Antibody persistence and immune memory 15 months after priming with an investigational tetravalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) in toddlers and young children.

Zentrum für Kinder-und Jugendmedizin
Human vaccines & immunotherapeutics 07/2012; 8(7):866-72. DOI: 10.4161/hv.20229
Source: PubMed

ABSTRACT The present extension study, conducted in children originally vaccinated at 12-14 mo or 3-5 y of age, assessed antibody persistence and immune memory induced by an investigational tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT). In the original study, participants were randomized to receive one dose of MenACWY-TT or licensed age-appropriate meningococcal control vaccines. Fifteen months post-vaccination, all participants underwent serum sampling to evaluate antibody persistence and participants previously vaccinated as toddlers received a polysaccharide challenge to assess immune memory development. Exploratory comparisons showed that (1) All children and ≥ 92.3% of the toddlers maintained serum bactericidal (rSBA) titers ≥ 1:8 at 15 mo post MenACWY-TT vaccination; statistically significantly higher rSBA geometric mean titers (GMTs) were observed compared with control vaccines. (2) At one month after polysaccharide challenge, all toddlers primed with MenACWY-TT or with the monovalent serogroup C conjugate vaccine had rSBA titers ≥ 1:8 and ≥ 1:128 for serogroup C and similar rSBA-GMTs; rSBA-GMTs for serogroups A, W-135 and Y were statistically significantly higher in toddlers primed with MenACWY-TT compared with the control vaccine. Thus, a single dose of MenACWY-TT induced persisting antibodies in toddlers and children and immune memory in toddlers. This study has been registered at NCT00126984.

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    ABSTRACT: Long term protection against invasive meningococcal disease relies on persistence of bactericidal antibodies. We studied the persistence of serum bactericidal antibodies using rabbit and human complement (rSBA, hSBA assays) two years after vaccination with a meningococcal serogroup A, C, W, Y tetanus toxoid conjugate vaccine (MenACWY-TT, N = 253) or a licensed monovalent serogroup C conjugate vaccine (MenC-CRM197, N = 42) in Finnish toddlers who were aged 12–23 months at the time of vaccination. In 97.8–98.9% of subjects receiving MenACWY-TT, rSBA titres ⩾1:8 persisted against serogroups A, W and Y and 88.2% against serogroup C, which was according to exploratory analysis statistically significantly higher than in recipients of the MenC-CRM197 vaccine (69.0%). A total of 86.9% of subjects had persisting hSBA ⩾1:8 for serogroup C, which was statistically significantly higher than the MenC-CRM group (52.6%). Exploratory analysis also showed that the year 2 hSBA-MenC geometric mean titre was statistically significantly higher in the MenACWY-TT group than the MenC-CRM group. At least 87.0% of subjects had hSBA ⩾1:8 for serogroups W and Y at year 2, while the percentage was 23.0% for serogroup A. Using rSBA, but not hSBA, a high percentage of MenC-CRM197 recipients acquired antibody against serogroups A (82.1%), W (58.6%) and Y (80.0%). MenACWY-TT induced high level of bactericidal antibody in toddlers that persisted for at least 2 years.
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    ABSTRACT: In Deutschland werden Meningokokken-C(MenC)-Impfstoffe im Rahmen der allgemeinen Impfempfehlung eingesetzt. Daneben sind Polysaccharid- und Konjugatimpfstoffe gegen Meningokokken A, C, W135 und Y verfügbar. Die Anwendung erfolgt laut Ständiger Impfkommission (STIKO) als Indikationsimpfung. Anfang 2013 wurde ein rekombinanter 4-Komponenten-MenB(4CMenB)-Impfstoff zugelassen. Die ,,Abdeckung“ der in Europa zirkulierenden Stämme durch diesen Impfstoff beträgt ungefähr 80 %. Immunogenität und Sicherheit sind für unterschiedlichste Impfschemata im Säuglingsalter und darüber hinaus untersucht worden. Dabei waren bei Koadministration mit Routineimpfstoffen höhere Fieberraten zu beobachten. Für den 4CMenB-Impfstoff liegt noch keine STIKO-Empfehlung vor.
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    ABSTRACT: Invasive meningococcal disease is a serious infection that occurs worldwide. It is caused by Neisseria meningitidis, of which six serogroups (A, B, C, W-135, X, and Y) are responsible for most infections. The case fatality rate of meningococcal disease remains high and can lead to significant sequelae. Vaccination remains the best strategy to prevent meningococcal disease. Polysaccharide vaccines were initially introduced in the late 1960s but their limitations (poor immunogenicity in infants and toddlers and hyporesponsiveness after repeated doses) have led to the development and use of meningococcal conjugate vaccines, which overcome these limitations. Two quadrivalent conjugated meningococcal vaccines - MenACWY-DT (Menactra(®)) and MenACWY-CRM197 (Menveo(®)) - using diphtheria toxoid or a mutant protein, respectively, as carrier proteins have already been licensed in the US. Recently, a quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT; Nimenrix(®)) was approved for use in Europe in 2012. The immunogenicity of MenACWY-TT, its reactogenicity and safety profile, as well as its coadministration with other vaccines are discussed in this review. Clinical trials showed that MenACWY-TT was immunogenic in children above the age of 12 months, adolescents, and adults, and has an acceptable reactogenicity and safety profile. Its coadministration with several other vaccines that are commonly used in children, adolescents, and adults did not affect the immunogenicity of MenACWY-TT or the coadministered vaccine, nor did it affect its reactogenicity and safety. Other studies are now ongoing in order to determine the immunogenicity, reactogenicity, and safety of MenACWY-TT in infants from the age of 6 weeks.
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