Immunogenicity and Safety of a Meningococcal Serogroup A, C, Y and W Glycoconjugate Vaccine, ACWY-TT

Abstract

A quadrivalent meningococcal serogroup A, C, W and Y conjugate vaccine (ACWY), utilising tetanus toxoid (TT) as its carrier protein (ACWY-TT; Nimenrix™, GlaxoSmithKline Vaccines, Rixensart, Belgium) has been demonstrated to be safe and immunogenic when administered to young children from 12 months of age, older children, adolescents, and adults. Administration of a single dose of ACWY-TT induces protective serum bactericidal antibodies against all four serogroups as well as good antibody persistence. Coadministration studies have demonstrated that ACWY-TT can be administered with diphtheria, tetanus, three-component acellular pertussis, hepatitis B, inactivated polio virus and Haemophilus influenzae type b conjugate vaccine (DTaP3-IPV-HBV/Hib, Infanrix™ hexa; GlaxoSmithKline Vaccines, Rixensart, Belgium); measles, mumps, rubella, varicella vaccine (Priorix-Tetra™; GlaxoSmithKline Vaccines, Rixensart, Belgium); 10-valent pneumococcal conjugate vaccine (Synflorix(®); GlaxoSmithKline Vaccines, Rixensart, Belgium); hepatitis A and B vaccine (Twinrix(®); GlaxoSmithKline Vaccines, Rixensart, Belgium); and seasonal influenza vaccine (Fluarix™; GlaxoSmithKline Vaccines, Rixensart, Belgium). Studies in young infants from 2 months of age have now commenced but immunisation with a single dose of ACWY-TT from 12 months of age is a safe and immunogenic option in the prevention of meningococcal disease.

Development and Use of a Serum Bactericidal Assay Using Pooled Human Complement To Assess Responses to a Meningococcal Group A Conjugate Vaccine in African Toddlers

“…The rapid decline in hSBA titers following a single dose has been observed with other group A meningococcal conjugate vaccines (16)(17)(18)(19)(20) and is consistent with observations reported in this population for rSBA GMT and IgG GMC. However, the magnitude of hSBA response is much less, and by threshold analyses, hSBA persists in a smaller proportion of the immunized group than indicated by rSBA or IgG ELISA immunoassays (2).…”

Safety and immunogenicity of a four-component meningococcal group B vaccine (4CMenB) and a quadrivalent meningococcal group ACWY conjugate vaccine administered concomitantly in healthy laboratory workers

“…The more discriminatory rSBA titre of ≥128 reliably predicts a hSBA titre of ≥4 [16], the accepted hSBA correlate of protection for group B [17,18]. Although an anticapsular Ig concentration of ≥2 g/mL has historically been used for group A [19], there are currently no established SBA correlates for groups A, W and Y; therefore, the group C rSBA correlate was applied in line with previous studies [20].…”

Randomized Trial to Compare the Immunogenicity and Safety of a CRM or TT Conjugated Quadrivalent Meningococcal Vaccine in Teenagers who Received a CRM or TT Conjugated Serogroup C Vaccine at Preschool Age

“…Novartis MenACWY contains capsular oligosaccharides conjugated to CRM197, 15 whereas GSK MenACWY is conjugated to TT. [16][17][18] Primary vaccines used in the original study were previously described. 12 Reactions were monitored via telephone, selfcompleted diary and enquiry at study visits.…”

“…Notwithstanding, our findings are compatible with other data indicating shorter antibody persistence after vaccination in younger relative to older age-groups. 19,29 Others have, however, estimated a slower annual 23% decline (95% CI: [15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] in odds of protection after Meningitec vaccination at age 13-45 months. 30 This study also provided long-term (12-14 years) postprimary antibody persistence data in individuals primed at preschool age.…”