Immunogenicity and safety of monovalent RIVMmeningococcal B OMP vesicle F91 vaccine administered to children that received hexavalent meningococcal B vaccine 2.5years ago

摘要

This report describes the results with respect to immunogenicity as wellas reactogenicity of a monovalent P1.7h,4 OMV vaccine (MonoMen) used asbooster vaccination in children previously vaccinated with a hexavalentMenB vaccine. The participants in this study were immunised in 1995-1996with hexavalent MenB vesicle vaccine or with hepatitis B vaccine (controlgroup). The booster vaccination with MonoMen was well tolerated. Noserious adverse events occurred during the study. Most systemic adversereactions were observed during day 2 and 3. Local reactions, whichgenerally lasted for three days, were more common than systemicreactions. The rise of the GMT of bactericidal antibodies againstP1.7h,4 in children primed with MenB was much higher as compared tochildren who received the HepB vaccine. About 80% of the children withan immune response after the primary series with the hexavalent vaccine,also showed an immune response after the booster vaccination with MonoMenwhich indicates the presence of an immunological memory for thesechildren. Remarkably, immune responses against strains not present inMonoMen were also observed. Cross-reacting antibodies possibly causethese responses. In spite of the somewhat weak response against P1.7h,4 after the primary vaccination series with the hexavalent vaccine, anadequate response against this strain was found after boosting withMonoMen. Based on these results in combination with the results of thephase II trial with MonoMen in toddlers MonoMen seems a safe and highlyimmunogenic vaccine.