A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults

Controlling serogroup B invasive meningococcal disease: the Canadian perspective

“…In a similarly designed study [65], 48 participants 18-40 years of age were randomized to receive three doses at 0, 2 and 6-9 months of 60, 120 or 200 µg of the bivalent rLP2086 vaccine or an adult formulation of diphtheria tetanus acellular pertussis vaccine (Tdap; first dose or placebo, second and third doses). Antibody responses were demonstrated against both subfamily A and B LP2086 for all three dose levels without an apparent dose response; however, geometric mean antibody levels increased with subsequent doses.…”

The Discovery and Development of a Novel Vaccine to Protect againstNeisseria meningitidisSerogroup B Disease

“…The resulting final formulation was used for all subsequent clinical studies including a Phase 1 Study (B1971004) and a Phase 1/2 Study (B1971003) conducted in subjects 18 to 40 y of age, where the final selected dose level of 120 µg (60 µg of rLP2086 variant A05 and 60 µg of rLP2086 variant B01) was confirmed. 33,34 The potential for bivalent rLP2086 to generate broadly Figure 5. Overview of the MeASURe assay.…”

Role of Factor H Binding Protein in Neisseria meningitidis Virulence and Its Potential as a Vaccine Candidate To Broadly Protect against Meningococcal Disease

“…Published studies are available that describe the clinical trial results with both the initial (81,128,129) and final (80,130,137) formulations of Pfizer's bivalent rLP2086 vaccine. However, a comprehensive review of clinical findings for Pfizer's bivalent rLP2086 vaccine is not yet available.…”

“…Initial dose ranging studies with an initial formulation of the bivalent rLP2086 vaccine were conducted in adults (81), adolescents (129), and toddlers (128) using dose levels of 20 g, 60 g, and 200 g of vaccine. An additional dose ranging phase 2 study with the final vaccine formulation (60 g, 120 g, and 200 g) was conducted in adults (137) and adolescents (80). Based on the hSBA immunogenicity and tolerability profiles observed in the adolescent phase 2 study with the final vaccine formulation, the 120-g dose level was selected for further clinical development (80).…”