Trumenba® Meningitis B Vaccine Description
Trumenba® (MenB-FHbp) is a recombinant protein-based vaccine targeting Neisseria meningitidis serogroup B. 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).
The proteins are individually produced in E. coli. Production strains are grown in defined fermentation growth media to a specific density. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added to the drug substances and is present in the final drug product.
The Lancet Infectious Diseases reported on September 7, 2022, on the good immunogenicity, short-lived antibody persistence, and acceptable reactogenicity profile of meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp), which contains two factor-H-binding proteins, against serogroup B meningococcal disease in children aged 1–9 years. The data were collected during two phase 2 studies in Australia and Europe, with 396 toddlers (age 12–23 months) and 400 older children (aged 2–9 years) randomly assigned to receive either MenB-FHbp (60 μg [toddler study only] or 120 μg) or a control vaccine (hepatitis A vaccine and saline) in a three-dose primary schedule (0, 2, and 6 months). The strong immune response to a booster dose observed in the study can be interpreted as showing immune memory.
U.S. FDA STN: BL 125549 - Proper Name: Meningococcal Group B Vaccine - Trade Name: On October 29, 2014, the U.S. FDA sent an approval letter authorizing the introduction or delivery of Trumenba into interstate commerce. TRUMENBA. EMA: EMEA/H/C/004051.
Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B (Men B). The most current comprehensive recommendations from the Advisory Committee on Immunization Practices (ACIP) for meningococcal vaccines are available on the MMWR website at www.cdc.gov/mmwr/volumes/69/rr/pdfs/rr6909a1-H.pdf.
Trumenba is intended for intramuscular injection administered as a two or three-dose series in individuals 10 through 25 years of age following a 0-, 2-, and 6-month schedule. In addition, the two-dose series is recommended for healthy adolescents (16) and young adults.
September 15, 2022 - Pfizer Inc. announced positive top-line results from the pivotal Phase 3 trial assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY). Non-inferiority was demonstrated for all five serogroups following two doses of MenABCWY compared to two doses of Trumenba®and one dose of Menveo®.
Trumenba Clinical Trials
Pfizer's Trumenba has been involved in over ten clinical trials to test its safety, tolerability, and immunogenicity.