Trumenba, a bivalent meningococcal B vaccine, is safe and immunogenic in adolescents and young adults after two and three doses, according to the results of two phase 3 trials.
In the trials, Trumenba (MenB-FHbp, Pfizer) caused more injection-site reactions than hepatitis A virus vaccine or saline, Lars Østergaard, MD, PhD, of the clinical medicine and infectious diseases departments of Aarhus University Hospital in Denmark, and colleagues reported in The New England Journal of Medicine.
The FDA approved MenB-FHbp in 2014 for prevention of Neisseria meningitidis serogroup B among individuals aged 10 to 25 years. According to Østergaard and colleagues, meningococcal B accounts for a large proportion of invasive meningococcal disease in the United States, Europe and other regions.
“Neisseria meningitidis causes invasive meningococcal disease, which occurs predominantly in infants, adolescents, and young adults,” they wrote. “Patients frequently present with symptoms similar to those of meningitis or septicemia. Death occurs in up to 15% of infected persons, and up to 20% of survivors have long-term impairments.”
Currently, the CDC’s Advisory Committee on Immunization Practices suggests administering three doses of MenB-FHbp at baseline, 1 to 2 months and 6 months to adults who are at an increased risk for meningococcal disease and during outbreaks of the disease, and two doses at baseline and 6 months to adults who are not at an increased risk for meningococcal disease.
To evaluate the performance of the vaccine, Østergaard and colleagues randomly assigned 3,596 adolescents aged 10 to 18 years to receive MenB-FHbp or HAV vaccine and saline and 3,304 young adults aged 18 to 25 years to receive MenB-FHbp or saline at baseline, 2 months and 6 months.
In the modified intent-to-treat population, hSBA titers increased by a factor of at least 4 against the four primary test strains of meningococcal B in 56% to 85.3% of adolescents after two doses of MenB-FHbp and from 78.8% to 90.2% of adolescents after three doses, the researchers said. The percentages among young adults in the modified intent-to-treat population ranged from 54.6% to 85.6% and 78.9% to 89.7% after two and three doses, respectively.
Østergaard and colleagues said most recipients of MenB-FHbp reported mild or moderate pain at the vaccination site.
“Broadly protective hSBA responses were observed in both of these phase 3 trials after three doses of MenB-FHbp ... and primary immunogenicity end points were met,” they wrote. “Immune responses were also reported after the first and second doses. These results are consistent with those from phase 2 licensure trials.”– by Gerard Gallagher
Disclosures: Østergaard reports other support from Pfizer while conducting the study and personal fees from Pfizer outside the submitted work. Please see the study for all other authors’ relevant financial disclosures.