Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine (HibMenCY-TT; MenHibrix®): A Review
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The meningococcal groups C and Y and Haemophilus b (Hib) tetanus toxoid conjugate vaccine (HibMenCY-TT) contains Neisseria meningitidis serogroup C and Y capsular polysaccharide antigens, and Hib capsular polysaccharide [polyribosyl-ribitol-phosphate (PRP)]. The HibMenCY-TT vaccine is available in the USA for use as active immunization to prevent invasive disease caused by N. meningitidis serogroups C (MenC) and Y (MenY), and Hib in children 6 weeks–18 months of age. HibMenCY-TT is the first meningococcal vaccine available for use in the USA that can be administered to infants as young as 6 weeks of age. In a randomized, controlled, phase III clinical trial, the HibMenCY-TT vaccine, administered to infants at 2, 4, 6 and 12–15 months of age, was immunogenic against MenC and MenY, and met the prespecified criteria for immunogenicity. Anti-PRP antibodies, which have been shown to correlate with protection against Hib invasive disease, were also induced in the infants who received the HibMenCY-TT vaccine, with induced levels of this antibody noninferior to those occurring in the control group of infants who received a Hib tetanus toxoid conjugate vaccine at 2, 4, and 6 months and a single dose of Hib conjugated to N. meningitidis outer membrane protein at 12–15 months. In several randomized, controlled clinical trials, HibMenCY-TT was coadministered with vaccines that are routinely administered to infants and toddlers in the USA. These vaccines included: diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated poliovirus vaccine combined; 7-valent Streptococcus pneumoniae polysaccharide conjugate vaccine; measles, mumps and rubella vaccine; and varicella vaccine. Coadministration of these vaccines did not interfere with the immunogenicity of the HibMenCY-TT vaccine. Similarly, immune responses to the coadministered vaccines were not affected by the HibMenCY-TT vaccine. The tolerability profile of the HibMenCY-TT vaccine in infants and toddlers in the phase III trial was considered to be clinically acceptable and comparable to that of the Hib conjugate vaccines received by the control group.
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit.
- 1.World Health Organization. New and under-utilized vaccines implementation (NUVI). 2012. http://www.who.int/nuvi/meningitis/en/index.html. Accessed 22 Mar 2013.
- 2.World Health Organization. Bacterial meningitis (including Haemophilus influenzae type b (Hib), Neisseria meningitidis, and Streptococcus pneumoniae). 2012. http://www.who.int/immunization_monitoring/diseases/meningitis_surveillance/en. Accessed 22 Mar 2013.
- 14.GlaxoSmithKline. GSK Receives FDA Approval for MenHibrix. 2012. http://us.gsk.com/html/media-news/pressreleases/2012/2012-pressrelease-1134018.htm. Accessed 22 Mar 2013.
- 15.Marshall GS. Perspectives on immunization. J Manag Care Med. 2012;15(3):5–10.Google Scholar
- 20.Miller JM, Mesaros N, Van Der Wielen M, et al. Conjugate meningococcal vaccines development: GSK biologicals experience. Adv Prev Med. 2011;Article ID 846756.Google Scholar
- 21.Centers for Disease Control and Prevention (CDC). Updated recommendations for the use of meningococcal conjugate vaccines—Advisory Committee on Immunization Practices (ACIP), 2010. Morbidity and Mortality Weekly Report (MMWR). 2011;60:72–6.Google Scholar
- 24.GlaxoSmithKline. US prescribing information for MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) 2012. http://us.gsk.com/products/assets/us_menhibrix.pdf. Accessed 22 Mar 2013.
- 25.Centers for Disease Control and Prevention (CDC). Infant meningococcal vaccination: Advisory Committee on Immunization Practices (ACIP) recommendations and rationale. MMWR Morb Mortal Wkly Rep. 2013;62:52–4.Google Scholar
- 27.Robbins JB, Parke JC, Schneerson R, et al. Quantitative measurement of “natural” and immunization-induced Haemophilus influenzae type b capsular polysaccharide antibodies. Pediatr Res. 1973;7:103–10.Google Scholar
- 29.Anderson P. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis. 1984;149:1034–5.Google Scholar
- 31.Nolan T, Lambert S, Roberton D, et al. A novel combined Haemophilus influenzae type b–Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine is immunogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants. Vaccine. 2007;25(51):8487–99.PubMedCrossRefGoogle Scholar
- 33.Habermehl P, Leroux-Roels G, Sanger R, et al. Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2, 3, 4 months schedule with a fourth dose at 12–18 months of age. Hum. 2010;6(8):640–51.Google Scholar
- 35.Marshall GS, Marchant CD, Blatter M, et al. 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. Pediatr Infect Dis J. 2010;29(5):469–71.PubMedCrossRefGoogle Scholar
- 36.Marshall GS, Mesaros N, Aris E, et al. Persistence of immunity three years after an investigational haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y tetanus toxoid (HibMenCY-TT) conjugate vaccine (abstract no. 25219). In: Proceedings of the 45th National Immunization Conference, Washington, DC; 28–31 Mar 2011.Google Scholar
- 37.Marshall G, Blatter M, Marchant C, et al. Antibody persistence for up to 5 years after a fourth dose of Haemophilus influenzae type B and Neisseria Meningitidis serogroups C and Y-Tetanus Toxoid conjugate vaccine (Hibmency-TT) given at 12–15 months. Pediatr Infect Dis J. 2013. doi: 10.1097/INF.0b013e3182840e35.
- 38.Marshall GS, Marchant CD, Blatter M, et al. Co-administration of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine does not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States. Human Vaccines. 2011;7(2):258–64.PubMedCrossRefGoogle Scholar
- 39.Bryant KA, McVernon J, Marchant CD, et al. Immunogenicity and safety of measles–mumps–rubella and varicella vaccines coadminstered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis subgroups C and T-tetanus toxoid conjugate vaccine in toddlers. Human Vaccines Immunother. 2012;8(8):1036–41.Google Scholar