|Title:||Safety and Immunogenicity of a Tetravalent Meningococcal Serogroups a, C, W-135 and Y Conjugate Vaccine in Adolescents and Adults||Authors:||Bermal, Nancy
|Keywords:||tetravalent meningococcal vaccine;conjugate vaccine;bactericidal activity;adolescent;safety;immunogenicity||Issue Date:||2011||Start page/Pages:||239-247||Source:||Human Vaccines||Abstract:||
The highest incidence of invasive meningococcal disease is in young children, with a second peak in adolescents/young adults. All five major disease-causing serogroups A, B, C, W -135 and Y have been described in Asia. Immunogenicity and safety of the investigational meningococcal ACWY- tetanus toxoid conjugate vaccine ACWY-TT, GlaxoSmithKline Biologicals was evaluated in healthy, meningococcal conjugate vaccine-nave adolescents in the Philippines, India and Taiwan. 1,025 adolescents were randomized 3:1 to receive one dose of ACWY-TT or tetravalent ACWY polysaccharide vaccine Mencevax TM, Men-PS. Serum bactericidal activity using rabbit complement rSBA was measured. Local and systemic adverse reactions were recorded for 4 days. Safety data were pooled with results from a second, similarly designed study in adults for evaluation of grade 3 systemic events. The pre-specified immunogenicity criterion for non-inferiority to Men-PS was met. One month post-vaccination, >= 85.4%-97.1% had a vaccine response post -titre >= 1:8 in initially seronegative and >= 4-fold increase in seropositive, versus 78.0%-96.6% after Men-PS, against each vaccine serogroup. Exploratory comparisons showed statistically significantly higher post-vaccination rSBA geometric mean titres against all serogroups following ACWY-TT versus Men-PS. Exploratory analysis showed no statistically significant differences between groups in grade 3 general symptoms; however, the statistical criterion for non-inferiority between pooled treatment groups in terms of the ratio of incidences of grade 3 general symptoms was not demonstrated. No SAEs were related to vaccination . ACWY-TT was immunogenic in Asian adolescents with a reactogenicity profile that was clinically acceptable and similar to that of licensed Men -PS. The results of this study indicate that ACWY-TT could be used as a third conjugate vaccine in the protection of adolescents against meningococcal disease.
|Appears in Collections:||醫學系|
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