Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults

Nancy Bermal, Li Min Huang, Ashish P. Dubey, Hermant Jain, Ashish Bavdekar, Tzou Yien Lin, Veronique Bianco, Yaela Baine, Jacqueline M. Miller

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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-naïve 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™, 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.

Original languageEnglish
Pages (from-to)239-247
Number of pages9
JournalHuman Vaccines
Volume7
Issue number2
DOIs
Publication statusPublished - Feb 2011
Externally publishedYes

Fingerprint

Conjugate Vaccines
Safety
Vaccination
Vaccines
Meningococcal Vaccines
Tetanus Toxoid
Philippines
Incidence
Taiwan
Polysaccharides
India
Young Adult
Serogroup
Rabbits
Serum

Keywords

  • Adolescent
  • Bactericidal activity
  • Conjugate vaccine
  • Immunogenicity
  • Safety
  • Tetravalent meningococcal vaccine

ASJC Scopus subject areas

  • Immunology
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults. / Bermal, Nancy; Huang, Li Min; Dubey, Ashish P.; Jain, Hermant; Bavdekar, Ashish; Lin, Tzou Yien; Bianco, Veronique; Baine, Yaela; Miller, Jacqueline M.

In: Human Vaccines, Vol. 7, No. 2, 02.2011, p. 239-247.

Research output: Contribution to journalArticle

Bermal, N, Huang, LM, Dubey, AP, Jain, H, Bavdekar, A, Lin, TY, Bianco, V, Baine, Y & Miller, JM 2011, 'Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults', Human Vaccines, vol. 7, no. 2, pp. 239-247. https://doi.org/10.4161.hv.7.2.14068
Bermal, Nancy ; Huang, Li Min ; Dubey, Ashish P. ; Jain, Hermant ; Bavdekar, Ashish ; Lin, Tzou Yien ; Bianco, Veronique ; Baine, Yaela ; Miller, Jacqueline M. / Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults. In: Human Vaccines. 2011 ; Vol. 7, No. 2. pp. 239-247.
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