PMID- 31495595 OWN - NLM STAT- MEDLINE DCOM- 20200907 LR - 20200907 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 37 IP - 42 DP - 2019 Sep 30 TI - MenACWY-CRM conjugate vaccine booster dose given 4-6 years after priming: Results from a phase IIIb, multicenter, open label study in adolescents and adults. PG - 6171-6179 LID - S0264-410X(19)31141-7 [pii] LID - 10.1016/j.vaccine.2019.08.065 [doi] AB - BACKGROUND: Vaccination strategies against bacterial meningitis vary across countries. In the United States, a single dose of quadrivalent meningococcal conjugate vaccine (MenACWY) is recommended at 11-12 years of age, with a booster dose approximately 5 years later. We assessed immune responses to a booster dose of MenACWY-CRM vaccine after priming with MenACWY-CRM or MenACWY-D vaccines in adolescents and adults. METHODS: In this phase IIIb, multicenter, open-label study, healthy 15-55-year-olds, who received MenACWY-CRM (N = 301) or MenACWY-D (N = 300) 4-6 years earlier or were meningococcal vaccine-naive (N = 100), received one MenACWY-CRM vaccine dose. Immunogenicity was evaluated pre-vaccination, 3 or 5 days post-vaccination (sampling subgroups), and 28 days post-vaccination by serum bactericidal activity assay using human complement (hSBA). After vaccination, participants were monitored for 7 days for reactogenicity, 29 days for unsolicited adverse events (AEs), and 181 days for serious AEs and medically-attended AEs. RESULTS: Sufficiency of the immune response to a MenACWY-CRM booster dose was demonstrated; the lower limit of the 1-sided 97.5% confidence interval for percentages of participants with hSBA seroresponse at 28 days post-vaccination was >75% for each serogroup in those primed with either the MenACWY-CRM or MenACWY-D vaccine. Seroresponse was observed in >/=93.24% of primed participants and >/=35.87% of naive participants 28 days post-vaccination. At 5 days post-booster, among primed participants, hSBA titers >/=1:8 were achieved in >/=47.14% of participants for MenA and in >/=85.52% of participants for MenC, MenW and MenY, and 3.25- to 8.59-fold increases in hSBA geometric mean titers against each vaccine serogroup were observed. No safety concerns were raised throughout the 6-month follow-up period. CONCLUSIONS: A booster dose of the MenACWY-CRM vaccine induced a robust and rapid anamnestic response in adolescents and adults, irrespectively of either MenACWY-CRM or MenACWY-D vaccine administered 4-6 years earlier, with an acceptable clinical safety profile. ClinicalTrials.gov registration: NCT02986854. CI - Copyright (c) 2019 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.. All rights reserved. FAU - Tipton, Mary AU - Tipton M AD - CopperView Medical Center, South Jordan, UT, United States. Electronic address: tipton@rx-research.com. FAU - Daly, Wendy AU - Daly W AD - Brownsboro Park Pediatrics, Louisville, KY, United States. FAU - Senders, Shelly AU - Senders S AD - Senders Pediatrics, Cleveland, OH, United States. Electronic address: ssenders@senderspediatrics.com. FAU - Block, Stanley L AU - Block SL AD - Kentucky Pediatric/Adult Research, Bardstown, KY, United States. FAU - Lattanzi, Maria AU - Lattanzi M AD - GSK, Siena, Italy. Electronic address: maria.x.lattanzi@gsk.com. FAU - Mzolo, Thembile AU - Mzolo T AD - GSK, Amsterdam, the Netherlands. Electronic address: thembile.x.mzolo@gsk.com. FAU - Barbi, Silvia AU - Barbi S AD - GSK, Amsterdam, the Netherlands. Electronic address: silvia.x.barbi@gsk.com. FAU - Pellegrini, Michele AU - Pellegrini M AD - GSK, Siena, Italy. Electronic address: michele.x.pellegrini@gsk.com. FAU - Keshavan, Pavitra AU - Keshavan P AD - GSK, Siena, Italy. Electronic address: pavitra.x.keshavan@gsk.com. LA - eng SI - ClinicalTrials.gov/NCT02986854 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20190905 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Bacterial) RN - 0 (MenACWY-CRM vaccine) RN - 0 (MenACWY-D vaccine) RN - 0 (Meningococcal Vaccines) RN - 9007-36-7 (Complement System Proteins) SB - IM MH - Adolescent MH - Adult MH - Antibodies, Bacterial/blood MH - Complement System Proteins/immunology MH - Female MH - Humans MH - Immunization, Secondary MH - Immunogenicity, Vaccine/*immunology MH - Immunologic Memory/immunology MH - Male MH - Meningitis, Meningococcal/immunology/*prevention & control MH - Meningococcal Vaccines/*immunology MH - Middle Aged MH - Neisseria meningitidis/*immunology MH - Vaccination MH - Young Adult OTO - NOTNLM OT - Adolescents OT - Adults OT - Booster response OT - Early immune response OT - Quadrivalent meningococcal conjugate vaccine OT - Safety EDAT- 2019/09/10 06:00 MHDA- 2020/09/08 06:00 CRDT- 2019/09/10 06:00 PHST- 2019/01/31 00:00 [received] PHST- 2019/08/25 00:00 [revised] PHST- 2019/08/26 00:00 [accepted] PHST- 2019/09/10 06:00 [pubmed] PHST- 2020/09/08 06:00 [medline] PHST- 2019/09/10 06:00 [entrez] AID - S0264-410X(19)31141-7 [pii] AID - 10.1016/j.vaccine.2019.08.065 [doi] PST - ppublish SO - Vaccine. 2019 Sep 30;37(42):6171-6179. doi: 10.1016/j.vaccine.2019.08.065. Epub 2019 Sep 5.