Rates of meningococcal disease are highest in infancy, but until recently no meningococcal vaccine was approved for use in this age group. MenHibrix (GSK), a new conjugate vaccine that protects against Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib), has been approved by the FDA for use in infants ≥6 weeks old and Menveo, a meningococcal vaccine already approved for patients ≥2 years old that protects against serogroups A, C, Y, and W-135, is now approved for use in infants ≥2 months old.
SEROGROUPS — Five major serogroups of N. meningitidis, A, B, C, Y, and W-135, cause most of the reported cases of invasive meningococcal disease. Serogroup A is the leading cause of epidemic meningitis worldwide, especially in the meningitis belt of sub-Saharan Africa, but it is rare in the US. Serogroup B causes about 60% of all meningitis cases in infants and, together with serogroups C and Y, accounts for most of the endemic disease in the US. Serogroup W-135 has caused outbreaks worldwide, particularly among pilgrims to Mecca during the Hajj and their close contacts on arriving home. Serogroup B remains the only major serogroup for which no vaccine is available in the US. A meningococcal B vaccine (Bexsero – Novartis) is licensed in Europe and Australia for patients ≥2 months old.
IMMUNOLOGIC STUDIES — FDA approval of both MenHibrix and Menveo (for this age group) was based on immunologic studies in infants who received the vaccines at 2, 4, 6, and 12 months. Both vaccines produced protective antibody responses in almost all vaccinated infants. With MenHibrix, antibody levels against Hib were non-inferior to those with 2 standard monovalent Hib vaccines.1
RECOMMENDATIONS FOR USE — The CDC’s Advisory Committee on Immunization Practices (ACIP) does not recommend routine vaccination against meningococcal disease for infants. It does recommend use of either MenHibrix or Menveo for infants who are at increased risk of meningococcal disease because of persistent complement deficiencies, functional or anatomic asplenia, or exposure to a community outbreak of disease caused by one of the serogroups in the vaccine.2 Menveo is also recommended for infants traveling with their families to the Hajj or to the meningitis belt of sub-Saharan Africa. Both vaccines can be given on a 4-dose schedule at 2, 4, 6, and 12 months, but the first dose of MenHibrix can be administered as early as 6 weeks and the last dose as late as 18 months.