Immune response and one-year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age.

Department of Pediatrics, University of Louisville School of Medicine, Louisville, KY 40202, USA.
The Pediatric Infectious Disease Journal (Impact Factor: 2.72). 05/2010; 29(5):469-71. DOI: 10.1097/INF.0b013e3181cdd379
Source: PubMed

ABSTRACT A total of 236 infants received a fourth Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) dose at 12 to 15 months. One month later, the proportion with anti-PRP antibody > or =1.0 microg/mL and bactericidal titers > or =1:8 to MenC and MenY was 98.9%, 96.9%, and 95.4%, respectively. One year later, anti-PRP concentrations > or =0.15 microg/mL, and MenC and MenY bactericidal titers > or =1:8 persisted in 100%, 96.6%, and 83.8%, respectively. The safety profile of HibMenCY was comparable to Hib.

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    • "HibMenCY-TT is recommended by the Advisory Committee on Immunization Practices (ACIP) for use in infants and children at increased risk for IMD such as those with complement deficiencies or asplenia including sickle cell disease, and may be used as an alternative for routine vaccination against Hib [8]. Immunogenicity and safety of HibMenCY-TT was demonstrated in clinical trials conducted in infants and toddlers [9] [10] [11] [12] [13] [14] [15] [16]. The quadrivalent serogroups A/C/W and Y meningococcal conjugate vaccine MenACWY-CRM 197 (Menveo TM , Novartis) is also approved in the US as a four-dose series in infants, and Menactra TM (MenACWY-DT, Sanofi Pasteur) is approved as a two-dose schedule in children aged 9–23 months. "
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    ABSTRACT: Background: Immunogenicity and safety of a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT were evaluated in the second year of life in HibMenCY-TT-primed toddlers. Methods: Healthy infants were randomized (5:1) and primed at 2, 4 and 6 months of age with HibMenCY-TT and diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus (DTaP-HBV-IPV) vaccine; or Hib-TT and DTaP-HBV-IPV (control). Recipients of HibMenCY-TT+DTaP-HBV-IPV were re-randomized (2:2:1) to receive MenACWY-TT at 12-15 months and DTaP at 15-18 months; MenACWY-TT co-administered with DTaP at 15-18 months; or HibMenCY-TT at 12-15 months and DTaP at 15-18 months. Controls received DTaP only at 15-18 months due to Hib conjugate vaccine shortage. Serum bactericidal activity using human complement (hSBA) and safety were assessed one month after meningococcal vaccination. Results: After vaccination with MenACWY-TT at 12-15 months or MenACWY-TT+DTaP at 15-18 months, all subjects previously primed for serogroups C/Y had hSBA ≥1:8 for these serogroups. At least 96.1% also had hSBA ≥1:8 for serogroups A/W. All subjects in the HibMenCY-TT group had hSBA ≥1:8 for serogroups C/Y. All pre-defined statistical criteria for meningococcal immunogenicity were satisfied. All vaccination regimens had acceptable safety profiles. Conclusion: Children primed with three doses of HibMenCY-TT who then received a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT had robust increases in hSBA titers for serogroups C/Y. These data provide support that MenACWY-TT, given with or without the fourth scheduled dose of DTaP could be administered as an alternative to a fourth dose of HibMenCY-TT in the second year of life. This study (110870/110871) is registered at NCT00614614.
    Vaccine 08/2014; 33(7). DOI:10.1016/j.vaccine.2014.08.027 · 3.62 Impact Factor
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    • "The US infant study showed that MenC and Y antibody responses were higher in infants vaccinated with HibMenCY-TT than in the control 3- to 5-year-old children who received a single dose of MenACWY-PS vaccine [33]. Higher antibody titers of MenC and Y were also observed post fourth dose of HibMenCY-TT as compared with a single dose of HibMenCY at 12–15 months, providing evidence of immune memory [34]. There was no immune interference to any concomitantly administered antigens with HibMenCY-TT in infancy (Streptococcus pneumoniae serotypes contained in PCV7 or diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens contained in DTPa-HBV-IPV) or in anti-pneumococcal antibody concentrations after the fourth HibMenCY-TT dose [35]. "
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    ABSTRACT: The highest incidence of meningococcal disease occurs in infants younger than 1 year of age. However, in the US, prior to June 2012, there was no meningococcal vaccine licensed for use in this age group. In the US, where both serogroups C and Y contribute substantially to the overall epidemiology of invasive meningococcal disease, a vaccine combining these capsular polysaccharides was developed. We review the newly licensed HibMenCY-TT (MenHibrix™, GlaxoSmithKline Biologicals, Rixensart, Belgium), a novel vaccine containing Haemophilus influenzae type b (Hib) and serogroups C and Y Neisseria meningitidis conjugated to tetanus toxoid. We describe the vaccine, summarize the clinical trial data, and describe the patient populations recommended to receive HibMenCY-TT as their primary vaccination against Hib. Phase II and III clinical trials found HibMenCY-TT to be well tolerated, safe, and immunogenic when administered at 2, 4, 6, and 12–15 months of age for primary vaccination against both Hib and serogroups C and Y meningococcal disease. In October 2012, the Advisory Committee on Immunisation Practice in the US recommended HibMenCY-TT vaccination for infants at increased risk of meningococcal disease. HibMenCY-TT may be given concomitantly with other routine infant vaccines. It induces antibodies against Hib as well as bactericidal activity against meningococcal serogroup C and Y without increasing the number of injections required. As meningococcal disease epidemiology is dynamic, global surveillance remains essential. In the future, other countries may also benefit from the addition of HibMenCY-TT into their vaccine armamentarium against meningococcal disease.
    06/2013; 2(1). DOI:10.1007/s40121-013-0007-5
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    • "Previous studies showed that a novel, combined Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroups C and Y conjugate vaccine that uses tetanus toxoid as carrier protein (HibMenCY-TT) was immunogenic with an acceptable safety profile when administered to infants as a 3-dose primary series,1-5 with a fourth dose in the second year of life.2,4-6 "
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    ABSTRACT: A pooled analysis was conducted of 1257 toddlers who received a fourth dose of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) or Hib conjugate vaccine (Hib polysaccharide conjugated to N. meningitidis outer membrane protein) coadministered with measles-mumps-rubella (MMR) and varicella (VAR) vaccines (NCT00134719/NCT00289783). Noninferiority of immunological responses to MMR and VAR was demonstrated between groups and incidences of MMR- and VAR-specific solicited symptoms were similar, indicating that HibMenCY-TT can be coadministered with MMR and VAR.
    Human Vaccines & Immunotherapeutics 08/2012; 8(8). DOI:10.4161/hv.20357 · 2.37 Impact Factor
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