Publication: Meningococcal polysaccharide A O-acetylation levels do not impact the immunogenicity of the quadrivalent meningococcal tetanus toxoid conjugate vaccine: Results from a randomized, controlled phase III study of healthy adults aged 18 to 25 years
Issued Date
2013-10-01
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ISSN
1556679X
15566811
15566811
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2-s2.0-84886732590
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Mahidol University
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SCOPUS
Bibliographic Citation
Clinical and Vaccine Immunology. Vol.20, No.10 (2013), 1499-1507
Suggested Citation
Socorro Lupisan, Kriengsak Limkittikul, Nestor Sosa, Pornthep Chanthavanich, Véronique Bianco, Yaela Baine, Marie Van Der Wielen, Jacqueline M. Miller Meningococcal polysaccharide A O-acetylation levels do not impact the immunogenicity of the quadrivalent meningococcal tetanus toxoid conjugate vaccine: Results from a randomized, controlled phase III study of healthy adults aged 18 to 25 years. Clinical and Vaccine Immunology. Vol.20, No.10 (2013), 1499-1507. doi:10.1128/CVI.00162-13 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/31206
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Title
Meningococcal polysaccharide A O-acetylation levels do not impact the immunogenicity of the quadrivalent meningococcal tetanus toxoid conjugate vaccine: Results from a randomized, controlled phase III study of healthy adults aged 18 to 25 years
Abstract
In this study, we compared the immunogenicities of two lots of meningococcal ACWY-tetanus toxoid conjugate vaccine (MenACWY-TT) that differed in serogroup A polysaccharide (PS) O-acetylation levels and evaluated their immunogenicities and safety in comparison to a licensed ACWY polysaccharide vaccine (Men-PS). In this phase III, partially blinded, controlled study, 1,170 healthy subjects aged 18 to 25 years were randomized (1:1:1) to receive one dose of MenACWY-TT lot A (ACWY-A) (68% O-acetylation), MenACWY-TT lot B (ACWY-B) (92% O-acetylation), or Men-PS (82% O-acetylation). Immunogenicity was evaluated in terms of serum bactericidal activity using rabbit complement (i.e., rabbit serum bactericidal activity [rSBA]). Solicited symptoms, unsolicited adverse events (AEs), and serious AEs (SAEs) were recorded. The immunogenicities, in terms of rSBA geometric mean titers, were comparable for both lots of MenACWY-TT. The vaccine response rates across the serogroups were 79.1 to 97.0% in the two ACWY groups and 73.7 to 94.1% in the Men-PS group. All subjects achieved rSBA titers of ≥1:8 for all serogroups. All subjects in the two ACWY groups and 99.5 to 100% in the Men-PS group achieved rSBA titers of ≥1:128. Pain was the most common solicited local symptom and was reported more frequently in the ACWY group (53.9 to 54.7%) than in the Men-PS group (36.8%). The most common solicited general symptoms were fatigue and headache, which were reported by 28.6 to 30.3% and 26.9 to 31.0% of subjects, respectively. Two subjects reported SAEs; one SAE was considered to be related to vaccination (blighted ovum; ACWY-B group). The level of serogroup A PS O-acetylation did not affect vaccine immunogenicity. Men-ACWY-TT (lot A) was not inferior to Men-PS in terms of vaccine response and was well tolerated. Copyright © 2013, American Society for Microbiology. All Rights Reserved.