Studies demonstrate immunogenicity of Trumenba against MnB
Posted: 13 May 2016 | | No comments yet
Pfizer has announced results of two Phase III studies demonstrating the immunogenicity of Trumenba against invasive meningococcal B strains…
Pfizer has announced results of two Phase III studies demonstrating the immunogenicity of Trumenba (Meningococcal Group B Vaccine) against invasive meningococcal B (MnB) strains representative of prevalent strains in the US and Europe.
The two studies, one in adolescents and one in young adults, met all primary immunogenicity endpoints. Also, secondary data presented show that Trumenba demonstrated similar immune responses against ten additional MnB strains, in both adolescents and young adults. The data continue to support the vaccine’s current safety and tolerability profile.
“Trumenba is designed to provide protection against serogroup B meningococcal disease,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. “The Phase III data show that Trumenba elicits an immune response that is effective against prevalent meningococcal serogroup B strains in the US and Europe, as well as 10 additional strains of this unpredictable disease. These data support the expectation that vaccination with Trumenba will help prevent this uncommon, but devastating disease in adolescents and young adults.”
Results support global regulatory submissions for Trumenba
Pfizer says these Phase III data support additional upcoming global regulatory submissions and the planned US supplement to request the conversion of Accelerated Approval to Traditional Approval for Trumenba.
Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A and one from subfamily B (A05 and B01, respectively). fHBP is one of many proteins found on the surface of meningococci and contributes to the ability of the bacterium to avoid host defenses. fHBPs can be categorized into two immunologically distinct subfamilies, A and B. The susceptibility of serogroup B meningococci to complement-mediated, antibody-dependent killing following vaccination with Trumenba is dependent on both the antigenic similarity of the bacterial and vaccine fHBPs, as well as the amount of fHBP expressed on the surface of the invading meningococci.
In October 2014, Trumenba was granted Accelerated Approval by the US Food and Drug Administration (FDA) for active immunisation to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. In 2015, the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended serogroup B meningococcal vaccination for certain persons aged 10 years and older at increased risk for meningococcal disease. They also recommended that a MnB vaccine series may be administered to adolescents and young adults 16 through 23 years of age (preferred age 16 through 18) to provide short term protection against most strains of MnB disease.