3月龄婴儿接种A群C群脑膜炎球菌多糖结合疫苗的免疫原性和不良反应

Immunogenicity and adverse reactions to group A and group C meningococcal polysaccharide conjugate vaccine among 3-month-old infants

目的评价3月龄婴儿接种一种新上市的A群C群脑膜炎球菌多糖结合疫苗(MPCV-AC)的免疫原性和不良反应。方法采用随机、盲法、同类疫苗对照的临床试验设计,招募3月龄婴儿按照1:1比例分别接种3剂本研究试验疫苗和另一种已上市使用的对照疫苗,检测免疫前和全程免疫后30d A群、C群脑膜炎奈瑟菌(Nm)抗体,观察全程免疫后0-30d不良反应和6个月内严重不良事件(SAE),比较抗体阳转率、几何平均滴度(GMT)和不良反应发生率。结果试验组、对照组均入组受试婴儿276名。两组MPCV-AC免疫后A群Nm抗体阳转率分别为86.80%、86.92%(x2=0.002,P=0.967),GMT分别为1:48.50、1:43.02(t=0.74,P=0.460);C群Nm抗体阳转率分别为91.20%、90.38%(x2=0.10,P=0.750),GMT分别为1:63.12、1:57.99(校正t=0.68,P=0.495)。两组免疫后0-30d总不良反应发生率分别为18.9%、29.2%(x2=23.25,P<0.001),其中局部不良反应分别为1.9%、7.1%(x2=25.32,P<0.001),全身不良反应分别为17.3%、24.8%(x2=13.83,P<0.001);两组均无4级不良反应或SAE发生。结论3月龄婴儿接种本研究MPCV-AC具有良好的免疫原性且不良反应发生率低。

Objective To evaluate immunogenicity and adverse reactions of a newly-licensed group A and group C meningococcal polysaccharide con jugate vaccine(MPCV-AC) among 3-month-old inf ants. Methods We used a randomized, blinded, similar-vaccine-controlled clinical trial design to recruit 3-month-old infants and assigned them in a 1:1 ratio to receive 3 doses of the study MPCV-AC or 3 doses of a marketed MPCV-AC as control. We tested for group A and group C Neisseria meningitidis(Nm) antibodies before and 30 days af ter vaccination and observed adverse reactions 0-30 days following vaccination and serious adverse events within 6 months of vaccination. We compared seroconversion rates, geometric mean titers(GMTs) of antibodies, and incidences of adverse reactions. Results We recruited 276 infants into each of the study group and the control group. Af ter MPCV-AC vaccination, seroconversion rates of group A Nm antibody f or the two groups were 86.80% and 86.92%(x2=0.002, P=0.967), respectively, with GMTs being 1:48.50 and 1:43.02(t=0.74, P=0.460);seroconversion rates of group C Nm antibody for the two groups were 91.20% and 90.38%(x2=0.10, P=0.750) with GMT being 1:63.12 and 1:57.99(adjusted t=0.68, P=0.495). The overall incidence of adverse reactions within 0-30 days of vaccination for the two groups were 18.9% and 29.2%(x2=23.25, P<0.001), with 1.9% and 7.1%(x2=25.32, P<0.001) for local adverse reactions and 17.3% and 24.8%(x2=13.83, P<0.001) f or systemic adverse reactions. No grade 4 adverse reactions or serious adverse events were observed in either group. Conclusions The study MPCV-AC had good immunogenicity and a lower incidence of adverse reactions among 3-month-old infants than the MPCV-AC control vaccine.