Immunogenicity, reactogenicity, and safety of a reduced-interval 4CMenB primary immunisation schedule in UK infants: a multicentre, open-label, assessor-blinded, phase 4 randomised controlled trial

作者：Thorn N, Danos Z, Andrews NJ, Sutton N, Cathie K, Owens D, Kelly D, Shackley F, Scorrer T, Lea C, Collinson A, Miah T, Lewis-Bridgeman J, Pearce J, Borrow R, Louth J, Bell A, Ladhani SN, Heath PT · 发表于：The Lancet. Infectious diseases · 年份：2026 · DOI：10.1016/S1473-3099(26)00119-2 · 研究领域：Meningococcal Vaccines、Immunization Schedule、Meningococcal Infections、Immunogenicity, Vaccine、Humans、Infant、United Kingdom、Female、Male、Antibodies, Bacterial、Pneumococcal Vaccines

BACKGROUND: Until July, 2025, infants in the UK received the four-component meningococcal B vaccine (4CMenB) at ages 8 weeks and 16 weeks, boosted at 1 year. 4CMenB introduction was associated with large reductions in serogroup B (MenB) invasive meningococcal disease in childhood (cases now peak at age 3 months vs age 5-6 months before routine immunisation). A shorter interval between 4CMenB priming doses could reduce cases further. This study aimed to compare the immunogenicity, reactogenicity, and safety of 4CMenB priming schedules. METHODS: This multicentre, open-label, assessor-blinded, phase 4, randomised controlled trial compared reduced-interval 4CMenB (Group 1) priming at ages 8 and 12 weeks and 13-valent pneumococcal conjugate vaccine (PCV13) at 16 weeks with the standard-schedule 4CMenB (Group 2) at ages 8 and 16 weeks and PCV13 at 12 weeks, via computer-generated block randomisation (1:1). 4CMenB and PCV13 boosters were given at 1 year. Six hospitals in England enrolled full-term, unvaccinated, immunocompetent infants without previous invasive meningococcal disease. Participants received 4CMenB and PCV13 doses of 0·5 mL, intramuscularly. Blood samples obtained at post-primary, pre-booster, and post-booster timepoints were tested by masked staff for human serum bactericidal antibody (hSBA) against three MenB reference strains (44/76-SL: fHbp, 5/99: NadA, and NZ98/254: PorA), and serotype-specific pneumococcal antibodies against 12 PCV13 serotypes. The primary outco...