Updated Recommendations for Use of MenB-FHbp Serogroup B Meningococcal Vaccine - Advisory Committee on Immunization Practices, 2016

Abstract

Two serogroup B meningococcal (MenB) vaccines are currently licensed for use in persons aged 10-25 years in the United States. The two vaccines are MenB-FHbp (Trumenba, Pfizer, Inc.) (1) and MenB-4C (Bexsero, GlaxoSmithKline Biologicals, Inc.) (2). In February 2015, the Advisory Committee on Immunization Practices (ACIP) recommended use of MenB vaccines among certain groups of persons aged ≥10 years who are at increased risk for serogroup B meningococcal disease* (Category A) (3), and in June 2015, ACIP recommended that adolescents and young adults aged 16-23 years may be vaccinated with MenB vaccines to provide short-term protection against most strains of serogroup B meningococcal disease (Category B^†) (4). Consistent with the original Food and Drug Administration (FDA) licensure for the two available MenB vaccines, ACIP recommended either a 3-dose series of MenB-FHbp or a 2-dose series of MenB-4C. Either MenB vaccine can be used when indicated; ACIP does not state a product preference. The two MenB vaccines are not interchangeable; the same vaccine product must be used for all doses in a series. In April 2016, changes to the dosage and administration of MenB-FHbp were approved by FDA to allow for both a 2-dose series (administered at 0 and 6 months) and a 3-dose series (administered at 0, 1-2, and 6 months) (5,6). In addition, the package insert now states that the choice of dosing schedule depends on the patient's risk for exposure and susceptibility to serogroup B meningococcal disease. These recommendations are regarding use of the 2- and 3-dose schedules of MenB-FHbp vaccine (Trumenba) and replace previous ACIP recommendations for use of MenB-FHbp vaccine published in 2015 (3,4). Recommendations regarding use of MenB-4C (Bexsero) are unchanged (3,4).

FIGURE 1

Persistence of hSBA responses ≥1:4 against four selected serogroup B meningococcal strains in subjects aged 11–18 years, up to 48 months (m) after completion of a 2-dose (0, 6 months) or 3-dose (0, 2, 6 months) series of MenB-FHbp Abbreviation: hSBA = serum bactericidal antibody activity, measured using human complement. * Expressed as a percentage, with error bars representing 95% confidence intervals. ^† Serogroup B meningococcal strains expressing FHbp (factor H binding protein) of subfamily A (A22, A56) or subfamily B (B24, B44). ^§ Number of subjects for persistence time points: 0, 6 m = 99–116; 0, 2, 6 m = 92–114.

FIGURE 2

Persistence of hSBA responses ≥1:4 and GMTs against four selected serogroup B meningococcal strains at 48 months (m) in subjects aged 11–18 years after completion of a 2-dose (0, 6 months) or 3-dose (0, 2, 6 months) series of MenB-FHbp, and hSBA responses ≥1:4 and GMTs to a booster dose of MenB-FHbp at approximately 48 months after primary vaccination Abbreviations: GMTs = geometric mean antibody titers; hSBA = serum bactericidal antibody activity, measured using human complement. * Expressed as a percentage, with error bars representing 95% confidence intervals. ^† GMTs were as follows. A22 (0, 6 m): Pre 6.4, 1m post primary 55.8, 48m post primary 15.3, 1m post booster 140.0; (0, 2, 6m): Pre 6.3, 1m post primary 59.5, 48m post primary 15.4, 1m post booster 119.1. A56 (0, 6m): Pre 6.7, 1m post primary 143.1, 48m post primary 15.8, 1m post booster 358.0; (0, 2, 6m): Pre 6.1, 1m post primary 191.2, 48m post primary 17.4, 1m post booster 370.8. B24 (0, 6m): Pre 5.0, 1m post primary 29.2, 48m post primary 7.8, 1m post booster 86.0; (0, 2, 6m): Pre 5.1, 1m post primary 30.5, 48m post primary 9.1, 1m post booster 80.3. B44 (0, 6m): Pre 4.5, 1m post primary 35.5, 48m post primary 5.3, 1m post booster 84.6; (0, 2, 6m): Pre 4.5, 1m post primary 50.2, 48m post primary 5.3, 1m post booster 117.6. ^§ Serogroup B meningococcal strains expressing FHbp (factor H binding protein) of subfamily A (A22, A56) or subfamily B (B24, B44). ^¶ Number of subjects for persistence time points: 0, 6 m = 58–62; 0, 2, 6 m = 57–58.