Borja-Tabora Charissa Fay Corazon, Montalban Cecilia, Memish Ziad A, Boutriau Dominique, Kolhe Devayani, Miller Jacqueline M, Van der Wielen Marie
Research Institute for Tropical Medicine, Corporate Ave, Muntinlupa City, 1781, Metro Manila, Philippines.
Philippine General Hospital Manila, Taft Avenue, Ermita, Manila, 1000, Metro Manila, Philippines.
BMC Infect Dis. 2015 Oct 6;15:409. doi: 10.1186/s12879-015-1138-y.
Long-term protection against meningococcal disease is associated with persistence of post-vaccination antibodies at protective levels. We evaluated the bactericidal antibody persistence and safety of the quadrivalent meningococcal serogroups A, C, W and Y tetanus-toxoid conjugate vaccine (MenACWY-TT) and the meningococcal polysaccharide serogroups A, C, W, and Y vaccine (MenACWY-PS) up to 5 years post-vaccination.
This phase IIb, open, randomized, controlled study conducted in the Philippines and Saudi Arabia consisted of a vaccination phase and a long-term persistence phase. Healthy adolescents and adults aged 11-55 years were randomized (3:1) to receive a single dose of MenACWY-TT (ACWY-TT group) or MenACWY-PS (Men-PS group). Primary and persistence results up to 3 years post-vaccination have been previously reported. Antibody responses against meningococcal serogroups A, C, W, and Y were assessed by a serum bactericidal antibody assay using rabbit complement (rSBA, cut-off titers 1:8 and 1:128) at Year 4 and Year 5 post-vaccination. Vaccine-related serious adverse events (SAEs) and cases of meningococcal disease were assessed up to Year 5.
Of the 500 vaccinated participants, 404 returned for the Year 5 study visit (Total Cohort Year 5). For the Total Cohort Year 5, 71.6-90.0 and 64.9-86.3 % of MenACWY-TT recipients had rSBA titers ≥1:8 and ≥1:128, respectively, compared to 24.8-74.3 and 21.0-68.6 % of MenACWY-PS recipients. The rSBA geometric mean titers (GMTs) remained above the pre-vaccination levels in both treatment groups. Exploratory analyses suggested that both rSBA GMTs as well as the percentages of participants with rSBA titers above the cut-offs were higher in the ACWY-TT than in the Men-PS group for serogroups A, W and Y, with no apparent difference for MenC. No SAEs related to vaccination or cases of meningococcal disease were reported up to Year 5.
These results suggest that a single dose of MenACWY-TT could protect at least 72 % of vaccinated adolescents and adults against meningococcal disease at least 5 years post-vaccination.
ClinicalTrials.gov NCT00356369.
对脑膜炎球菌病的长期保护与接种疫苗后抗体在保护水平的持续存在有关。我们评估了四价A、C、W和Y血清群脑膜炎球菌破伤风类毒素结合疫苗（MenACWY-TT）和A、C、W和Y血清群脑膜炎球菌多糖疫苗（MenACWY-PS）接种后长达5年的杀菌抗体持续性和安全性。
这项在菲律宾和沙特阿拉伯进行的IIb期、开放、随机、对照研究包括一个疫苗接种阶段和一个长期持续性阶段。11至55岁的健康青少年和成年人被随机分组（3:1），分别接受单剂量的MenACWY-TT（ACWY-TT组）或MenACWY-PS（Men-PS组）。此前已报告了接种疫苗后长达3年的主要和持续性结果。在接种疫苗后第4年和第5年，通过使用兔补体的血清杀菌抗体检测（rSBA，临界滴度1:8和1:128）评估针对A、C、W和Y血清群脑膜炎球菌的抗体反应。评估了直至第5年与疫苗相关的严重不良事件（SAE）和脑膜炎球菌病病例。
在500名接种疫苗的参与者中，404人返回参加第5年的研究随访（总队列第5年）。对于总队列第5年，MenACWY-TT接种者中分别有71.6 - 90.0%和64.9 - 86.3%的rSBA滴度≥1:8和≥1:128，而MenACWY-PS接种者中这一比例分别为24.8 - 74.3%和21.0 - 68.6%。两个治疗组的rSBA几何平均滴度（GMT）均保持在接种疫苗前水平之上。探索性分析表明，对于A、W和Y血清群，ACWY-TT组的rSBA GMT以及rSBA滴度高于临界值的参与者百分比均高于Men-PS组，对于C血清群则无明显差异。直至第5年，未报告与疫苗相关的SAE或脑膜炎球菌病病例。
这些结果表明，单剂量的MenACWY-TT可在接种疫苗后至少5年内保护至少72%的接种青少年和成年人免受脑膜炎球菌病侵害。
ClinicalTrials.gov NCT00356369。
