1. Healthy adolescents and young adults treated with the Neisseria meningitidis vaccine MenB-FHbp had increased bactericidal antibody responses (hSBA titer) compared to those treated with control vaccines.
2. More localized injection-site reactions occurred among patients treated with the meningococcal B vaccine compared to control vaccines.
Evidence Rating Level: 2 (Good)
Study Rundown: Neisseria meningitidis infection remains a pervasive health concern for infants, adolescents, and young adults. Though validated capsular polysaccharide-based vaccines exist for common meningitis serogroups A, C, W and Y, vaccines for the invasive disease-causing meningitis serogroup B have only recently been introduced. This multicenter, phase 3 randomized control trial assessed the immunogenicity and safety profile of MenB-FHbp, a meningococcal B vaccine that contains surface-exposed factor H-binding protein in two separate cohorts of adolescents and young adults. The primary objective was evaluation of an observed immune response to 4 primary test strains of meningococcal B measured one month after participants’ 3rd vaccination dose. A broad immunogenic response was observed to the MenB-FHbp vaccine, evidenced by increased antibody titers, after the treatment period across all primary meningococcal B strains tested. From a safety standpoint, localized injection-site pain was noted as the most common adverse reaction in both meningococcal vaccine and control treated patients. This study demonstrates broad bactericidal response to various meningococcal B strains after vaccination, though clinical efficacy for reducing meningococcal disease will require further study.
Click to read the study, published in NEJM
Relevant Reading: Updated recommendations for use of menB-FHbp serogroup B meningococcal vaccine – advisory committee on immunization practices, 2016
In-Depth [randomized controlled trial]: This phase 3, observer-blinded, multicenter randomized control trial included 3596 and 3304 healthy adolescents (10-18 years old) and young adults (18-25), respectively. Adolescents were randomized to receive intramuscular injections of either MenB-FHbp or hepatitis A with saline. Young adults were randomized to receive either MenB-FHbp or saline. All participants received injections at timed intervals of 0, 2, and 6 months post-randomization. Of those randomized, 3272 (91.0%) adolescents and 2474 (74.9%) young adults completed the vaccination schedule. The primary endpoint was measured by determining the percent of participants who exhibited an increase in hSBA titer activity by at least a factor of 4 after their third vaccination. Adolescents in the meningococcal vaccine groups who met this criterion ranged from 78.8% to 90.2%, depending on the meningococcal B strain tested (A22, A56, B24, and B44). This percent ranged from 78.9% to 89.7% of young adults. By comparison, percentages in both control groups were noted to be 11.0% or less. Composite hSBA titer response were 82.7% in adolescents and 84.5% in young adults randomized to receive MenB-FHbp; the composite response was 7.4% or less in control groups. The overall frequency of adverse events was comparable between treatment and control groups for both trial cohorts. There were a total of 51 serious adverse events in the adolescent active-treatment arm compared to 22 in the adolescent control arm; none were deemed study-related. By comparison, there were 33 serious adverse events in the young adult active-treatment arm and 11 in the young adult control arm; 3 events or 1.3% of the active arm events were deemed vaccine-related.
Image: PD
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