PMID- 27642132 OWN - NLM STAT- MEDLINE DCOM- 20171211 LR - 20201209 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 34 IP - 44 DP - 2016 Oct 17 TI - Safety and immunogenicity of a booster dose of meningococcal (groups A, C, W, and Y) polysaccharide diphtheria toxoid conjugate vaccine. PG - 5273-5278 LID - S0264-410X(16)30799-X [pii] LID - 10.1016/j.vaccine.2016.09.003 [doi] AB - 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. CI - Copyright (c) 2016 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Robertson, Corwin A AU - Robertson CA AD - Scientific and Medical Affairs Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, USA. Electronic address: corey.robertson@sanofipasteur.com. FAU - Greenberg, David P AU - Greenberg DP AD - 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. FAU - Hedrick, James AU - Hedrick J AD - Kentucky Pediatric/Adult Research, 201 South 5th Street, Bardstown, KY 40004, USA. Electronic address: jhedrick@bardstowncable.net. FAU - Pichichero, Michael AU - Pichichero M AD - Legacy Pediatrics, 1815 South Clinton Avenue, Suite 360, Rochester, NY 14618, USA. Electronic address: michael.pichichero@rochesterregional.org. FAU - Decker, Michael D AU - Decker MD AD - 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. FAU - Saunders, Martha AU - Saunders M AD - Huguenot Pediatrics, 1407 Huguenot Road, Midlothian, VA 23113, USA. Electronic address: mks8400@comcast.net. LA - eng SI - ClinicalTrials.gov/NCT01442675 PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study DEP - 20160915 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Bacterial) RN - 0 (Diphtheria Toxoid) RN - 0 (MenACWY-D vaccine) RN - 0 (Meningococcal Vaccines) RN - 0 (Polysaccharides, Bacterial) RN - 0 (Vaccines, Conjugate) SB - IM MH - Adolescent MH - Adult MH - Adverse Drug Reaction Reporting Systems MH - Antibodies, Bacterial/blood MH - Diphtheria Toxoid/*immunology MH - Female MH - Humans MH - *Immunization, Secondary MH - Immunologic Memory MH - Male MH - Meningococcal Infections/immunology/*prevention & control MH - Meningococcal Vaccines/administration & dosage/*adverse effects/*immunology MH - Middle Aged MH - Neisseria meningitidis/classification/immunology MH - Polysaccharides, Bacterial/*immunology MH - Serogroup MH - Serum Bactericidal Antibody Assay MH - Time Factors MH - United States MH - Vaccines, Conjugate/adverse effects/immunology MH - Young Adult OTO - NOTNLM OT - Adolescent OT - Adult OT - Booster OT - Conjugate OT - Immunization OT - Meningococcal vaccines OT - Vaccines EDAT- 2016/09/20 06:00 MHDA- 2017/12/12 06:00 CRDT- 2016/09/20 06:00 PHST- 2016/04/29 00:00 [received] PHST- 2016/08/04 00:00 [revised] PHST- 2016/09/04 00:00 [accepted] PHST- 2016/09/20 06:00 [pubmed] PHST- 2017/12/12 06:00 [medline] PHST- 2016/09/20 06:00 [entrez] AID - S0264-410X(16)30799-X [pii] AID - 10.1016/j.vaccine.2016.09.003 [doi] PST - ppublish SO - Vaccine. 2016 Oct 17;34(44):5273-5278. doi: 10.1016/j.vaccine.2016.09.003. Epub 2016 Sep 15.