CopperView Medical Center, South Jordan, UT, United States.
Brownsboro Park Pediatrics, Louisville, KY, United States.
Vaccine. 2019 Sep 30;37(42):6171-6179. doi: 10.1016/j.vaccine.2019.08.065. Epub 2019 Sep 5.
Vaccination strategies against bacterial meningitis vary across countries. In the United States, a single dose of quadrivalent meningococcal conjugate vaccine (MenACWY) is recommended at 11-12 years of age, with a booster dose approximately 5 years later. We assessed immune responses to a booster dose of MenACWY-CRM vaccine after priming with MenACWY-CRM or MenACWY-D vaccines in adolescents and adults.
In this phase IIIb, multicenter, open-label study, healthy 15-55-year-olds, who received MenACWY-CRM (N = 301) or MenACWY-D (N = 300) 4-6 years earlier or were meningococcal vaccine-naïve (N = 100), received one MenACWY-CRM vaccine dose. Immunogenicity was evaluated pre-vaccination, 3 or 5 days post-vaccination (sampling subgroups), and 28 days post-vaccination by serum bactericidal activity assay using human complement (hSBA). After vaccination, participants were monitored for 7 days for reactogenicity, 29 days for unsolicited adverse events (AEs), and 181 days for serious AEs and medically-attended AEs.
Sufficiency of the immune response to a MenACWY-CRM booster dose was demonstrated; the lower limit of the 1-sided 97.5% confidence interval for percentages of participants with hSBA seroresponse at 28 days post-vaccination was >75% for each serogroup in those primed with either the MenACWY-CRM or MenACWY-D vaccine. Seroresponse was observed in ≥93.24% of primed participants and ≥35.87% of naïve participants 28 days post-vaccination. At 5 days post-booster, among primed participants, hSBA titers ≥1:8 were achieved in ≥47.14% of participants for MenA and in ≥85.52% of participants for MenC, MenW and MenY, and 3.25- to 8.59-fold increases in hSBA geometric mean titers against each vaccine serogroup were observed. No safety concerns were raised throughout the 6-month follow-up period.
A booster dose of the MenACWY-CRM vaccine induced a robust and rapid anamnestic response in adolescents and adults, irrespectively of either MenACWY-CRM or MenACWY-D vaccine administered 4-6 years earlier, with an acceptable clinical safety profile. ClinicalTrials.gov registration: NCT02986854.
针对细菌性脑膜炎的疫苗接种策略在各国之间存在差异。在美国，建议在 11-12 岁时接种一剂四价脑膜炎球菌结合疫苗（MenACWY），大约 5 年后再接种加强剂。我们评估了青少年和成年人在接种 MenACWY-CRM 疫苗前接种 MenACWY-CRM 或 MenACWY-D 疫苗后的 MenACWY-CRM-CRM 疫苗加强剂的免疫反应。
在这项 IIIb 期、多中心、开放标签研究中，301 名 15-55 岁健康个体在 4-6 年前接受过 MenACWY-CRM（N=301）或 MenACWY-D（N=300）接种，或为脑膜炎球菌疫苗接种初免者（N=100），接受了一剂 MenACWY-CRM 疫苗接种。在接种前、接种后 3 或 5 天（采样亚组）和接种后 28 天通过使用人补体的血清杀菌活性测定（hSBA）评估免疫原性。接种后，对参与者进行 7 天的不良反应监测，29 天的不良事件（AE），以及 181 天的严重 AE 和需要医疗干预的 AE。
证明了 MenACWY-CRM 加强剂的免疫反应是充足的；在接种 MenACWY-CRM 或 MenACWY-D 疫苗的个体中，每个血清型组在接种后 28 天的 hSBA 血清应答率的下限在 97.5%单侧置信区间内>75%。在接种后 28 天，在接种过的参与者中观察到≥93.24%的血清应答，在初免者中观察到≥35.87%的血清应答。在接种后 5 天，在接种过的参与者中，≥47.14%的参与者的 hSBA 滴度≥1:8，≥85.52%的参与者的 hSBA 滴度≥MenC，MenW 和 MenY 的 MenA，并且针对每个疫苗血清型组的 hSBA 几何平均滴度增加了 3.25-8.59 倍。在整个 6 个月的随访期间，未发现安全性问题。
MenACWY-CRM 疫苗加强剂在青少年和成年人中诱导了强大而快速的回忆反应，与 4-6 年前接种的 MenACWY-CRM 或 MenACWY-D 疫苗无关，具有可接受的临床安全性。临床试验注册：NCT02986854。
