Dosage Escalation, Safety and Immunogenicity Study of Four Dosages of a Tetravalent Meninogococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Infants

Abstract

MCV-4 appears to have a reactogenicity profile acceptable to parents and health care providers. It was only modestly immunogenic in infants, but it appeared to prime the immune system of the majority of infants given three doses in infancy. There is no statistically significant immunologic advantage conferred by increasing the dosage beyond 4 microg/ml, and local reactions are more frequent after the 10-microg/ml dosage.

Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age

“…One month after the 3-dose series, rSBA titers ≥8 were present in 54-92% of children, depending on the serogroup and the dose of polysaccharide contained in the vaccine. 28 The role of carrier proteins may be of relevance in this context, as previous studies have demonstrated differential immunogenicity in Hib vaccines using diphtheria toxoid or CRM 197 carrier proteins. 29,30 The percentages of subjects with hSBA titers ≥8 were lower against serogroup A than the other serogroups, an observation that has been reported in other studies.…”

“…22,27 By contrast, only modest immunogenicity after a 3-dose infant series was observed with a quadrivalent meningococcal vaccine conjugated to diphtheria toxoid. 28 In that study, immunogenicity was tested by SBA using rabbit complement (rSBA), which results in higher titers compared with when human complement is used. One month after the 3-dose series, rSBA titers ≥8 were present in 54-92% of children, depending on the serogroup and the dose of polysaccharide contained in the vaccine.…”

Genetic and Antigenic Analysis of Invasive Serogroup Y Neisseria meningitidis Isolates Collected from 1999 to 2003 in Canada

“…Purified capsular polysaccharide vaccines have been used to protect against N. meningitidis serogroups A, C, Y, and W135 (2). Diphtheria or tetanus toxoid-conjugated A and C polysaccharide vaccines have also been developed (9), and more recently a conjugated tetravalent vaccine against A, C, Y, and W135 has been licensed in the United States and Canada (21,23). No safe and effective vaccine against all strains of serogroup B meningococci has been developed due to the poor immunogenicity of the serogroup B capsule, which shares a common molecular structure with the carbohydrate component of the neural cell adhesion molecule (n-CAM) in humans (11,13).…”

Update on the Use of Quadrivalent Conjugate Meningococcal Vaccines

“…(28)(31) (32) Men-C-ACYW-135-D (Menactra™) has been found to be only modestly immunogenic in infants, but appears to prime the immune response in the majority of infants given three doses. (49) Based on available published data,Men-C-ACYW-135-CRM (Menveo™) is the recommended product in this age group. Possible schedules for vaccinating high-risk infants and young children based on clinical trials of immunogenicity can be found in Table 12.…”