A群C群脑膜炎球菌结合疫苗安全性和免疫原性

胡家垒; 胡月梅; 梁祁; 储凯; 李靖欣; 孟繁岳; 朱凤才

doi:10.11847/zgggws1124496

A群C群脑膜炎球菌结合疫苗安全性和免疫原性

Immunogenicity and safety of a meningococcal serogroups A and C tetanus toxoid conjugate vaccine in 3-month – 5-year old children: a phase III, single-center, randomized controlled trial

摘要

摘要:
目的评价A群C群脑膜炎球菌结合疫苗的安全性和免疫原性。
方法于2016年5月 — 2017年9月，选取江苏省淮安市涟水县辖区内1 799名3月龄～5岁婴幼儿进行III期临床试验，按照1 : 1的比例随机接种试验或对照疫苗。其中3～5月龄和6～11月龄试验组受试者在18月龄时进行加强免疫。每针次接种后对受试者进行安全性观察，并采集各年龄组受试者免疫前、基础免疫后28 d以及3～5月龄和6～11月龄组受试者18月龄和加强免疫后28 d的血清样本进行免疫原性观察。
结果 2～5岁、12～23月龄、6～11月龄和3～5月龄试验组，总体征集性不良反应发生率分别为33.11 %，58.28 %，75.33 %和85.62 %，以1级（轻度）不良反应为主，试验组与对照组比较差异均无统计学意义；基础免疫后，各试验组A群抗体阳转率分别为98.60 %，100 %，100 %和96.56 %，C群抗体阳转率分别为81.21 %，98.52 %，96.35 %和97.70 %，其中6～11月龄试验组与对照组A群抗体阳转率差异有统计学意义（χ²_6～11M = 11.554 6，P = 0.000 7）其他年龄试验与对照组差异均无统计学意义，试验组均非劣效于对照组。3～5月龄和6～11月龄组加强免疫后，A群和C群阳转率几乎均达100 %。
结论试验组A群C群脑膜炎球菌结合疫苗在3月龄～5岁易感人群中具有良好的安全性和免疫原性。

Abstract:
Objective To evaluate the immunogenicity and safety of a meningococcal serogroups A and C tetanus toxoid conjugate vaccine (MenAC-TT).
Methods From May 2016 to September 2017, in a phase III clinical trial, 1 799 participants aged 3-month to 5-year received test and control MenAC-TT vaccination at the ratio of 1 : 1; the participants aged 6 – 11 months and 3 – 5 months received a boost vaccination at month 18. Safety observation was conducted during 28 days after each vaccination. Blood samples were collected at the day 28 post vaccination and month 18 and the day 28 post boost in 6 – 11 months and 3 – 5 months participants.
Results The overall incidence of solicited adverse effects after vaccination in the 2 – 5 years, 12 – 23 months, 6 – 11 months and 3 – 5 months children of test groups were 33.11%, 58.28%, 75.33%, and 85.62%, respectively. The majority of the adverse effects were all gradeⅠ (mild) and no significant difference in the adverse effects was observed between the test and control group. After the primary vaccination, seroconversion rates were 98.60%, 100%, 100%, and 96.56% for MenA and 81.21%, 98.52%, 96.35%, 97.70% for MenC in the children of 4 test groups. The seroconversion rate was not significantly different between test and control groups of various ages, except for the children aged 6 – 11 months (χ² = 11.554 6, P = 0.000 7), indicating a non-inferiority of the MenAC-TT vaccination compared to the control. After boost, the seroconversion rates for MenA and MenC were approximately 100% in both 3 – 5 months and 6 – 11 months children of test groups.
Conclusion The meningococcal serogroups A and C tetanus toxoid conjugate vaccine is of good safety and high immunogenicity for 3-month to 5-year old susceptible children.

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