A phase 3 study to assess the immunogenicity, safety, and tolerability of MenB-FHbp administered as a 2-dose schedule in adolescents and young adults

Serum bactericidal activity against circulating and reference strains of meningococcal serogroup B in the United States: A review of the strain coverage of meningococcal serogroup B (MenB) vaccines in adolescents and young adults

“…In addition to the 3-dose series, immune responses to the 4 primary and 10 additional MenB test strains were recently evaluated in a phase 3, active-controlled, observer-blind, multicenter study in adolescents and young adults who received the 2-dose series of MenB-FHbp at 0 and 6 months ( Figure 2 ). 16 Similar to the data obtained from the 3-dose series, hSBA response rates at 1 month after dose 2 of MenB-FHbp ranged from 79.3% to 99.4% for the 4 primary MenB test strains and from 71.1% to 96.8% for the 10 additional strains. Genetic characterization of 432 MenB isolates from the United States showed that FHbp variants A22 and B24 are the most frequently occurring variants, and the 14 primary and additional test strains are representative of approximately 80% of circulating invasive strains in the United States and Europe.…”

“…Both MenB-FHbp and MenB-4C have demonstrated immunogenicity in adolescents and young adults when administered as a 2-dose series. 7 , 16 However, more data are available on the breadth of coverage of MenB-FHbp compared with MenB-4C in adolescents and young adults in the United States, and no phase 3 studies of MenB-4C have been conducted in this population. Immune responses may vary with geographic region, 20 and thus data from the United States are needed to fully assess the breadth of coverage of MenB vaccines in US adolescents and young adults.…”

“… Percentage of US adolescents and young adults with hSBA titers above threshold for primary and additional heterologous test strains before vaccination and 1 month after dose 2 of a 2-dose series of MenB-FHbp. 16 *hSBA thresholds are 1:16 for strains A06, A12, A19, and A22 and 1:8 for strains A07, A15, A29, A56, B03, B09, B15, B16, B24, and B44. Results are for the evaluable immunogenicity population for 4 test strains ( n = 829–861) and 10 additional strains ( n = 150–172).…”

Healthy vaccinee bias and MenB-FHbp vaccine effectiveness against gonorrhea

“…Because STI and vaccination data were obtained at the infection level, we classified vaccination data in relation to each STI. We assumed postvaccination immunity started 30 days after receipt of the first vaccine dose 20 . For this analysis, STIs that occurred ≥30 days after the date of the first MenB-FHbp dose were categorized as occurring after vaccination.…”

“…We assumed postvaccination immunity started 30 days after receipt of the first vaccine dose. 20 For this analysis, STIs that occurred ≥30 days after the date of the first MenB-FHbp were categorized as occurring after vaccination. Sexually transmitted infections that occurred before vaccination, among MenB-FHbp-naive persons, or occurred <30 days after first MenB-FHbp dose were categorized as STIs occurring among unvaccinated persons.…”