One-year antibody persistence and safety of a 4-dose schedule of MenACWY-CRM in healthy infants from South Korea

다국어 초록 (Multilingual Abstract)

Purpose: Results from a post-marketing study to generate evidence on 1-year antibody persistence and safety following vaccination of infants from South Korea with the quadrivalent meningococcal conjugate vaccine MenACWY-CRM.
Materials and Methods: In this phase IV, open-label, multi-center study (NCT02446691), 128 infants received MenACWY-CRM at ages 2, 4, 6, and 12 months. One-year antibody persistence following the full vaccination course was evaluated (primary objective) for the four meningococcal serogroups (Men) by serum bactericidal activity assay using human or rabbit complement (hSBA/rSBA). Immune responses at 1-month post-vaccination and safety were also assessed.
Results: The percentage of children with hSBA titers ≥8 ranged between 94% (MenA) and 100% (MenY/W) 1-month post-vaccination, and from 39% (MenA) to 89% (MenY) 1-year post-vaccination. At least 99% and 92% of children had rSBA titers ≥8 and ≥128 against each meningococcal serogroup, 1-month post-vaccination. One-year post-vaccination, the percentage of children with rSBA titers ≥8 and ≥128 ranged from 54% (MenC) to 99% (MenA) and from 30% (MenC) to 98% (MenA). Geometric mean titers declined from 1-month to 1-year post-vaccination, when they varied between 6.8 (MenA) and 53.6 (MenW) by hSBA and between 17.2 (MenC) and 2,269.5 (MenA) by rSBA. At least one solicited and unsolicited adverse event was reported for 79% and 66% of children. Of 36 serious adverse events reported, none were vaccination-related.
Conclusion: Antibody persistence (hSBA/rSBA titers ≥8) was determined in 39%-99% of children 1 year after a 4-dose MenACWY-CRM series during infancy, with an acceptable clinical safety profile.

참고문헌 (Reference)

1 Clopper CJ, "The use of confidence or fiducial limits illustrated in the case of the binomial" 26 : 404-413, 1934

2 Pelton SI, "The global evolution of meningococcal epidemiology following the introduction of meningococcal vaccines" 59 (59): S3-S11, 2016

3 Olbrich KJ, "Systematic review of invasive meningococcal disease : sequelae and wuality of life impact on patients and their caregivers" 7 : 421-438, 2018

4 Maslanka SE, "Standardization and a multilaboratory comparison of Neisseria meningitidis serogroup A and C serum bactericidal assays. The Multilaboratory Study Group" 4 : 156-167, 1997

5 Lalwani S, "Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine(MenACWY-CRM)in healthy Indian subjects aged 2 to 75 years" 38 : 36-42, 2015

6 Klein NP, "Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants" 31 : 64-71, 2012

7 Lee H, "Prevalence and serogroup changes of Neisseria meningitidis in South Korea, 2010-2016" 8 : 5292-, 2018

8 Khatami A, "Persistence of the immune response at 5 years of age following infant immunisation with investigational quadrivalent MenACWY conjugate vaccine formulations" 30 : 2831-2838, 2012

9 Baxter R, "Persistence of the immune response after MenACWY-CRM vaccination and response to a booster dose, in adolescents, children and infants" 12 : 1300-1310, 2016

10 "Meningococcal vaccines: WHO position paper, November 2011" 86 : 521-539, 2011

11 World Health Organization, "Meningococcal meningitis: key facts" World Health Organization

12 World Health Organization, "Invasive meningococcal disease: serogroup distribution" World Health Organization

13 Dwilow R, "Invasive meningococcal disease in the 21st century : an update for the clinician" 15 : 2-, 2015

14 Snape MD, "Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants : a randomized controlled trial" 299 : 173-184, 2008

15 Huang LM, "Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2-18 years in Taiwan : results of an open label study" 32 : 5177-5184, 2014

16 Tregnaghi M, "Immunogenicity and safety of a quadrivalent meningococcal polysaccharide CRM conjugate vaccine in infants and toddlers" 26 : 22-30, 2014

17 Klein NP, "Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with measles, mumps, rubella, varicella vaccine in healthy toddlers" 30 : 3929-3936, 2012

18 Lee HJ, "Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine(MenACWY-CRM)in healthy Korean adolescents and adults" 28 : 204-210, 2014

19 Block SL, "Immunogenicity and safety of a 3- and 4-dose vaccination series of a meningococcal ACWY conjugate vaccine in infants: results of a phase 3b, randomized, open-label trial" 35 : e48-e59, 2016

20 "Highlights of prescribing information: Menveo" U.S. Food and Drug Administration

21 Korea Centers for Disease Control and Prevention, "Disease surveillance statistics. Public Health Weekly Report. Vol 12, No. 11" Korea Centers for Disease Control and Prevention

22 Johnston W, "Comparative assessment of a single dose and a 2-dose vaccination series of a quadrivalent meningococcal CRM-conjugate vaccine (MenACWY-CRM) in children 2-10 years of age" 35 : e19-e27, 2016

23 Jacobson RM, "Antibody persistence and response to a booster dose of a quadrivalent conjugate vaccine for meningococcal disease in adolescents" 32 : e170-e177, 2013

24 Baxter R, "Antibody persistence and booster response of a quadrivalent meningococcal conjugate vaccine in adolescents" 164 : 1409-1415, 2014

25 Baxter R, "Antibody persistence after primary and booster doses of a quadrivalent meningococcal conjugate vaccine in adolescents" 33 : 1169-1176, 2014

26 Block SL, "Antibody persistence 5 years after vaccination at 2 to 10 years of age with Quadrivalent MenACWY-CRM conjugate vaccine, and responses to a booster vaccination" 33 : 2175-2182, 2015

27 Keshavan P, "An update of clinical experience with the quadrivalent meningococcal ACWY-CRM conjugate vaccine" 17 : 865-880, 2018

28 Kim SA, "An expanded age range for meningococcal meningitis : molecular diagnostic evidence from population-based surveillance in Asia" 12 : 310-, 2012

29 Jamie Findlow, "A review of complement sources used in serum bactericidal assays for evaluating immune responses to meningococcal ACWY conjugate vaccines" Informa UK Limited 15 (15): 2491-2500, 2019

30 Klein NP, "1085: Persistence of meningococcal bactericidal antibodies and booster response at 60-months of age in children who received infant or toddler doses of MenACWY-CRM conjugate vaccine" 1 (1): S319-, 2014