Bivalent MenB Vaccine Is Safe and Effective

The bivalent meningococcal B vaccine, MenB-FHbp, effectively protects adolescents and young adults against diverse strains of group C meningococcus bacteria, according to two phase 3 studies.

The studies included 3596 adolescents aged 10 to 18 years and 3304 young adults aged 18 to 25 years. Adolescents were randomly assigned to receive either the MenB-FHbp or hepatitis A vaccine and saline at baseline, and at 2 and 6 months. Young adults were randomly assigned to receive MenB-FHbpor or saline at baseline, and at 2 and 6 months.
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Primary endpoints evaluated were the proportion of participants who had experienced an increase in human complement (hSBA) titer for 4 primary strains of meningococcal by a factor of 4 or more, and the proportion of participants who had an hSBA titer at least as high as the lower limit of quantitation for all 4 strains combined after receiving the 3rd vaccine dose. In addition, the researchers assessed hSBA responses to the primary strains after dose 2 and safety of the vaccine.

Overall, the percentage of adolescents who had experienced an increase in hSBA against each primary strain ranged from 56% to 85.3% after dose 2 and from 78.8% to 90.2% after dose 3. Among young adults, the percentage of participants with an increase in hSBA against each primary strain after dose 2 and 3 ranged from 54.6% to 85.6% and 78.9% to 89.7%, respectively.

In addition, the composite responses were 53.7% after dose 2 and 82.7% after dose 3 among adolescents, and were 63.3% after dose 2 and 84.5% after dose 3 among young adults.

The majority of participants who received MenB-FHbp vaccine had reported mild or moderate pain at the injection site.

“MenB-FHbp elicited bactericidal responses against diverse meningococcal B strains after doses 2 and 3 and was associated with more reactions at the injection site than the hepatitis A virus vaccine and saline,” the researchers concluded.

—Melissa Weiss

Reference:

Ostergaard L, Vesikari T, Absalon J, et al; B1971009 and B1971016 Trial Investigators. A bivalent meningococcal B vaccine in adolescents and young adults [published online December 14, 2017]. N Engl J Med. doi:10.1056/NEJMoa1614474.