Immunogenicity of a serogroup B meningococcal vaccine against multiple Neisseria meningitidis strains in infants.

Abstract

The serogroup B meningococcus is responsible for the majority of cases of meningococcal disease in temperate countries. Infants and young children <2 years of age are at greatest risk of disease. This study assessed the immunogenicity in infants of a serogroup B meningococcal outer membrane protein vaccine that has been used extensively in disease outbreaks in Cuba and several Latin American countries and shown to be efficacious in teenagers. One hundred five healthy infants entering the routine vaccination schedule in Havana, Cuba, were given either 2 or 3 doses of the serogroup B meningococcal vaccine VA-MENGOC-BC at 3.5, 5.5 and 7.5 months of age. Immune response pre- and postvaccination was determined by the conventional serum bactericidal assay (SBA), a more sensitive novel whole blood bactericidal assay (WBA) and immunoglobulin ELISA. In 52 and 46% of infants >50% killing of the vaccine serogroup B strain (B:4:P1.19,15) and serogroup C strain, respectively, was demonstrated by the WBA after 2 doses of the vaccine. Serum bactericidal activity (4-fold increase in titer) was induced in only 27% against the vaccine serogroup B strain and in 14% against the serogroup C strain. The changes in WBA and SBA were mirrored by the serogroup B and C immunoglobulin ELISA. Cross-reactive immunogenicity against other (heterologous) serogroup B strains was demonstrated for one of the four further strains assessed by WBA. By age 16 to 18 months SBA, WBA and ELISA responses had declined considerably. The addition of a third dose of vaccine did not appear to significantly influence immunogenicity at 17 months of age. The serogroup B outer membrane protein vaccine VA-MENGOC-BC induces a demonstrable immune response in infants against both the serogroup B vaccine strain and against a serogroup C strain. Cross-reactive immunogenicity against other (heterologous) serogroup B strains is limited in this age group.