Abstract
Background
MenB-FHbp (bivalent rLP2086), a meningococcal serogroup B vaccine, is approved in several countries for adolescents and young adults. MenB-FHbp elicited robust immune responses and had an acceptable safety profile during an extensive clinical development program. Because immune responses to vaccines can vary by subject demographics, this subgroup analysis pooled data across 7 randomized MenB-FHbp clinical studies to evaluate potential differences in immunogenicity by sex, age, or race/ethnicity in a larger dataset relative to individual studies.
Methods
Data from subjects who received 120 µg MenB-FHbp at 0, 2, and 6 months and had valid immunogenicity results for 4 vaccine-heterologous test strains were included. Immune responses were evaluated by serum bactericidal assays using human complement (hSBA). Immunogenicity endpoints (assessed 1 month after dose 3) were percentages of subjects achieving ≥ 4-fold rise in hSBA titer against each strain, percentages achieving hSBA titers ≥ the lower limit of quantification (LLOQ) against each strain and against all 4 strains combined (composite response), geometric mean hSBA titers against each strain, and percentages achieving hSBA titers ≥ 1:4 (correlate of protection) against each strain.
Results
This analysis included 8026 subjects aged 10‒25 years (51.7% males, 80.7% adolescents aged 10‒18 years, 87.0% white, 9.3% black, 0.8% Asian, 3.0% other race). One month after dose 3, percentages of subjects achieving a ≥ 4-fold rise from baseline titer against each strain and achieving a composite response were similar across age and race (table). A marginally greater percentage of males vs. females achieved ≥ 4-fold rise in titer against each strain, but these differences were not considered clinically meaningful because of the high percentages of responders in both groups.
Conclusion
MenB-FHbp immunogenicity was similar across sex, age, and race in this pooled analysis, with high percentages of responders in all evaluated subgroups. The marginally lower response rates among females compared with males were not considered clinically meaningful. These findings support currently recommended MenB-FHbp vaccination practices without modification by sex, age, or race.
Funding: Pfizer
Disclosures
All authors: No reported disclosures.