 6 N2 - 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. SN - 1097-6833 UR - https://www.unboundmedicine.com/medline/citation/24657122/Antibody_persistence_and_booster_response_of_a_quadrivalent_meningococcal_conjugate_vaccine_in_adolescents_ DB - PRIME DP - Unbound Medicine ER -