Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data

Abstract

Introduction: An extensive clinical development program showed that the meningococcal serogroup B-factor H binding protein (MenB-FHbp) vaccine affords protection against MenB disease for adolescents and adults. Data were pooled from multiple studies within the program to examine whether MenB-FHbp immunogenicity was influenced by sex, age, or race. Methods: Immunogenicity was assessed in subjects from seven studies who received 120 lg MenB-FHbp (at 0, 2, 6 months) and had evaluated immune responses against four representative test strains via serum bactericidal assays using human complement (hSBAs). Immune responses were presented by sex (male, female), age group (10-14, 15-18, 19-25, 10-25 years), and race (white, black, Asian, other). Results: Among 8026 subjects aged 10-25 years included in this analysis, MenB-FHbp elicited robust immune responses in a high percentage of subjects regardless of demographic characteristics. Across all test strains and demographic subsets, a C 4-fold rise in titer from baseline was achieved in 76.7-95.0% of subjects, with no major differences by sex, age groups assessed, or races evaluated. Corresponding percentages achieving titers C the lower limit of quantification (LLOQ) against all four strains combined were 79.7-87.3% (sex), 81.6-85.5% (age), and 80.0-88.1% (race). Minor differences were observed for geometric mean titers and percentages of subjects achieving titers C LLOQ against each strain based on demographics. Conclusion: These data suggested no clinically meaningful differences in MenB-FHbp immunogenicity when administered as a threedose schedule based on sex, ages assessed, or races evaluated. This analysis supports the continued recommended use of MenB-FHbp to prevent MenB disease in adolescents and young adults.

Human and Veterinary Vaccines for Lyme Disease

“…Factor H binding proteins have been investigated as potential vaccine candidates. The fHbp protein of Neisseria meningitidis (Beernink and Granoff, 2009), has been s u c c e s s f u l l y d e v e l o p e d a s a v a c c i n e f o r meningococcal disease caused by type B Neisseria meningitidis (Beeslaar et al, 2020a;Beeslaar et al, 2020b;Borrow et al, 2020). FHbp is the main vaccinogen in two FDA approved and licensed vaccines: Bexsero ® (GlaxoSmithKline) and Trumenba ® (Pfizer).…”

On the Road to Individualization of Vaccination: the Significance of Age and Sex

“…Есть исследования, в которых не обнаружили влияния пола на иммунологическую эффектив ность вакцинации. В работе Beeslaar J с соавт., в которой также анализировалось влияние воз раста, не выявлена роль пола, что обусловлено схемой исследования -трехдозовая иммунизация, оценка по 4кратному увеличению титра антител, возраст вакцинированных до 25 лет, что, конечно, повлияло на результат [20]. Действительно, еще раньше (2008 г.…”

Development of an FhbB based chimeric vaccinogen that elicits antibodies that block Factor H binding and cleavage by the periopathogen Treponema denticola

“…Precedent for the development of FH binding protein‐based vaccines is well‐established. The type B meningococcal vaccines, Bexsero ® (GlaxoSmithKline) and Trumenba ® (Pfizer) (Beeslaar, Absalon, et al., 2020; Beeslaar, Peyrani, et al., 2020; Borrow et al., 2020) both employ wild‐type FH binding proteins . Beernink and colleagues have demonstrated that site‐directed mutations introduced into FHbp that decrease FH binding resulted in superior complement‐mediated serum anti‐FHbp bactericidal responses than wild‐type FHbp in human FH transgenic mice (Beernink, Shaughnessy, et al, 2011; Beernink, Shaughnessy, et al, 2012and rhesus macaques 2016; Beernink, Vianzon, et al, 2019.…”