General Information

Penbraya is a vaccine against Meningococcal Groups A, B, C, W, and Y.

Penbraya is specifically indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age.

Penbraya is supplied as a suspension for intramuscular injection. Administer 2 doses (approximately 0.5 mL each) of Penbraya 6 months apart.

Mechanism of Action

Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N. meningitidis. Vaccination with Penbraya induces the production of bactericidal antibodies specific to the capsular polysaccharides of N. meningitidis serogroups A, C, W, and Y and to fHbp subfamily A and B variants of N. meningitidis group B. The susceptibility of group B meningococci to bactericidal antibody is dependent upon both the antigenic similarity of the fHbp subfamily A or subfamily B vaccine antigen to the fHbp protein expressed by the bacterial strain and the amount of fHbp expressed at the bacterial surface.

Clinical Trial Results

The FDA approval of Penbraya (MenABCW) was based on results from Phase 2 and Phase 3 trials, including a randomized, active-controlled and observer-blinded Phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared to currently U.S. licensed meningococcal vaccines, with the goal of determining immunologic noninferiority. The Phase 3 trial evaluated more than 2,400 patients from the U.S. and Europe.

In the phase 3 trial, participants in the trial were randomly assigned to receive either two doses of MenABCWY or licensed vaccines (two doses of Trumenba + one dose of Menveo). Non-inferiority was demonstrated for all five serogroups following two doses of MenABCWY compared to two doses of Trumenba and one dose of Menveo.

Additionally, a single dose of MenABCWY met the non-inferiority criteria for serogroups A, C, W and Y compared to one dose of Menveo. Iin individuals who had not previously received a meningococcal vaccine, the proportion of subjects with ≥4-fold increases in immune responses was observed to be higher following either one or two doses of MenABCWY for serogroups A, C, W and Y compared to one dose of Menveo. Additionally, the proportion of subjects with ≥4-fold increases in immune responses was also observed to be higher against all four serogroup B strains following two doses of MenABCWY compared to two doses of Trumenba.