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Safety and immunogenicity of a booster dose of meningococcal (groups A, C, W, and Y) polysaccharide diphtheria toxoid conjugate vaccine.
Vaccine. 2016 10 17; 34(44):5273-5278.V

Abstract

BACKGROUND

Quadrivalent meningococcal conjugate vaccines (MenACWY) were developed to offer long-term protection against invasive disease caused by serogroups A, C, W, and Y. Reduced MenACWY effectiveness within 5 years after primary vaccination (likely due to declining bactericidal antibody titers) has been described, particularly with respect to C and Y disease in the United States. We evaluated the safety and immunogenicity of a single booster dose of quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D) in adolescents and adults who received a previous dose 4-6 years earlier.

METHODS

This phase 2, open-label, multicenter study of 834 persons was conducted in the United States. Participants received a single 0.5-mL booster dose of MenACWY-D. Serogroup-specific bactericidal antibody geometric mean titers (GMTs) were measured with a serum bactericidal antibody assay using human complement (hSBA). Proportions of participants achieving antibody titers of ⩾1:8 for each vaccine serogroup on Days 6 and 28 were determined. Rates of adverse events (AEs), including serious adverse events (SAEs), were also assessed.

RESULTS

Before booster vaccination, 38.7-68.5% of participants had an hSBA titer ⩾1:8, depending on vaccine serogroup. By Day 6 post-vaccination, 98.2-99.1% of participants had hSBA titers ⩾1:8. By Day 28, >99% of participants achieved this threshold and the primary hypothesis (lower limit of the one-sided 95% confidence limit ⩾85% for each serogroup) was met. The GMT ratios (post-vaccination divided by pre-vaccination) at Day 28 ranged from 47.2 (serogroup A) to 209.1 (serogroup Y). Rates of AEs, including SAEs, were similar to those observed among adolescents and adults who received a primary dose of MenACWY-D in previous studies. There were no study discontinuations due to an AE and no deaths.

CONCLUSIONS

Booster vaccination with MenACWY-D was safe and induced robust bactericidal antibody responses, consistent with immune memory, among adolescents and adults 4-6 years after primary vaccination. ClinicalTrials.gov registration: NCT01442675.

Authors+Show Affiliations

Scientific and Medical Affairs Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, USA. Electronic address: corey.robertson@sanofipasteur.com.Scientific and Medical Affairs Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, USA; Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA. Electronic address: greenbed@pitt.edu.Kentucky Pediatric/Adult Research, 201 South 5th Street, Bardstown, KY 40004, USA. Electronic address: jhedrick@bardstowncable.net.Legacy Pediatrics, 1815 South Clinton Avenue, Suite 360, Rochester, NY 14618, USA. Electronic address: michael.pichichero@rochesterregional.org.Scientific and Medical Affairs Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, USA; Department of Health Policy, Vanderbilt University School of Medicine, Nashville, TN 37212, USA. Electronic address: michael.decker@vanderbilt.edu.Huguenot Pediatrics, 1407 Huguenot Road, Midlothian, VA 23113, USA. Electronic address: mks8400@comcast.net.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study

Language

eng

PubMed ID

27642132

Citation

Robertson, Corwin A., et al. "Safety and Immunogenicity of a Booster Dose of Meningococcal (groups A, C, W, and Y) Polysaccharide Diphtheria Toxoid Conjugate Vaccine." Vaccine, vol. 34, no. 44, 2016, pp. 5273-5278.
Robertson CA, Greenberg DP, Hedrick J, et al. Safety and immunogenicity of a booster dose of meningococcal (groups A, C, W, and Y) polysaccharide diphtheria toxoid conjugate vaccine. Vaccine. 2016;34(44):5273-5278.
Robertson, C. A., Greenberg, D. P., Hedrick, J., Pichichero, M., Decker, M. D., & Saunders, M. (2016). Safety and immunogenicity of a booster dose of meningococcal (groups A, C, W, and Y) polysaccharide diphtheria toxoid conjugate vaccine. Vaccine, 34(44), 5273-5278. https://doi.org/10.1016/j.vaccine.2016.09.003
Robertson CA, et al. Safety and Immunogenicity of a Booster Dose of Meningococcal (groups A, C, W, and Y) Polysaccharide Diphtheria Toxoid Conjugate Vaccine. Vaccine. 2016 10 17;34(44):5273-5278. PubMed PMID: 27642132.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of a booster dose of meningococcal (groups A, C, W, and Y) polysaccharide diphtheria toxoid conjugate vaccine. AU - Robertson,Corwin A, AU - Greenberg,David P, AU - Hedrick,James, AU - Pichichero,Michael, AU - Decker,Michael D, AU - Saunders,Martha, Y1 - 2016/09/15/ PY - 2016/04/29/received PY - 2016/08/04/revised PY - 2016/09/04/accepted PY - 2016/9/20/pubmed PY - 2017/12/12/medline PY - 2016/9/20/entrez KW - Adolescent KW - Adult KW - Booster KW - Conjugate KW - Immunization KW - Meningococcal vaccines KW - Vaccines SP - 5273 EP - 5278 JF - Vaccine JO - Vaccine VL - 34 IS - 44 N2 - BACKGROUND: Quadrivalent meningococcal conjugate vaccines (MenACWY) were developed to offer long-term protection against invasive disease caused by serogroups A, C, W, and Y. Reduced MenACWY effectiveness within 5 years after primary vaccination (likely due to declining bactericidal antibody titers) has been described, particularly with respect to C and Y disease in the United States. We evaluated the safety and immunogenicity of a single booster dose of quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D) in adolescents and adults who received a previous dose 4-6 years earlier. METHODS: This phase 2, open-label, multicenter study of 834 persons was conducted in the United States. Participants received a single 0.5-mL booster dose of MenACWY-D. Serogroup-specific bactericidal antibody geometric mean titers (GMTs) were measured with a serum bactericidal antibody assay using human complement (hSBA). Proportions of participants achieving antibody titers of ⩾1:8 for each vaccine serogroup on Days 6 and 28 were determined. Rates of adverse events (AEs), including serious adverse events (SAEs), were also assessed. RESULTS: Before booster vaccination, 38.7-68.5% of participants had an hSBA titer ⩾1:8, depending on vaccine serogroup. By Day 6 post-vaccination, 98.2-99.1% of participants had hSBA titers ⩾1:8. By Day 28, >99% of participants achieved this threshold and the primary hypothesis (lower limit of the one-sided 95% confidence limit ⩾85% for each serogroup) was met. The GMT ratios (post-vaccination divided by pre-vaccination) at Day 28 ranged from 47.2 (serogroup A) to 209.1 (serogroup Y). Rates of AEs, including SAEs, were similar to those observed among adolescents and adults who received a primary dose of MenACWY-D in previous studies. There were no study discontinuations due to an AE and no deaths. CONCLUSIONS: Booster vaccination with MenACWY-D was safe and induced robust bactericidal antibody responses, consistent with immune memory, among adolescents and adults 4-6 years after primary vaccination. ClinicalTrials.gov registration: NCT01442675. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/27642132/Safety_and_immunogenicity_of_a_booster_dose_of_meningococcal__groups_A_C_W_and_Y__polysaccharide_diphtheria_toxoid_conjugate_vaccine_ DB - PRIME DP - Unbound Medicine ER -