4CMenB Breadth of Immune Response, Immunogenicity, and Safety: Results From a Phase 3 Randomized, Controlled, Observer Blind Study in Adolescents and Young Adults


Nolan T., Bhusal C., Beran J., Bloch M., ÇETİN B. Ş., DİNLEYİCİ E. Ç., ...Daha Fazla

OPEN FORUM INFECTIOUS DISEASES, sa.11, 2024 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Basım Tarihi: 2024
  • Doi Numarası: 10.1093/ofid/ofae638
  • Dergi Adı: OPEN FORUM INFECTIOUS DISEASES
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, Directory of Open Access Journals
  • Eskişehir Osmangazi Üniversitesi Adresli: Evet

Özet

Invasive meningococcal disease, caused by the bacterium Neisseria meningitidis, is life-threatening but can be prevented with vaccination. There are effective vaccines against different meningococcal serogroups, including serogroup B. Evidence from immunization programs with the 4-component meningococcal serogroup B vaccine, 4CMenB, over the past decade confirms its effectiveness and positive impact against serogroup B disease in people of all age groups. To assess the performance of serogroup B vaccines in clinical trials, tests are required that take into account the wide diversity of serogroup B strains circulating in the population. In this study, the performance of 4CMenB was evaluated using the enc-hSBA assay, which uses the complement (proteins) present in each vaccinated person's blood and is used to test a large number of N meningitidis strains, thereby determining breadth of immune response, based on the vaccine's killing activity against diverse strains. Using this assay, our results showed breadth of immune response following administration of 4CMenB (2 doses, 2 or 6 months apart) against the 110 serogroup B strains tested that was consistent with its performance in immunization programs, with no additional benefit from administering 3 4CMenB doses over the 6-month period. The safety of 4CMenB was consistent with its known safety profile.Clinical Trial Registration. NCT04502693.