Article

Immunogenicity and safety of a meningococcal quadrivalent conjugate vaccine in Saudi Arabian adolescents previously vaccinated with one dose of bivalent and quadrivalent meningococcal polysaccharide vaccines: a phase III, controlled, randomized, and modified blind-observer study.

Ministry of Health, Riyadh, Saudi Arabia.
Clinical and vaccine Immunology: CVI (Impact Factor: 2.37). 05/2012; 19(7):999-1004. DOI: 10.1128/CVI.00039-12
Source: PubMed

ABSTRACT Reduced immune responses to repeated polysaccharide vaccination have been previously reported, but there are limited immunogenicity data on the use of meningococcal polysaccharide vaccine (PSV) followed by meningococcal conjugate vaccine. Saudi Arabian adolescents (aged 16 to 19 years) who had previously been vaccinated with ≥1 dose of bivalent meningococcal polysaccharide vaccine and 1 dose of quadrivalent meningococcal polysaccharide (MPSV4) were enrolled in a controlled, randomized, and modified observer-blind study (collectively termed the PSV-exposed group). The PSV-exposed group was randomized to receive either quadrivalent meningococcal conjugate vaccine (MCV4) (n = 145 PSV-exposed/MCV4 group) or MPSV4 (n = 142 PSV-exposed/MPSV4 group), and a PSV-naïve group received MCV4 (n = 163). Serum samples collected prevaccination and 28 days postvaccination were measured by baby rabbit serum bactericidal antibody (rSBA) assay, and vaccine tolerability and safety were also evaluated. For each serogroup, the postvaccination geometric mean titers (GMTs) were significantly higher in the PSV-naïve group than in either group comprised of the PSV-exposed participants. The postvaccination serogroup C rSBA GMT was significantly higher in the PSV-MCV4 group than in the PSV-MPSV4 group after adjusting for prevaccination GMTs. Although not statistically significant, similar differences were observed for serogroups A, Y, and W-135. No worrisome safety signals were detected. This study demonstrated MCV4 to be safe and immunogenic in those who had previously received polysaccharide vaccination, and it suggests that conjugate vaccine can partially compensate for the hyporesponsiveness seen with repeated doses of polysaccharide vaccine.

0 Bookmarks
 · 
190 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Following repeated polysaccharide vaccination, reduced immune responses have been reported, but there are limited data on the mucosal response of meningococcal polysaccharide vaccine (PSV) or meningococcal conjugate vaccination. Saudi Arabian adolescents (aged 16-19 years) who had previously been vaccinated with ≥1 dose of bivalent meningococcal polysaccharide vaccine and 1 dose of quadrivalent meningococcal polysaccharide (MPSV4) were enrolled in a controlled, randomised, and modified observer-blind study (collectively termed the PSV-exposed group). The PSV-exposed group was randomised to receive either quadrivalent meningococcal conjugate vaccine (MCV4) (PSV-exposed/MCV4 group) or MPSV4 (PSV-exposed/MPSV4 group), and a PSV-naïve group received MCV4. Serum and saliva samples were collected pre-vaccination and 28 days post-vaccination. Serum serogroup-specific A, C, W and Y IgG were quantified as were salivary serogroup-specific C IgG and IgA together with total salivary IgG and IgA. For each serogroup, the post-vaccination serum geometric mean concentrations (GMCs) were significantly higher in the PSV-naïve and the PSV-exposed/MCV4 group than in the PSV-exposed/PSV4 group. For serogroup C, serum serogroup-specific IgG for the PSV-naïve group was significantly higher than both the PSV exposed groups. Higher levels of salivary serogroup C-specific IgG were found in the PSV-naïve group than those who had received two doses of polysaccharide but no significant differences were noted with regards to serogroup-specific IgA.
    Vaccine 08/2014; 32(43). DOI:10.1016/j.vaccine.2014.08.026 · 3.49 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: To assess the safety and immunogenicity of a quadrivalent meningococcal (groups A,C,Y,W) polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-DT) in India.
    Indian pediatrics 06/2014; 51(6):451-6. DOI:10.1007/s13312-014-0435-7 · 1.01 Impact Factor
  • [Show abstract] [Hide abstract]
    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.
    Advances in Therapy 05/2013; DOI:10.1007/s12325-013-0032-5 · 2.44 Impact Factor

Full-text (2 Sources)

Download
36 Downloads
Available from
May 20, 2014