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Another vaccine for meningococcal disease may be moving toward licensure
An investigational vaccine for meningococcal disease was well-tolerated and yielded a stronger immune response in adolescents than the currently-licensed meningococcal vaccine, and these results may lead to another vaccine approval, according to findings presented by Carol Baker, MD, professor of pediatric molecular biology and microbiology at Baylor College of Medicine.
At the Interscience Conference on Antimicrobial Agents and Chemotherapy meeting in San Francisco, Baker reviewed some data that had been published by Jackson et al in Clinical Infectious Diseases.
The researchers compared the safety and immunogenicity of the investigational quadrivalent meningococcal CRM (197) conjugate vaccine MenACWY-CRM (Novartis) with the licensed meningococcal conjugate vaccine, Menactra (Sanofi Pasteur).
The researchers randomly assigned 2,180 adolescents ages 11 to 18 years to four groups in a 1:1:1:1 ratio. The participants received one of three lots of MenACWY-CRM or a single dose of Menactra.
The researchers had obtained serum samples prior to vaccination and one month after vaccination. The samples were tested for serogroup-specific serum bactericidal activity using human complement. The human complement titers for each vaccine were compared.
The human complement geometric mean titers in participants receiving the MenACWY-CRM vaccine were higher than those in the Menactra group. Superiority criteria for this endpoint were met for all serogroups.
Mild and/or moderate adverse reactions were reported by 64% of the participants in the MenACWY-CRM group and 70% of the participants in the Menactra group.
“These results very likely could lead to another license,” Baker said. “We are not yet certain about the duration of protection for the investigative drug, and questions remain about herd immunity. But for now, these results look promising.”
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